Tuberculosis
Conditions
Keywords
Tuberculosis vaccine
Brief summary
This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals' candidate tuberculosis vaccine (692342) when administered concomitantly with or after the Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and including 2 and 7 months, living in a tuberculosis endemic region.
Interventions
BIOLOGICALGSK's investigational vaccine 692342
Intramuscular, 1 or 2 doses
BIOLOGICALTritanrix™ HB+Hib
Intramuscular, 3 doses
BIOLOGICALPrevnar™
Intramuscular, 3 doses
BIOLOGICALPolio Sabin™
Oral, 3 doses
BIOLOGICALMenjugate™
Intramuscular, 3 doses
Sponsors
Aeras
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 7 Months
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative (LAR(s)) can and will comply with the requirements of the protocol. * Written or oral, signed or thumb-printed and witnessed informed consent obtained from the subject's parent(s)/LAR(s). * Subjects who received their birth dose of Bacille Calmette Guerrin. * Healthy subjects as established by medical history and clinical examination before entering into the study. For the 'Outside Expanded Programme on Immunisation' cohort: * Must have documented evidence that he/she has completed the primary Expanded Programme on Immunisation regimen at least 1 month prior to planned vaccination with investigational vaccination regimen. * Aged between 5 and 7 months at the time of the first study vaccination. For the 'Within EPI' cohort: * Must have received the birth dose of Bacille Calmette Guerrin, oral polio vaccine and Hepatitis B vaccine but NO further Expanded Programme on Immunisation vaccines. * Aged between 2 and 4 months at the time of the first study vaccination with diphtheria, tetanus, whole cell pertussis/ Haemophilus influenzae type b vaccine + pneumococcal conjugate vaccine + oral polio vaccine.
Exclusion criteria
* Child in care * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal abnormality, as determined by physical examination and/or laboratory screening tests. * Laboratory screening tests out of range, which in the investigator's opinion affects the ability of the child to take part in the study. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * A family history of congenital or hereditary immunodeficiency. * Major congenital defects. * History of any neurological disorders or seizures. * Any condition or illness or medication, which in the opinion of the investigator might interfere with the evaluation of the safety or immunogenicity of the study vaccine. * Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial. * Acute disease and/or fever at the time of enrolment. * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * For the 'Within Expanded Programme on Immunisation' Cohort only: Previous vaccination with diphtheria, tetanus, pertussis, Haemophilus influenzae type b and pneumococcal conjugate vaccine. * History of previous administration of experimental Mycobacterium tuberculosis vaccines. * Administration of immunoglobulins, blood transfusions and/or other blood products since birth to the first dose of study vaccine or planned administration during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned participation or concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements * History of allergic reactions or anaphylaxis to any vaccine. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines. * Severe malnutrition at screening defined as weight-for-age Z-score \< -3 standard deviation. * Children will not be enrolled if any maternal, obstetrical or neonatal event that has occurred might, in the judgment of the investigator, result in increased neonatal/infant morbidity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | From Day 0 to Day 6 | Solicited local symptoms assessed were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. |
| Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | From Day 0 to Day 6 | Solicited local symptoms were only collected after Dose 2 of EPI vaccination. Solicited local symptoms assessed were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. |
| Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | From Day 0 to Day 6 | Solicited general symptoms assessed were drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability/fussiness and loss of appetite. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. |
| Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | From Day 0 to Day 6 | Solicited general symptoms were only collected after Dose 2 of EPI vaccination. Solicited general symptoms assessed were drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability/fussiness and loss of appetite. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. |
| Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs) | From Day 0 to Day 29 | An unsolicited adverse event is 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Month 0 to Month 17 | Serious adverse events (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 Grade 3 Haematological and Biochemical Levels | At Day 0 | Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 grams per deciliter (g/dL); WBC.: 1.0 to 1.4 x 10³/micro liter (µL); PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x upper limit of normal (ULN) and CREA: 3.1 to 6.0 x ULN. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-PRP Antibody Concentrations | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | Concentrations given in µg/mL were expressed as Geometric Mean Concentrations (GMCs). |
| Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT) | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | A seropositive subject was a subject whose anti-BPT antibody concentration was ≥ 15 EL.U/mL. |
| Anti-BPT Antibody Concentrations | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs). |
| Number of Seropositive Subjects Against Hepatitis B (Anti-HB) | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | A seropositive subject was a subject whose anti-HB antibody concentration was ≥ 10 milli-international units per millilitre (mIU/mL). |
| Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Following from this, the table shows data with titers ≥ 100 mIU/mL. |
| Anti-HB Antibody Concentrations | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | Concentrations given in mIU/mL were expressed as Geometric Mean Concentrations (GMCs). |
| Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | A seropositive subject was a subject whose anti-polio antibody titer was ≥ 1:8. |
| Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | Before vaccination (PRE) | Immune markers expressed were among Interleukin-2 (IL-2),Interferon-gamma (INF-γ),Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L). |
| Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | A seropositive subject was a subject whose anti-S pneumoniae antibody concentration was ≥ 0.05 µg/mL. |
| Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | A seroconverted subject is a vaccinated subject with at least a four fold increased antibody titer post vaccination. |
| Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | Concentrations, given in µg/mL, were expressed as Geometric Mean Concentrations (GMCs). |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 up to 12 months post last vaccination | Serious adverse events (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, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Before vaccination (PRE) | Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, G1, G2 and G4 . Values that did not fall under normal levels or assessed grades were missing. |
| Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Seven days post Dose 1 [PI(D7)] | Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were : normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing. |
| Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | Concentrations given in titers were expressed as Geometric Mean Titers (GMTs). |
| Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | Before vaccination (PRE) | Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L). |
| Number of Seropositive Subjects Against M72 Antigen | Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)] | A seropositive subject was a subject whose M72 antibody concentration was greater than or equal to 2.8 ELISA units per millilitre (EL.U/mL). |
| Concentration of Antibodies Against M72 Antigen | Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)] | Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs). |
| Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | A seroprotected subject was a subject whose anti-diphtheria toxoid (anti-D)/anti-tetanus toxoid (anti-T) antibody concentration was ≥ 0.1 international-units per millilitre (IU/mL). |
| Anti-D, Anti-T Antibody Concentrations | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | Concentrations given in IU/mL, were expressed as Geometric Mean Concentrations (GMCs). |
| Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP) | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] | A seroprotected subject was a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per millilitre (µg/mL). |
Countries
The Gambia
Participant flow
Pre-assignment details
One enrolled subject was not administered any vaccine and hence was not considered as having started the study.
