Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: GSK's investigational vaccine 692342 (Biological)
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.
干预措施: GSK's investigational vaccine 692342 (Biological)
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.
干预措施: Menjugate™ (Biological)
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.
干预措施: Prevnar™ (Biological)
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.
干预措施: GSK's investigational vaccine 692342 (Biological)
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.
干预措施: Tritanrix™ HB+Hib (Biological)
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.
干预措施: Polio Sabin™ (Biological)
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.
干预措施: GSK's investigational vaccine 692342 (Biological)
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.
干预措施: Tritanrix™ HB+Hib (Biological)
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.
干预措施: Prevnar™ (Biological)
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.
干预措施: Polio Sabin™ (Biological)
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.
干预措施: Tritanrix™ HB+Hib (Biological)
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.
干预措施: Prevnar™ (Biological)
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.
干预措施: Polio Sabin™ (Biological)
结局指标
主要结局
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses
时间窗: 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.
时间窗: 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.
时间窗: 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 Serious Adverse Events (SAEs)
时间窗: 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 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses.
时间窗: 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)
时间窗: 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 Grade 3 Haematological and Biochemical Levels
时间窗: At Month 8
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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: At Day 7
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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: At Day 37
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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: At Day 67
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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: At Month 1
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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: At Month 2
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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: At Month 3
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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: At Month 6
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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: At Month 7
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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: Six Months post Dose 3 [At Month 13]
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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: At Month 12
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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: Twelve Months post Dose 2 [At Month 13]
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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
时间窗: At Month 14
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.
次要结局
- Anti-D, Anti-T Antibody Concentrations(Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)])
- 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)])
- Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT)(Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)])
- Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3)(Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)])
- 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)])
- Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP)(Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)])
- Anti-HB Antibody Concentrations(Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)])
- Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers(Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)])
- Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers(Twelve Months post each dose (M12))
- 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)])
- Anti-BPT Antibody Concentrations(Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)])
- Number of Subjects With Serious Adverse Events (SAEs)(From Day 0 up to 12 months post last vaccination)
- Anti-PRP Antibody Concentrations(Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)])
- 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)])
- Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter(Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)])
- Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers(Before vaccination (PRE))
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(Twelve Months post Dose 3 [PIII(M14)])
- Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers(Twelve Months after each dose (M12))
- Number of Seropositive Subjects Against Hepatitis B (Anti-HB)(Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)])
- 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)])
- 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)])
- Frequency of 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))
- Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers(Seven Days post each dose (D7))
- Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers(One Month post each dose (M1))
- Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers(Six Months post each dose (M6))
- Frequency of 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))
- Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers(Seven Days after each dose (D7))
- Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers(One Month after each dose (M1))
- Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers(Six Months after each dose (M6))
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(Seven days post Dose 1 [PI(D7)])
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(Seven days post Dose 2 [PII(D37)])
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(Seven days post Dose 3 [PIII(D67)])
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(One Month post Dose 1 [PI(M1)])
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(One Month post Dose 2 [PII(M2)])
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(One Month post Dose 3 [PIII(M3)])
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(Six Months post Dose 1 [PI(M6)])
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(Six Months post Dose 2 [PII(M7)])
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(Six Months post Dose 3 [PIII(M8)])
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(Six Months post Dose 3 [PIII(M13)])
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(Twelve Months post Dose 1 [PI(M12)])
- Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers(Twelve Months post Dose 2 [PII(M13)])