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CompletedNCT01098474Updated Jun 27, 2019Results posted

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

A Phase 2 interventional study of GSK's investigational vaccine 692342 and Tritanrix™ HB+Hib in Tuberculosis, sponsored by GlaxoSmithKline. Completed at 1 site in Gambia. Open to participants aged 2 Months to 7 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-27.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
301
Allocation
Randomized
Ages
2 Months to 7 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Tuberculosis

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Keywords

  • Tuberculosis vaccine
03

In context

Tuberculosis

1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.

This study's enrollment of 301 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 7 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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 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

Exclusion Criteria:

  • Child in care
  • Acute or chronic, 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 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 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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
301 participants (actual)

Study arms

  • Experimental
    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.

    Biological: GSK's investigational vaccine 692342

  • Experimental
    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.

    Biological: GSK's investigational vaccine 692342

  • Active comparator
    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.

    Biological: Menjugate™

  • Experimental
    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.

    Biological: GSK's investigational vaccine 692342 · Biological: Tritanrix™ HB+Hib · Biological: Prevnar™ · Biological: Polio Sabin™

  • Experimental
    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.

    Biological: GSK's investigational vaccine 692342 · Biological: Tritanrix™ HB+Hib · Biological: Prevnar™ · Biological: Polio Sabin™

  • Active comparator
    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.

    Biological: Tritanrix™ HB+Hib · Biological: Prevnar™ · Biological: Polio Sabin™

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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]

  17. 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

  18. 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]

  19. 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

  20. 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

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

    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)

  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

    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)

  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

    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)

  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

    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)

  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

    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)

  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

    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)

  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

    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)

  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

    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)

  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

    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)

  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

    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)

  11. 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)]

  12. 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)]

  13. 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)]

  14. 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)]

  15. 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)]

  16. 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)]

  17. 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)]

  18. 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)]

  19. 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)]

  20. 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)]

  21. 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)]

  22. 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)]

  23. 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)]

  24. 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)]

  25. 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)]

  26. 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)]

  27. 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

  28. 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)

  29. 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)]

  30. 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)]

  31. 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)]

  32. 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)]

  33. 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)]

  34. 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)]

  35. 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)]

  36. 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)]

  37. 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)]

  38. 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)]

  39. 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)]

  40. 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)]

  41. 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)]

07

Results

Posted Nov 27, 2018

Participant flow

Active Phase
Participant flow — Active Phase
MilestoneSB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Started505050495249
Completed484945495249
Not completed215000
Withdrew: Other003000
Withdrew: Withdrawal by subject112000
Withdrew: Lost to follow-up100000
Follow Up Phase
Participant flow — Follow Up Phase
MilestoneSB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Started484945495249
Completed484945475044
Not completed000225
Withdrew: Travelled out of study area000010
Withdrew: Other000004
Withdrew: Withdrawal by subject000201
Withdrew: Lost to follow-up000010