Participants by arm
| Arm | Count |
|---|---|
| SB692342 2 Dose Group Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, on a 0, 1 month schedule after having completed their primary EPI regimen. | 50 |
| SB692342 1 Dose Group Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen. | 50 |
| Control Menjugate Group Subjects received three doses of the control Menjugate™ vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1, 7 months schedule. The first two doses were administered 1 month apart during the primary vaccination phase and the third dose was administered 6 months after the last primary vaccination dose. | 50 |
| SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, concomintantly with the last two doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered instramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose. | 49 |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, concomitantly with the last dose of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose. | 52 |
| Control Tritanrix + Prevnar + Polio Sabin Group Subjects received three doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose. | 49 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Active Phase | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 |
| Active Phase | Other | 0 | 0 | 3 | 0 | 0 | 0 |
| Active Phase | Withdrawal by Subject | 1 | 1 | 2 | 0 | 0 | 0 |
| Follow Up Phase | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
| Follow Up Phase | Other | 0 | 0 | 0 | 0 | 0 | 4 |
| Follow Up Phase | Travelled out of study area | 0 | 0 | 0 | 0 | 1 | 0 |
| Follow Up Phase | Withdrawal by Subject | 0 | 0 | 0 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | SB692342 2 Dose Group | SB692342 1 Dose Group | Control Menjugate Group | SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group | SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Control Tritanrix + Prevnar + Polio Sabin Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 5.8 Months STANDARD_DEVIATION 0.68 | 5.7 Months STANDARD_DEVIATION 0.61 | 5.7 Months STANDARD_DEVIATION 0.65 | 2.1 Months STANDARD_DEVIATION 0.28 | 2 Months STANDARD_DEVIATION 0.19 | 2.1 Months STANDARD_DEVIATION 0.31 | 3.9 Months STANDARD_DEVIATION 1.9 |
| Race/Ethnicity, Customized African heritage/African American | 50 Participants | 50 Participants | 50 Participants | 49 Participants | 52 Participants | 49 Participants | 300 Participants |
| Sex: Female, Male Female | 34 Participants | 20 Participants | 23 Participants | 25 Participants | 16 Participants | 23 Participants | 141 Participants |
| Sex: Female, Male Male | 16 Participants | 30 Participants | 27 Participants | 24 Participants | 36 Participants | 26 Participants | 159 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 1 / 50 | 0 / 49 | 0 / 52 | 0 / 49 |
| other Total, other adverse events | 33 / 50 | 22 / 50 | 31 / 50 | 34 / 49 | 22 / 52 | 26 / 49 |
| serious Total, serious adverse events | 2 / 50 | 3 / 50 | 3 / 50 | 1 / 49 | 1 / 52 | 1 / 49 |
Outcome results
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: Six Months post Dose 3 [At Month 13]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: At Month 8
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: At Month 7
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: At Month 12
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: At Month 14
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 1 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: Twelve Months post Dose 2 [At Month 13]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 grams per deciliter (g/dL); WBC.: 1.0 to 1.4 x 10³/micro liter (µL); PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x upper limit of normal (ULN) and CREA: 3.1 to 6.0 x ULN.
Time frame: At Day 0
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA, PRE, Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC, PRE, Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA, PRE, Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA, PRE, Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem, PRE, Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA, PRE, Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem, PRE, Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC, PRE, Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA, PRE, Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA, PRE, Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA, PRE, Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC, PRE, Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem, PRE, Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA, PRE, Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA, PRE, Grade 3 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem, PRE, Grade 3 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA, PRE, Grade 3 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA, PRE, Grade 3 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA, PRE, Grade 3 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC, PRE, Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem, PRE, Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA, PRE, Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA, PRE, Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA, PRE, Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC, PRE, Grade 3 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA, PRE, Grade 3 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC, PRE, Grade 3 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA, PRE, Grade 3 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem, PRE, Grade 3 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA, PRE, Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: At Day 7
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: At Day 37
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: At Day 67
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: At Month 1
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: At Month 2
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: At Month 3
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).Grade 3 = Haem.: \< 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: \< 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Time frame: At Month 6
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | Haem Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | WBC Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | PLA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | ALA Grade 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Haematological and Biochemical Levels | CREA Grade 3 | 0 Participants |
Primary
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses.
Solicited general symptoms assessed were drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability/fussiness and loss of appetite. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C.
Time frame: From Day 0 to Day 6
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Irritability, Across doses | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Loss of appetite, Across doses | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Temperature/Axillary, Across doses | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Irritability, Dose 1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Temperature /Axillary, Dose 1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Irritability, Dose 2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Temperature/Axillary, Dose 2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Drowsiness, Across doses | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Temperature /Axillary, Dose 1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Irritability, Across doses | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Irritability, Dose 2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Irritability, Dose 1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Loss of appetite, Across doses | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Temperature/Axillary, Dose 2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Temperature/Axillary, Across doses | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Drowsiness, Across doses | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Irritability, Dose 1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Drowsiness, Across doses | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Temperature /Axillary, Dose 1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Temperature/Axillary, Dose 2 | 1 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Loss of appetite, Across doses | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Temperature/Axillary, Across doses | 1 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Irritability, Across doses | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. | Grade 3 Irritability, Dose 2 | 0 Participants |
Primary
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses.
Solicited general symptoms were only collected after Dose 2 of EPI vaccination. Solicited general symptoms assessed were drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability/fussiness and loss of appetite. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C.
Time frame: From Day 0 to Day 6
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Irritability, Dose 2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Loss of appetite, Across doses | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Irritability, Dose 3 | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Irritability, Across doses | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Temperature/Axillary, Dose 3 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Temperature/Axillary, Dose 2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Drowsiness, Across doses | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Temperature/Axillary, Across doses | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Temperature/Axillary, Dose 2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Temperature/Axillary, Dose 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Temperature/Axillary, Across doses | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Irritability, Dose 2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Irritability, Dose 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Drowsiness, Across doses | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Irritability, Across doses | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Loss of appetite, Across doses | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Irritability, Across doses | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Temperature/Axillary, Dose 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Loss of appetite, Across doses | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Temperature/Axillary, Dose 2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Irritability, Dose 2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Drowsiness, Across doses | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Irritability, Dose 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Temperature/Axillary, Across doses | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Drowsiness, Dose 2 | 0 Participants |
Primary
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses
Solicited local symptoms assessed were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: From Day 0 to Day 6
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Swelling, Across doses | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Pain, Dose 2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Pain, Across doses | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Pain, Dose 1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Swelling, Dose 2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Swelling, Dose 1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Swelling, Dose 2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Pain, Across doses | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Swelling, Dose 1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Swelling, Across doses | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Pain, Dose 1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Pain, Dose 2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Swelling, Across doses | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Pain, Dose 1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Swelling, Dose 1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Pain, Dose 2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Swelling, Dose 2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses | Grade 3 Pain, Across doses | 0 Participants |
Primary
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses.
