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Completed

NCT Number: NCT01098474

Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

2 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site

Banjul, The Gambia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK's investigational vaccine 692342

Biological

Intramuscular, 1 or 2 doses

Tritanrix™ HB+Hib

Biological

Intramuscular, 3 doses

Prevnar™

Biological

Intramuscular, 3 doses

Polio Sabin™

Biological

Oral, 3 doses

Menjugate™

Biological

Intramuscular, 3 doses

Primary outcomes

  1. Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses

    Time frame: 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.

  2. Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses.

    Time frame: 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.

  3. Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses.

    Time frame: 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.

  4. Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses.

    Time frame: 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.

  5. Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs)

    Time frame: 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.

  6. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: 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.

  7. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  8. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  9. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  10. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  11. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  12. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  13. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  14. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  15. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  16. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  17. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  18. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  19. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

  20. Number of Subjects With Grade 3 Haematological and Biochemical Levels

    Time frame: 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.

Secondary outcomes

  1. Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers

    Time frame: 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).

  2. Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers

    Time frame: Seven Days post each dose (D7)

    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).

  3. Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers

    Time frame: One Month post each dose (M1)

    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).

  4. Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers

    Time frame: Six Months post each dose (M6)

    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).

  5. Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers

    Time frame: Twelve Months post each dose (M12)

    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).

  6. Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers

    Time frame: 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).

  7. Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers

    Time frame: Seven Days after each dose (D7)

    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).

  8. Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers

    Time frame: One Month after each dose (M1)

    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).

  9. Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers

    Time frame: Six Months after each dose (M6)

    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).

  10. Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers

    Time frame: Twelve Months after each dose (M12)

    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).

  11. Number of Seropositive Subjects Against M72 Antigen

    Time frame: 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).

  12. Concentration of Antibodies Against M72 Antigen

    Time frame: 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).

  13. Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T)

    Time frame: 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).

  14. Anti-D, Anti-T Antibody Concentrations

    Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

    Concentrations given in IU/mL, were expressed as Geometric Mean Concentrations (GMCs).

  15. Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP)

    Time frame: 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).

  16. Anti-PRP Antibody Concentrations

    Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

    Concentrations given in µg/mL were expressed as Geometric Mean Concentrations (GMCs).

  17. Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT)

    Time frame: 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.

  18. Anti-BPT Antibody Concentrations

    Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

    Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs).

  19. Number of Seropositive Subjects Against Hepatitis B (Anti-HB)

    Time frame: 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).

  20. Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL

    Time frame: 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.

  21. Anti-HB Antibody Concentrations

    Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

    Concentrations given in mIU/mL were expressed as Geometric Mean Concentrations (GMCs).

  22. Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3)

    Time frame: 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.

  23. Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers

    Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

    Concentrations given in titers were expressed as Geometric Mean Titers (GMTs).

  24. Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F)

    Time frame: 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.

  25. Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter

    Time frame: 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.

  26. Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations

    Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

    Concentrations, given in µg/mL, were expressed as Geometric Mean Concentrations (GMCs).

  27. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: 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.

  28. Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers

    Time frame: 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.

  29. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: 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.

  30. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: Seven days post Dose 2 [PII(D37)]

    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.

  31. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: Seven days post Dose 3 [PIII(D67)]

    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.

  32. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: One Month post Dose 1 [PI(M1)]

    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.

  33. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: One Month post Dose 2 [PII(M2)]

    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.

  34. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: One Month post Dose 3 [PIII(M3)]

    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.

  35. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: Six Months post Dose 1 [PI(M6)]

    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.

  36. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: Six Months post Dose 2 [PII(M7)]

    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.

  37. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: Six Months post Dose 3 [PIII(M8)]

    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.

  38. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: Six Months post Dose 3 [PIII(M13)]

    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.

  39. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: Twelve Months post Dose 1 [PI(M12)]

    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.

  40. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: Twelve Months post Dose 2 [PII(M13)]

    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.

  41. Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers

    Time frame: Twelve Months post Dose 3 [PIII(M14)]

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Aeras

Registry information

Official study title

Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy Infants

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Apr 2, 2010
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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