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses
ParticipantsSB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate Group
Grade 3 Pain, Dose 1000
Grade 3 Swelling, Dose 1000
Grade 3 Pain, Dose 2000
Grade 3 Swelling, Dose 2000
Grade 3 Pain, Across doses000
Grade 3 Swelling, Across doses000
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses.
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Grade 3 Pain, Dose 2000
Grade 3 Swelling, Dose 2202
Grade 3 Pain, Dose 3200
Grade 3 Swelling, Dose 3363
Grade 3 Pain, Across doses200
Grade 3 Swelling, Across doses365
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses.
ParticipantsSB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate Group
Grade 3 Drowsiness, Dose 1000
Grade 3 Irritability, Dose 1000
Grade 3 Loss of appetite, Dose 1000
Grade 3 Temperature /Axillary, Dose 1000
Grade 3 Drowsiness, Dose 2000
Grade 3 Irritability, Dose 2000
Grade 3 Loss of appetite, Dose 2000
Grade 3 Temperature/Axillary, Dose 2001
Grade 3 Drowsiness, Across doses000
Grade 3 Irritability, Across doses000
Grade 3 Loss of appetite, Across doses000
Grade 3 Temperature/Axillary, Across doses001
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses.
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Grade 3 Drowsiness, Dose 2000
Grade 3 Irritability, Dose 2000
Grade 3 Loss of appetite, Dose 2000
Grade 3 Temperature/Axillary, Dose 2000
Grade 3 Drowsiness, Dose 3000
Grade 3 Irritability, Dose 3200
Grade 3 Loss of appetite, Dose 3000
Grade 3 Temperature/Axillary, Dose 3000
Grade 3 Drowsiness, Across doses000
Grade 3 Irritability, Across doses200
Grade 3 Loss of appetite, Across doses000
Grade 3 Temperature/Axillary, Across doses000
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs)
ParticipantsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs)282527142622
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Serious Adverse Events (SAEs)
ParticipantsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
Number of Subjects With Serious Adverse Events (SAEs)010010
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
Haem, PRE, Grade 3000000
WBC, PRE, Grade 3000000
PLA, PRE, Grade 3000000
ALA, PRE, Grade 3000000
CREA, PRE, Grade 3000000
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate Group
Haem Grade 3000
WBC Grade 3000
PLA Grade 3000
ALA Grade 3000
CREA Grade 3000
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
Haem Grade 300000
WBC Grade 300000
PLA Grade 300000
ALA Grade 300000
CREA Grade 300000
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Haem Grade 3000
WBC Grade 3000
PLA Grade 3000
ALA Grade 3000
CREA Grade 3000
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate Group
Haem Grade 3000
WBC Grade 3000
PLA Grade 3000
ALA Grade 3000
CREA Grade 3000
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692342 2 Dose GroupControl Menjugate Group
Haem Grade 300
WBC Grade 300
PLA Grade 300
ALA Grade 300
CREA Grade 300
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Haem Grade 3000
WBC Grade 3000
PLA Grade 3000
ALA Grade 3000
CREA Grade 3000
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692342 1 Dose Group
Haem Grade 30
WBC Grade 30
PLA Grade 30
ALA Grade 30
CREA Grade 30
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692342 2 Dose GroupControl Menjugate Group
Haem Grade 300
WBC Grade 300
PLA Grade 300
ALA Grade 300
CREA Grade 300
PrimaryNumber 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]
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692342 2 Dose GroupControl Menjugate Group
Haem Grade 300
WBC Grade 300
PLA Grade 300
ALA Grade 300
CREA Grade 300
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692342 2 Dose Group
Haem Grade 30
WBC Grade 30
PLA Grade 30
ALA Grade 30
CREA Grade 30
PrimaryNumber 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]
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692342 2 Dose GroupControl Menjugate Group
Haem Grade 300
WBC Grade 300
PLA Grade 300
ALA Grade 300
CREA Grade 300
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Haem Grade 3000
WBC Grade 3000
PLA Grade 3001
ALA Grade 3000
CREA Grade 3000
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Haem Grade 3000
WBC Grade 3000
PLA Grade 3000
ALA Grade 3010
CREA Grade 3000
SecondaryFrequency of 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)
Reported as:
Median · T cells/million cells
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
T cells/million cellsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