Solicited local symptoms were only collected after Dose 2 of EPI vaccination. Solicited local symptoms assessed were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: From Day 0 to Day 6
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Pain, Dose 2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Swelling, Across doses | 3 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Swelling, Dose 2 | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Pain, Dose 3 | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Swelling, Dose 3 | 3 Participants |
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Pain, Across doses | 2 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Pain, Dose 3 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Pain, Across doses | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Pain, Dose 2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Swelling, Dose 3 | 6 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Swelling, Across doses | 6 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Swelling, Dose 2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Swelling, Across doses | 5 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Swelling, Dose 2 | 2 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Pain, Dose 3 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Swelling, Dose 3 | 3 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Pain, Across doses | 0 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. | Grade 3 Pain, Dose 2 | 0 Participants |
Primary
Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs)
An unsolicited adverse event is 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.
Time frame: From Day 0 to Day 29
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs) | 28 Participants |
| SB692342 1 Dose Group | Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs) | 25 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs) | 27 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs) | 14 Participants |
| Control Menjugate Group | Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs) | 26 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs) | 22 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (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 0 to Month 17
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Control Menjugate Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Control Menjugate Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations
Concentrations, given in µg/mL, were expressed as Geometric Mean Concentrations (GMCs).
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-19F, PRE | 0.4 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-9V, PIII(M3) | 5.8 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-6B, PRE | 0.1 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-18C, PIII(M3) | 7.2 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-14, PRE | 0.8 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-4, PIII(M3) | 7.7 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-18C, PRE | 0.1 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-14, PIII(M3) | 3.6 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-19F, PIII(M3) | 5.8 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-6B, PIII(M3) | 2.3 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-23F, PIII(M3) | 3.2 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-4, PRE | 0.1 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-9V, PRE | 0.1 µg/mL |
| SB692342 2 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-23F, PRE | 0.1 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-19F, PRE | 0.5 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-4, PRE | 0.1 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-4, PIII(M3) | 6.4 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-6B, PRE | 0.1 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-6B, PIII(M3) | 1.5 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-9V, PRE | 0.2 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-9V, PIII(M3) | 4.1 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-14, PRE | 1.1 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-14, PIII(M3) | 3.3 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-18C, PRE | 0.2 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-18C, PIII(M3) | 5.1 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-19F, PIII(M3) | 5.4 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-23F, PRE | 0.1 µg/mL |
| SB692342 1 Dose Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-23F, PIII(M3) | 3 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-23F, PRE | 0.1 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-18C, PIII(M3) | 6.1 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-9V, PRE | 0.1 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-6B, PIII(M3) | 1.5 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-19F, PRE | 0.3 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-6B, PRE | 0.1 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-4, PRE | 0 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-19F, PIII(M3) | 5.9 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-4, PIII(M3) | 8.1 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-14, PIII(M3) | 4.2 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-14, PRE | 0.7 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-23F, PIII(M3) | 3.8 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-18C, PRE | 0.1 µg/mL |
| Control Menjugate Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations | Anti-9V, PIII(M3) | 6 µg/mL |
Secondary
Anti-BPT Antibody Concentrations
Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs).
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Anti-BPT Antibody Concentrations | Anti-BPT, PRE | 7.7 EL.U/mL |
| SB692342 2 Dose Group | Anti-BPT Antibody Concentrations | Anti-BPT, PIII(M3) | 139.4 EL.U/mL |
| SB692342 1 Dose Group | Anti-BPT Antibody Concentrations | Anti-BPT, PRE | 7.6 EL.U/mL |
| SB692342 1 Dose Group | Anti-BPT Antibody Concentrations | Anti-BPT, PIII(M3) | 132.1 EL.U/mL |
| Control Menjugate Group | Anti-BPT Antibody Concentrations | Anti-BPT, PRE | 7.6 EL.U/mL |
| Control Menjugate Group | Anti-BPT Antibody Concentrations | Anti-BPT, PIII(M3) | 131.5 EL.U/mL |
Secondary
Anti-D, Anti-T Antibody Concentrations
Concentrations given in IU/mL, were expressed as Geometric Mean Concentrations (GMCs).
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Anti-D, Anti-T Antibody Concentrations | Anti-D, PIII(M3) | 2.1 IU/mL |
| SB692342 2 Dose Group | Anti-D, Anti-T Antibody Concentrations | Anti-T, PIII(M3) | 5.5 IU/mL |
| SB692342 2 Dose Group | Anti-D, Anti-T Antibody Concentrations | Anti-T, PRE | 0.6 IU/mL |
| SB692342 2 Dose Group | Anti-D, Anti-T Antibody Concentrations | Anti-D, PRE | 0.1 IU/mL |
| SB692342 1 Dose Group | Anti-D, Anti-T Antibody Concentrations | Anti-T, PRE | 1 IU/mL |
| SB692342 1 Dose Group | Anti-D, Anti-T Antibody Concentrations | Anti-T, PIII(M3) | 4.8 IU/mL |
| SB692342 1 Dose Group | Anti-D, Anti-T Antibody Concentrations | Anti-D, PIII(M3) | 2.4 IU/mL |
| SB692342 1 Dose Group | Anti-D, Anti-T Antibody Concentrations | Anti-D, PRE | 0.1 IU/mL |
| Control Menjugate Group | Anti-D, Anti-T Antibody Concentrations | Anti-T, PIII(M3) | 6.3 IU/mL |
| Control Menjugate Group | Anti-D, Anti-T Antibody Concentrations | Anti-D, PRE | 0.1 IU/mL |
| Control Menjugate Group | Anti-D, Anti-T Antibody Concentrations | Anti-T, PRE | 1 IU/mL |
| Control Menjugate Group | Anti-D, Anti-T Antibody Concentrations | Anti-D, PIII(M3) | 2.5 IU/mL |
Secondary
Anti-HB Antibody Concentrations
Concentrations given in mIU/mL were expressed as Geometric Mean Concentrations (GMCs).
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Anti-HB Antibody Concentrations | Anti-HB, PRE | 8.3 mIU/mL |
| SB692342 2 Dose Group | Anti-HB Antibody Concentrations | Anti-HB, PIII(M3) | 1725.5 mIU/mL |
| SB692342 1 Dose Group | Anti-HB Antibody Concentrations | Anti-HB, PRE | 10 mIU/mL |
| SB692342 1 Dose Group | Anti-HB Antibody Concentrations | Anti-HB, PIII(M3) | 1471.8 mIU/mL |
| Control Menjugate Group | Anti-HB Antibody Concentrations | Anti-HB, PRE | 9 mIU/mL |
| Control Menjugate Group | Anti-HB Antibody Concentrations | Anti-HB, PIII(M3) | 2153 mIU/mL |
Secondary
Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers
Concentrations given in titers were expressed as Geometric Mean Titers (GMTs).
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio1, PRE | 56.3 Titers |
| SB692342 2 Dose Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio1, PIII(M3) | 299.9 Titers |
| SB692342 2 Dose Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio2, PRE | 51.8 Titers |
| SB692342 2 Dose Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio2, PIII(M3) | 458.7 Titers |
| SB692342 2 Dose Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio3, PRE | 15.2 Titers |
| SB692342 2 Dose Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio3, PIII(M3) | 154.8 Titers |
| SB692342 1 Dose Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio3, PIII(M3) | 103.5 Titers |
| SB692342 1 Dose Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio1, PRE | 48.8 Titers |
| SB692342 1 Dose Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio2, PIII(M3) | 524.3 Titers |
| SB692342 1 Dose Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio3, PRE | 15.4 Titers |
| SB692342 1 Dose Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio1, PIII(M3) | 397.8 Titers |
| SB692342 1 Dose Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio2, PRE | 53.2 Titers |
| Control Menjugate Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio1, PIII(M3) | 573.1 Titers |
| Control Menjugate Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio2, PRE | 61.2 Titers |
| Control Menjugate Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio3, PIII(M3) | 123 Titers |
| Control Menjugate Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio2, PIII(M3) | 499.9 Titers |
| Control Menjugate Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio1, PRE | 103.8 Titers |
| Control Menjugate Group | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Anti-Polio3, PRE | 10.9 Titers |
Secondary
Anti-PRP Antibody Concentrations
Concentrations given in µg/mL were expressed as Geometric Mean Concentrations (GMCs).
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Anti-PRP Antibody Concentrations | Anti-PRP, PRE | 0.1 µg/mL |
| SB692342 2 Dose Group | Anti-PRP Antibody Concentrations | Anti-PRP, PIII(M3) | 28.2 µg/mL |
| SB692342 1 Dose Group | Anti-PRP Antibody Concentrations | Anti-PRP, PRE | 0.1 µg/mL |
| SB692342 1 Dose Group | Anti-PRP Antibody Concentrations | Anti-PRP, PIII(M3) | 30.3 µg/mL |
| Control Menjugate Group | Anti-PRP Antibody Concentrations | Anti-PRP, PRE | 0.1 µg/mL |
| Control Menjugate Group | Anti-PRP Antibody Concentrations | Anti-PRP, PIII(M3) | 31.2 µg/mL |
Secondary
Concentration of Antibodies Against M72 Antigen
Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs).
Time frame: Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)]
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, PRE | 1.4 EL.U/mL |
| SB692342 2 Dose Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M6 | 98.9 EL.U/mL |
| SB692342 2 Dose Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M12 | 68.3 EL.U/mL |
| SB692342 2 Dose Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M1 | 1275.2 EL.U/mL |
| SB692342 1 Dose Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, PRE | 1.4 EL.U/mL |
| SB692342 1 Dose Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M1 | 1264 EL.U/mL |
| SB692342 1 Dose Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M12 | 76 EL.U/mL |
| SB692342 1 Dose Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M6 | 102.6 EL.U/mL |
| Control Menjugate Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, PRE | 1.4 EL.U/mL |
| Control Menjugate Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M1 | 8 EL.U/mL |
| Control Menjugate Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M6 | 4.6 EL.U/mL |
| Control Menjugate Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M12 | 5.3 EL.U/mL |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M12 | 4.3 EL.U/mL |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, PRE | 1.4 EL.U/mL |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M1 | 7.4 EL.U/mL |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M6 | 4.9 EL.U/mL |
| Control Menjugate Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, PRE | 1.5 EL.U/mL |
| Control Menjugate Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M12 | 1.4 EL.U/mL |
| Control Menjugate Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M6 | 1.4 EL.U/mL |
| Control Menjugate Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M1 | 1.5 EL.U/mL |
| Control Tritanrix + Prevnar + Polio Sabin Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M12 | 1.5 EL.U/mL |
| Control Tritanrix + Prevnar + Polio Sabin Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, PRE | 1.4 EL.U/mL |
| Control Tritanrix + Prevnar + Polio Sabin Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M1 | 1.4 EL.U/mL |
| Control Tritanrix + Prevnar + Polio Sabin Group | Concentration of Antibodies Against M72 Antigen | Anti-M72, M6 | 1.4 EL.U/mL |
Secondary
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2),Interferon-gamma (INF-γ),Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L).
Time frame: Before vaccination (PRE)
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, PRE | 47 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), PRE | 14 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, PRE | 59.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), PRE | 5.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), PRE | 11.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, PRE | 42.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, PRE | 88 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), PRE | 12 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), PRE | 3 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), PRE | 28 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 14 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), PRE | 1.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, PRE | 44.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), PRE | 15 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), PRE | 20 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, PRE | 52 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), PRE | 1 T cells/million cells |
Secondary
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).
Time frame: Twelve Months post each dose (M12)
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M12 | 12.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 | 21 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M12 | 10.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M12 | 179 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 13 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M12 | 456.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M12 | 3.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 | 7 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 | 60 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 51 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M12 | 14.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M12 | 56.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 | 176 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M12 | 29 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M12 | 155 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 | 39 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 65 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M12 | 67 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 | 144 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 | 19 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M12 | 2 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 | 13 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M12 | 403 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 16 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M12 | 30 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M12 | 13 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 | 28 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M12 | 104 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M12 | 3 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 | 12 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M12 | 50 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M12 | 14 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 | 26 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M12 | 98 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 14 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M12 | 38 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M12 | 22 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M12 | 13 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M12 | 41 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M12 | 3 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 | 1 T cells/million cells |
Secondary
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).
Time frame: Six Months post each dose (M6)
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M6 | 310.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 | 31 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 | 72 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M6 | 12 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M6 | 16.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M6 | 19.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M6 | 68.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 | 18.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 | 223 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 63 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 13.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M6 | 19 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M6 | 633 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M6 | 14 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M6 | 40.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 13 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 | 86.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 | 26 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M6 | 171.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M6 | 512 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 65 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 | 202.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 | 15.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M6 | 65 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M6 | 27 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 12 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M6 | 107.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M6 | 35.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 | 28 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 | 12 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M6 | 13 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M6 | 2 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 | 17 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M6 | 107 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M6 | 48 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 | 5 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 16 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M6 | 10 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M6 | 39 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M6 | 12.5 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M6 | 41 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M6 | 13.5 T cells/million cells |
Secondary
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).
Time frame: One Month post each dose (M1)
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 52 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M1 | 640 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M1 | 431 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 | 57 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 | 14 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M1 | 51 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M1 | 109 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 28 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 | 95 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M1 | 15 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M1 | 54 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M1 | 14 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M1 | 53 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 | 142 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M1 | 71 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 | 127 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M1 | 51 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 20 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 50 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M1 | 51 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 | 195 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 | 24 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M1 | 859 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M1 | 138 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M1 | 449 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M1 | 17 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 | 63 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M1 | 14 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M1 | 24 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 | 30 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 | 28 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M1 | 9.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 | 19 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 17 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M1 | 115.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M1 | 19.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M1 | 27 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M1 | 173.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 | 24 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M1 | 235 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 25 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 | 56 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 | 12 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M1 | 28 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M1 | 12 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M1 | 16 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 12 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 | 15 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M1 | 127 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M1 | 19 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M1 | 11 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M1 | 31 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M1 | 3 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, M1 | 55.5 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M1 | 11 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 12 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M1 | 23 T cells/million cells |
Secondary
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).
Time frame: Seven Days post each dose (D7)
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 | 47 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 24 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), D7 | 25 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), D7 | 576 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 | 173 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 | 64 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), D7 | 52 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), D7 | 19 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 12 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, D7 | 499 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), D7 | 65 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), D7 | 232 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 | 25 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, D7 | 593.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 42.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 | 61.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 | 19.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), D7 | 82.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), D7 | 11 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), D7 | 36.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), D7 | 112 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 14.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 | 35.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 | 102 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), D7 | 493 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), D7 | 27.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), D7 | 160.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), D7 | 30 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, D7 | 128 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), D7 | 24 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), D7 | 138 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 | 22 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 | 3 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 | 12 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), D7 | 24 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 | 13 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), D7 | 40 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), D7 | 13 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), D7 | 21 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 | 22 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), D7 | 14 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), D7 | 26 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 | 12 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 16 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, D7 | 174 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), D7 | 11 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, D7 | 55 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), D7 | 9 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), D7 | 14 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 11.5 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4 all doubles, D7 | 52.5 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 | 1 T cells/million cells |
Secondary
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).
Time frame: Seven Days after each dose (D7)
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, D7 | 61 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),D7 | 34 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),D7 | 61 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),D7 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),D7 | 6 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),D7 | 37 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),D7 | 37 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, D7 | 55 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),D7 | 161.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),D7 | 7.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),D7 | 6 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, D7 | 43 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),D7 | 34 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, D7 | 46 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),D7 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, D7 | 11 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),D7 | 3 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),D7 | 123 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),D7 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, D7 | 11 T cells/million cells |
Secondary
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).
Time frame: Six Months after each dose (M6)
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M6 | 11 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M6 | 2 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M6 | 27.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M6 | 11 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M6 | 38 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M6 | 11 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M6 | 11 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M6 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M6 | 11 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M6 | 28 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M6 | 2 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M6 | 11 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M6 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M6 | 1 T cells/million cells |
Secondary
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).
Time frame: Twelve Months after each dose (M12)
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M12 | 11 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M12 | 14.5 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M12 | 1.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M12 | 11 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M12 | 16 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M12 | 11 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M12 | 11 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M12 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M12 | 11 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M12 | 11 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M12 | 15 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M12 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M12 | 11 T cells/million cells |
Secondary
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).
Time frame: Before vaccination (PRE)
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, PRE | 11 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),PRE | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),PRE | 8 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),PRE | 117 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, PRE | 40.5 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),PRE | 57 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, PRE | 11 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),PRE | 61 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, PRE | 11 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, PRE | 11 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),PRE | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),PRE | 53.5 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),PRE | 65 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, PRE | 11 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),PRE | 1 T cells/million cells |
Secondary
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).
Time frame: One Month after each dose (M1)
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M1 | 69 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M1 | 1 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M1 | 18 T cells/million cells |
| SB692342 2 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M1 | 82 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M1 | 142 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M1 | 12 T cells/million cells |
| SB692342 1 Dose Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M1 | 2.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M1 | 29.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M1 | 11 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M1 | 109 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M1 | 81 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M1 | 1 T cells/million cells |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M1 | 11 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M1 | 2.5 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Menjugate Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M1 | 4 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M1 | 86 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M1 | 1 T cells/million cells |
| Control Tritanrix + Prevnar + Polio Sabin Group | Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers | CD8 all doubles, M1 | 11 T cells/million cells |
Secondary
Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT)
A seropositive subject was a subject whose anti-BPT antibody concentration was ≥ 15 EL.U/mL.
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT) | Anti-BPT, PRE | 1 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT) | Anti-BPT, PIII(M3) | 44 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT) | Anti-BPT, PRE | 1 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT) | Anti-BPT, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT) | Anti-BPT, PRE | 1 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT) | Anti-BPT, PIII(M3) | 43 Participants |
Secondary
Number of Seropositive Subjects Against Hepatitis B (Anti-HB)
A seropositive subject was a subject whose anti-HB antibody concentration was ≥ 10 milli-international units per millilitre (mIU/mL).
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Hepatitis B (Anti-HB) | Anti-HB, PRE | 9 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Hepatitis B (Anti-HB) | Anti-HB, PIII(M3) | 42 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Hepatitis B (Anti-HB) | Anti-HB, PRE | 14 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Hepatitis B (Anti-HB) | Anti-HB, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Hepatitis B (Anti-HB) | Anti-HB, PRE | 13 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Hepatitis B (Anti-HB) | Anti-HB, PIII(M3) | 42 Participants |
Secondary
Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL
A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Following from this, the table shows data with titers ≥ 100 mIU/mL.
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL | Anti-HB, PRE | 2 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL | Anti-HB, PIII(M3) | 42 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL | Anti-HB, PRE | 2 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL | Anti-HB, PIII(M3) | 42 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL | Anti-HB, PRE | 2 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL | Anti-HB, PIII(M3) | 42 Participants |
Secondary
Number of Seropositive Subjects Against M72 Antigen
A seropositive subject was a subject whose M72 antibody concentration was greater than or equal to 2.8 ELISA units per millilitre (EL.U/mL).
Time frame: Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)]
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, PRE | 0 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M1 | 42 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M6 | 40 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M12 | 41 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M6 | 41 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M1 | 43 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, PRE | 0 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M12 | 42 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M12 | 35 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M6 | 32 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M1 | 39 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, PRE | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, PRE | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M12 | 31 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M1 | 39 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M6 | 35 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M6 | 0 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M12 | 1 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M1 | 1 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, PRE | 1 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M1 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M6 | 1 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, M12 | 2 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Seropositive Subjects Against M72 Antigen | Anti-M72, PRE | 0 Participants |
Secondary
Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3)
A seropositive subject was a subject whose anti-polio antibody titer was ≥ 1:8.
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio1, PRE | 36 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio1, PIII(M3) | 41 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio2, PRE | 33 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio2, PIII(M3) | 43 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio3, PRE | 21 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio3, PIII(M3) | 42 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio3, PIII(M3) | 38 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio1, PRE | 38 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio2, PIII(M3) | 42 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio3, PRE | 18 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio1, PIII(M3) | 43 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio2, PRE | 32 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio1, PIII(M3) | 42 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio2, PRE | 38 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio3, PIII(M3) | 39 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio2, PIII(M3) | 42 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio1, PRE | 39 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) | Anti-Polio3, PRE | 14 Participants |
Secondary
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F)
A seropositive subject was a subject whose anti-S pneumoniae antibody concentration was ≥ 0.05 µg/mL.
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-19F, PRE | 35 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-9V,PIII(M3) | 43 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-6B, PRE | 29 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-18C, PIII(M3) | 43 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-14, PRE | 39 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-4, PIII(M3) | 43 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-18C, PRE | 30 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-14, PIII(M3) | 44 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-19F, PIII(M3) | 44 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-6B, PIII(M3) | 44 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-23F, PIII(M3) | 43 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-4, PRE | 18 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-9V, PRE | 28 Participants |
| SB692342 2 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-23F, PRE | 25 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-19F, PRE | 37 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-4, PRE | 21 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-4, PIII(M3) | 43 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-6B, PRE | 27 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-6B, PIII(M3) | 41 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-9V, PRE | 33 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-9V,PIII(M3) | 43 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-14, PRE | 38 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-14, PIII(M3) | 44 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-18C, PRE | 35 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-18C, PIII(M3) | 44 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-19F, PIII(M3) | 44 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-23F, PRE | 30 Participants |
| SB692342 1 Dose Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-23F, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-23F, PRE | 26 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-18C, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-9V, PRE | 25 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-6B, PIII(M3) | 40 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-19F, PRE | 39 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-6B, PRE | 26 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-4, PRE | 12 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-19F, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-4, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-14, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-14, PRE | 38 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-23F, PIII(M3) | 42 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-18C, PRE | 26 Participants |
| Control Menjugate Group | Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) | Anti-9V,PIII(M3) | 43 Participants |
Secondary
Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T)
A seroprotected subject was a subject whose anti-diphtheria toxoid (anti-D)/anti-tetanus toxoid (anti-T) antibody concentration was ≥ 0.1 international-units per millilitre (IU/mL).
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Anti-D, PRE | 6 Participants |
| SB692342 2 Dose Group | Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Anti-D, PIII(M3) | 43 Participants |
| SB692342 2 Dose Group | Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Anti-T, PRE | 32 Participants |
| SB692342 2 Dose Group | Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Anti-T, PIII(M3) | 43 Participants |
| SB692342 1 Dose Group | Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Anti-T, PIII(M3) | 43 Participants |
| SB692342 1 Dose Group | Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Anti-D, PRE | 10 Participants |
| SB692342 1 Dose Group | Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Anti-T, PRE | 35 Participants |
| SB692342 1 Dose Group | Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Anti-D, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Anti-T, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Anti-D, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Anti-T, PRE | 35 Participants |
| Control Menjugate Group | Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) | Anti-D, PRE | 6 Participants |
Secondary
Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP)
A seroprotected subject was a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per millilitre (µg/mL).
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP) | Anti-PRP, PRE | 8 Participants |
| SB692342 2 Dose Group | Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP) | Anti-PRP, PIII(M3) | 44 Participants |
| SB692342 1 Dose Group | Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP) | Anti-PRP, PRE | 14 Participants |
| SB692342 1 Dose Group | Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP) | Anti-PRP, PIII(M3) | 44 Participants |
| Control Menjugate Group | Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP) | Anti-PRP, PRE | 12 Participants |
| Control Menjugate Group | Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP) | Anti-PRP, PIII(M3) | 43 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: Twelve Months post Dose 3 [PIII(M14)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), Normal | 38 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), Normal | 43 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), G1 | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), Normal | 44 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), G1 | 6 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), Normal | 42 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), Normal | 44 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), Missing | 7 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), G1 | 5 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), Missing | 4 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), Normal | 48 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), Normal | 46 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), Normal | 51 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), Normal | 51 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), Normal | 51 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), Normal | 42 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), Normal | 44 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), Missing | 4 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), Missing | 5 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), Normal | 44 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), Normal | 37 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), Missing | 5 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), G1 | 8 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), Normal | 43 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M14), Missing | 7 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M14), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M14), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M14), Missing | 4 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M14), G1 | 1 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: Six Months post Dose 3 [PIII(M13)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M13), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M13), Missing | 50 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M13), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M13), Normal | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M13), Normal | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M13), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M13), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M13), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M13), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M13), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M13), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M13), Missing | 50 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M13), Missing | 50 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M13), Normal | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M13), Normal | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M13), Missing | 50 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M13), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M13), Normal | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M13), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M13), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M13), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M13), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M13), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M13), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M13), Missing | 50 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M13), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M13), Normal | 43 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M13), G1 | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M13), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M13), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M13), Missing | 6 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M13), Normal | 44 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M13), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M13), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M13), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M13), Missing | 6 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M13), Normal | 44 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M13), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M13), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M13), Missing | 6 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M13), Normal | 42 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M13), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M13), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M13), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M13), Missing | 6 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M13), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M13), Missing | 8 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M13), Normal | 44 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M13), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M13), G2 | 0 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: Twelve Months post Dose 1 [PI(M12)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M12), Normal | 47 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M12), G1 | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M12), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M12), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M12), Missing | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M12), Normal | 48 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M12), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M12), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M12), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M12), Missing | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M12), Normal | 48 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M12), G1 | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M12), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M12), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M12), Missing | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M12), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M12), G1 | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M12), G2 | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M12), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M12), Missing | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M12), Normal | 49 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M12), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M12), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M12), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M12), Missing | 1 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: Twelve Months post Dose 2 [PII(M13)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M13), Missing | 4 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M13), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M13), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M13), Normal | 45 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M13), Normal | 41 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M13), G1 | 4 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M13), G2 | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M13), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M13), Missing | 4 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M13), Normal | 43 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M13), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M13), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M13), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M13), Missing | 7 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M13), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M13), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M13), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M13), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M13), Missing | 4 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M13), G1 | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M13), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M13), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M13), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M13), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M13), Missing | 4 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M13), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M13), Missing | 50 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M13), Normal | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M13), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M13), Missing | 50 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M13), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M13), Missing | 50 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M13), Missing | 50 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M13), Normal | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M13), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M13), Normal | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M13), Normal | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M13), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M13), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M13), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M13), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M13), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M13), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M13), Missing | 50 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M13), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M13), Normal | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M13), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M13), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M13), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M13), G2 | 0 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were : normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: Seven days post Dose 1 [PI(D7)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), Missing | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), Normal | 48 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), Missing | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), Normal | 49 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), Missing | 4 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), Normal | 49 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), Missing | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), Missing | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), Normal | 48 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), Missing | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), Normal | 48 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), Missing | 3 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), Missing | 2 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), Normal | 48 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), Normal | 47 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), Normal | 49 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), Missing | 2 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), Normal | 48 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), Missing | 2 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), G1 | 1 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), Missing | 1 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), Normal | 48 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(D7), Missing | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), Normal | 45 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(D7), Missing | 5 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), Normal | 47 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), G1 | 1 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(D7), Missing | 1 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), Normal | 48 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(D7), Missing | 2 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), Normal | 49 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(D7), G4 | 0 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: Seven days post Dose 2 [PII(D37)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), Missing | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), Missing | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), Normal | 48 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), Normal | 47 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), Normal | 42 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), Missing | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), Missing | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), Normal | 48 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G1 | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), Missing | 8 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), Normal | 47 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G1 | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), Missing | 4 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), Normal | 46 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), Missing | 3 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), Normal | 44 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), Normal | 45 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), Missing | 5 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), Normal | 45 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), Missing | 3 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), Normal | 46 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), Missing | 4 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), Missing | 52 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), Normal | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), Missing | 52 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), Normal | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), Missing | 52 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), Missing | 52 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), Normal | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), Normal | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), Normal | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), Missing | 52 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), Missing | 2 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), Normal | 48 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), Normal | 47 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G1 | 1 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G2 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G4 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), Normal | 44 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G1 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G2 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G4 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), Missing | 6 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G1 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G2 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G4 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), Missing | 2 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), Normal | 48 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G1 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G2 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G4 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), Missing | 2 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), Normal | 48 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G1 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G2 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G4 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), Missing | 2 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), Missing | 2 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), Normal | 47 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(D37), Normal | 47 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), Missing | 5 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), Normal | 47 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), Missing | 2 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(D37), Normal | 44 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(D37), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), Missing | 2 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), Normal | 47 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(D37), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(D37), Missing | 2 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: Seven days post Dose 3 [PIII(D67)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), Normal | 44 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), Missing | 3 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), Missing | 3 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), Missing | 3 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), Missing | 3 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), Normal | 51 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), Normal | 51 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), Missing | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), Normal | 51 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), Normal | 49 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), Missing | 3 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), G1 | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), Normal | 52 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), Missing | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), Normal | 45 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), Missing | 3 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), Normal | 46 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), Normal | 45 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), Missing | 4 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(D67), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), Missing | 3 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(D67), Normal | 46 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(D67), Normal | 46 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(D67), Missing | 3 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(D67), Missing | 4 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: One Month post Dose 1 [PI(M1)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), Missing | 50 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), Normal | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), Normal | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), Missing | 50 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), Missing | 50 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), Normal | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), Normal | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), Normal | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), Missing | 50 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), Missing | 50 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), Normal | 42 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), G1 | 2 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), Missing | 3 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), Normal | 46 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), Missing | 4 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), Normal | 47 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), Missing | 3 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), Normal | 45 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), Missing | 8 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), Normal | 42 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), Missing | 8 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), Normal | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), Normal | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), Missing | 50 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), Missing | 50 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), Missing | 50 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), Normal | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), Normal | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M1), Missing | 50 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), Missing | 50 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M1), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M1), Normal | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M1), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M1), G2 | 0 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: One Month post Dose 2 [PII(M2)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M2), Missing | 3 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M2), Normal | 42 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M2), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M2), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M2), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M2), Missing | 8 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M2), Normal | 42 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M2), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M2), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M2), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M2), Missing | 8 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M2), Normal | 47 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M2), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M2), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M2), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M2), Missing | 3 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M2), Normal | 45 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M2), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M2), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M2), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M2), Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M2), Normal | 47 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M2), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M2), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M2), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M2), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M2), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M2), Normal | 36 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M2), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M2), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M2), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M2), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M2), Missing | 9 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M2), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M2), Missing | 6 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M2), Missing | 14 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M2), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M2), Normal | 36 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M2), Normal | 41 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M2), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M2), Normal | 44 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M2), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M2), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M2), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M2), Missing | 6 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M2), Missing | 14 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M2), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M2), Normal | 44 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M2), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M2), G1 | 0 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: One Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), Missing | 4 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), Missing | 3 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), Missing | 3 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), Missing | 3 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), Normal | 45 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), Missing | 3 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), Normal | 50 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), Normal | 49 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), Missing | 3 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), Normal | 48 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), Missing | 4 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), Normal | 48 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), Missing | 3 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), Missing | 2 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), Normal | 50 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), Missing | 2 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), Normal | 44 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), Normal | 43 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), Missing | 5 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), Missing | 5 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), Missing | 5 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), Normal | 44 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M3), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), Missing | 5 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M3), Normal | 44 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), Missing | 6 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M3), Normal | 44 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M3), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M3), G2 | 0 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were : normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: Six Months post Dose 1 [PI(M6)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M6), Missing | 4 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M6), Normal | 45 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M6), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M6), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M6), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PI(M6), Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M6), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M6), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M6), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M6), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PI(M6), Missing | 4 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M6), Normal | 45 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M6), G1 | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M6), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M6), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PI(M6), Missing | 4 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M6), Normal | 46 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M6), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M6), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M6), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PI(M6), Missing | 4 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M6), Normal | 41 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M6), G1 | 4 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M6), G2 | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PI(M6), G4 | 0 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: Six Months post Dose 2 [PII(M7)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M7), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M7), Normal | 42 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M7), G1 | 3 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M7), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M7), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M7), Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M7), Normal | 42 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M7), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M7), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M7), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M7), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M7), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M7), Missing | 7 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M7), Normal | 43 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M7), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M7), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M7), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M7), Missing | 7 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M7), Missing | 8 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M7), Normal | 45 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M7), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M7), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M7), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M7), Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M7), Normal | 43 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M7), Normal | 44 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M7), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M7), Normal | 43 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M7), Normal | 41 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M7), Normal | 43 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M7), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M7), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M7), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M7), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M7), Missing | 6 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M7), Missing | 6 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M7), Normal | 44 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M7), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M7), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M7), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M7), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PII(M7), Missing | 7 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M7), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PII(M7), G1 | 3 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M7), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M7), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PII(M7), Missing | 6 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M7), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PII(M7), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PII(M7), Missing | 7 Participants |
Secondary
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.
Time frame: Six Months post Dose 3 [PIII(M8)]
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), Missing | 8 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), G1 | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), Normal | 44 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), Normal | 41 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), Normal | 43 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), Missing | 6 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), Normal | 43 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), G1 | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), Normal | 43 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), Normal | 47 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), Normal | 51 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), G1 | 4 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), G1 | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), Missing | 5 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), Normal | 47 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), Normal | 50 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), Normal | 50 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), Missing | 3 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), Missing | 8 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), Normal | 46 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), Normal | 44 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), G1 | 2 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | Haem, PIII(M8), Missing | 3 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | PLA, PIII(M8), Missing | 3 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), Normal | 46 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | ALA, PIII(M8), Missing | 3 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), Normal | 46 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | CREA, PIII(M8), G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers | WBC, PIII(M8), Normal | 41 Participants |
Secondary
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers
Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, G1, G2 and G4 . Values that did not fall under normal levels or assessed grades were missing.
Time frame: Before vaccination (PRE)
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, Normal | 48 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, Missing | 8 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, Missing | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, Normal | 42 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, Normal | 42 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, Missing | 8 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G2 | 1 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G1 | 2 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, Missing | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G4 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, Normal | 49 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, Missing | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G2 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G1 | 0 Participants |
| SB692342 2 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, Normal | 45 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, Normal | 48 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, Normal | 48 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, Normal | 48 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, Missing | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G1 | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, Normal | 49 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, Normal | 47 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G1 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G4 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, Missing | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G1 | 1 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G2 | 0 Participants |
| SB692342 1 Dose Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, Missing | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, Normal | 39 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, Missing | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, Missing | 11 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, Missing | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, Normal | 49 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, Normal | 50 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, Normal | 39 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, Missing | 1 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, Missing | 11 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, Normal | 49 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G2 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G4 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G2 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G1 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, Normal | 52 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G2 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, Normal | 52 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, Missing | 1 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G1 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, Missing | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G4 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, Normal | 51 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G4 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G4 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G2 | 1 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G1 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G1 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G2 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G1 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G4 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, Normal | 51 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, Missing | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, Normal | 51 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G2 | 0 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, Missing | 1 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, Missing | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G1 | 1 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, Normal | 48 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, Missing | 1 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G1 | 1 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, Missing | 1 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, Normal | 43 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, Missing | 7 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, Normal | 40 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, Normal | 48 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G2 | 1 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, Missing | 9 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, Normal | 41 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G1 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G2 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G4 | 0 Participants |
| Control Menjugate Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, Missing | 9 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, Normal | 49 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G1 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G2 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, Normal | 49 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, Normal | 48 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, Normal | 49 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G1 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, Missing | 2 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G4 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G2 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, G1 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, G4 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G2 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | WBC, PRE, Normal | 47 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, Missing | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G4 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G2 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, Missing | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | CREA, PRE, G4 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | Haem, PRE, G1 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, Missing | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G4 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G2 | 0 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | ALA, PRE, G1 | 1 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers | PLA, PRE, Missing | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (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 Day 0 up to 12 months post last vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| SB692342 1 Dose Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Control Menjugate Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Control Menjugate Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| Control Tritanrix + Prevnar + Polio Sabin Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter
A seroconverted subject is a vaccinated subject with at least a four fold increased antibody titer post vaccination.
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-19F, PRE | 30 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-9V, PIII(M3) | 43 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-6B, PRE | 8 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-18C, PIII(M3) | 43 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-14, PRE | 34 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-4, PIII(M3) | 43 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-18C, PRE | 10 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-14, PIII(M3) | 44 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-19F, PIII(M3) | 43 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-6B, PIII(M3) | 38 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-23F, PIII(M3) | 42 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-4, PRE | 5 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-9V, PRE | 18 Participants |
| SB692342 2 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-23F, PRE | 9 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-19F, PRE | 30 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-4, PRE | 10 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-4, PIII(M3) | 43 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-6B, PRE | 5 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-6B, PIII(M3) | 40 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-9V, PRE | 20 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-9V, PIII(M3) | 43 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-14, PRE | 33 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-14, PIII(M3) | 43 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-18C, PRE | 17 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-18C, PIII(M3) | 43 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-19F, PIII(M3) | 44 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-23F, PRE | 11 Participants |
| SB692342 1 Dose Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-23F, PIII(M3) | 41 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-23F, PRE | 14 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-18C, PIII(M3) | 42 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-9V, PRE | 10 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-6B, PIII(M3) | 35 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-19F, PRE | 26 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-6B, PRE | 6 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-4, PRE | 2 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-19F, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-4, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-14, PIII(M3) | 43 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-14, PRE | 33 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-23F, PIII(M3) | 42 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-18C, PRE | 9 Participants |
| Control Menjugate Group | Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter | Anti-9V, PIII(M3) | 43 Participants |