CD4 all doubles, PRE47 (23 to 87)59.5 (30.5 to 125)42.5 (22 to 71)88 (27 to 181)44.5 (11 to 65)52 (33 to 149)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE1 (1 to 1)1 (1 to 24.5)1 (1 to 12)14 (1 to 53)1 (1 to 15)1 (1 to 30)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE1 (1 to 12)1 (1 to 12)1 (1 to 1)1 (1 to 17)1 (1 to 1)1 (1 to 14)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 13)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), PRE1 (1 to 11)1 (1 to 13)1 (1 to 1)1 (1 to 15)1 (1 to 1)1 (1 to 13)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), PRE14 (1 to 51)1 (1 to 28)11.5 (1 to 41)3 (1 to 62)1 (1 to 16)1 (1 to 52)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE1 (1 to 12)1 (1 to 24)1 (1 to 12)1 (1 to 27)1 (1 to 1)1 (1 to 27)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE1 (1 to 12)1 (1 to 6)1 (1 to 12)1 (1 to 1)1 (1 to 11)1 (1 to 16)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE1 (1 to 1)1 (1 to 11.5)1 (1 to 1)1 (1 to 20)1 (1 to 1)1 (1 to 15)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), PRE1 (1 to 38)5.5 (1 to 29.5)1 (1 to 40)28 (1 to 63)1 (1 to 40)20 (1 to 62)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), PRE1 (1 to 1)1 (1 to 12.5)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), PRE1 (1 to 11)1 (1 to 27.5)1 (1 to 19)1 (1 to 11)1.5 (1 to 14)1 (1 to 21)
CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), PRE1 (1 to 11)1 (1 to 21.5)1 (1 to 13)12 (1 to 47)1 (1 to 22)15 (1 to 49)
SecondaryFrequency of 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)
Reported as:
Median · T cells/million cells
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
T cells/million cellsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
CD4 all doubles, D7499 (250 to 1267)593.5 (269 to 1094)128 (83 to 379)174 (67 to 321)55 (33 to 81)52.5 (33 to 85)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D724 (1 to 83)42.5 (14 to 66)1 (1 to 39)16 (1 to 43)1 (1 to 15)1 (1 to 19)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), D747 (15 to 143)61.5 (18 to 157)12 (1 to 25)12 (1 to 29)1 (1 to 12)1 (1 to 1)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), D725 (1 to 103)19.5 (1 to 71)1 (1 to 26)13 (1 to 38)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), D765 (12 to 286)82.5 (29 to 320)24 (1 to 52)14 (1 to 44)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), D71 (1 to 15)1 (1 to 22)1 (1 to 1)1 (1 to 12)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), D71 (1 to 32)11 (1 to 38)1 (1 to 11)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), D719 (9 to 61)36.5 (1 to 105)1 (1 to 19)13 (1 to 49)1 (1 to 1)1 (1 to 13)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), D752 (1 to 144)112 (25 to 297)24 (1 to 102)21 (1 to 58)9 (1 to 63)1 (1 to 37)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), D712 (1 to 32)14.5 (1 to 45)1 (1 to 24)1 (1 to 21)1 (1 to 12)11.5 (1 to 15.5)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), D764 (12 to 107)35.5 (1 to 88)3 (1 to 24)1 (1 to 13)1 (1 to 13)1 (1 to 7.5)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), D7173 (38 to 232)102 (31 to 237)22 (1 to 86)22 (1 to 67)1 (1 to 1)1 (1 to 14.5)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), D7576 (245 to 1126)493 (309 to 960)138 (42 to 208)26 (1 to 134)1 (1 to 45)1 (1 to 42.5)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), D71 (1 to 18)1 (1 to 36)1 (1 to 11)1 (1 to 13)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), D725 (10 to 58)27.5 (5 to 85)1 (1 to 28)1 (1 to 20)11 (1 to 21)1 (1 to 13.5)
CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), D7232 (85 to 444)160.5 (61 to 314)30 (5 to 69)40 (12 to 91)1 (1 to 17)14 (1 to 44.5)
SecondaryFrequency of 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)
Reported as:
Median · T cells/million cells
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
T cells/million cellsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
CD4 all doubles, M1640 (403 to 1200)859 (348 to 1950)173.5 (93.5 to 476)235 (142 to 485)31 (22 to 66)55.5 (30 to 115)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M152 (1 to 157)50 (12 to 253)17 (1 to 63)25 (1 to 88)1 (1 to 12)12 (1 to 26)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M1142 (48 to 300)195 (66 to 408)30 (11.5 to 82.5)56 (14 to 88)1 (1 to 12)1 (1 to 17)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M114 (1 to 45)24 (1 to 132)1 (1 to 14)12 (1 to 26)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M1109 (49 to 143)138 (56 to 327)27 (1 to 59)28 (12 to 63)1 (1 to 1)1 (1 to 12)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M11 (1 to 19)17 (1 to 37)1 (1 to 1)1 (1 to 12)1 (1 to 1)1 (1 to 11)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M115 (1 to 44)14 (1 to 63)1 (1 to 6)1 (1 to 1)1 (1 to 1)1 (1 to 12)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M114 (1 to 41)24 (1 to 64)1 (1 to 12)12 (1 to 24)1 (1 to 1)1 (1 to 14)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M151 (1 to 107)51 (1 to 162)1 (1 to 50.5)16 (1 to 96)1 (1 to 42)1 (1 to 42)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M128 (1 to 109)20 (1 to 60)1 (1 to 45)12 (1 to 24)1 (1 to 1)1 (1 to 15)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M195 (32 to 251)127 (63 to 257)28 (1 to 59.5)15 (1 to 78)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M157 (26 to 204)63 (27 to 118)19 (1 to 76)24 (1 to 44)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M1431 (239 to 838)449 (253 to 793)115.5 (42.5 to 277.5)127 (36 to 257)3 (1 to 33)23 (1 to 66)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M11 (1 to 27)1 (1 to 29)1 (1 to 7)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M153 (5 to 106)51 (3 to 108)9.5 (1 to 38)19 (1 to 58)1 (1 to 15)11 (1 to 35)
CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M154 (18 to 107)71 (25 to 141)19.5 (1 to 49)11 (1 to 48)1 (1 to 14)1 (1 to 21)
SecondaryFrequency of 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)
Reported as:
Median · T cells/million cells
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
T cells/million cellsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
CD4 all doubles, M6633 (324 to 1062)512 (318.5 to 992.5)107.5 (47 to 184)107 (72 to 191)39 (23 to 71)41 (23 to 73.5)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M663 (18.5 to 129)65 (13 to 125)12 (1 to 28)16 (1 to 48)1 (1 to 13)1 (1 to 13.5)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M6223 (78 to 403)202.5 (101.5 to 434)28 (1 to 50)17 (1 to 64)1 (1 to 15)1 (1 to 12.5)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M618.5 (1 to 25.5)15.5 (1 to 29)1 (1 to 1)1 (1 to 13)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M668.5 (40.5 to 163)65 (34.5 to 184.5)1 (1 to 22)13 (1 to 41)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M61 (1 to 1)1 (1 to 13)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M612 (1 to 20.5)1 (1 to 26)1 (1 to 11)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M61 (1 to 6.5)1 (1 to 28)1 (1 to 1)1 (1 to 1)1 (1 to 11)1 (1 to 13)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M616.5 (1 to 71)40.5 (1 to 95.5)1 (1 to 28)2 (1 to 44)1 (1 to 39)13.5 (1 to 48.5)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M613.5 (1 to 59.5)13 (1 to 52.5)1 (1 to 14)1 (1 to 17)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M672 (38 to 206.5)86.5 (27 to 156.5)12 (1 to 28)5 (1 to 40)1 (1 to 13)1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M631 (1 to 84.5)26 (7 to 55)1 (1 to 13)1 (1 to 16)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M6310.5 (60 to 591.5)171.5 (126.5 to 369)35.5 (1 to 68)48 (8 to 99)10 (1 to 27)12.5 (1 to 41)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M61 (1 to 18)1 (1 to 13)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M619 (1 to 71.5)27 (1 to 61)1 (1 to 12)1 (1 to 14)1 (1 to 14)1 (1 to 13.5)
CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M619.5 (1 to 58)14 (1 to 46.5)1 (1 to 14)1 (1 to 16)1 (1 to 18)1 (1 to 14)
SecondaryFrequency of 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)
Reported as:
Median · T cells/million cells
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
T cells/million cellsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
CD4 all doubles, M12456.5 (237 to 1062)403 (245 to 745)104 (59 to 201)98 (52 to 157)38 (22 to 61)41 (22 to 79)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1251 (18 to 145)65 (18 to 99)16 (1 to 42)14 (1 to 48)1 (1 to 1)1 (1 to 14)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M12176 (73 to 424)144 (80 to 329)28 (12 to 52)26 (13 to 47)1 (1 to 14)1 (1 to 12)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M127 (1 to 39)13 (1 to 40)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M1256.5 (24 to 145)67 (24 to 149)13 (1 to 21)1 (1 to 16)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M121 (1 to 13)1 (1 to 13)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M1212.5 (1 to 37)1 (1 to 23)1 (1 to 1)1 (1 to 13)1 (1 to 1)1 (1 to 12)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M121 (1 to 12)1 (1 to 17)1 (1 to 13)1 (1 to 1)1 (1 to 12)1 (1 to 13)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M1210.5 (1 to 57)29 (1 to 81)1 (1 to 48)14 (1 to 67)22 (1 to 58)13 (1 to 72)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M1213 (1 to 29)1 (1 to 17)1 (1 to 16)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M1260 (15 to 138)39 (13 to 91)12 (1 to 21)1 (1 to 12)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M1221 (1 to 56)19 (1 to 40)1 (1 to 12)1 (1 to 12)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M12179 (84 to 283)155 (74 to 300)30 (1 to 66)50 (22 to 87)1 (1 to 20)3 (1 to 25)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M121 (1 to 15)1 (1 to 12)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M123.5 (1 to 38)1 (1 to 35)3 (1 to 40)1 (1 to 39)1 (1 to 27)1 (1 to 19)
CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M1214.5 (1 to 49)2 (1 to 54)1 (1 to 25)1 (1 to 25)1 (1 to 27)1 (1 to 41)
SecondaryFrequency of 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)
Reported as:
Median · T cells/million cells
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
T cells/million cellsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
CD8 all doubles, PRE11 (11 to 81)40.5 (11 to 70.5)11 (11 to 61)11 (11 to 93)11 (11 to 65)11 (11 to 47)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),PRE1 (1 to 44)1 (1 to 42)1 (1 to 53)1 (1 to 46)1 (1 to 50)1 (1 to 55)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),PRE8 (1 to 116)117 (40 to 260)57 (1 to 138)61 (1 to 166)53.5 (1 to 91)65 (1 to 302)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),PRE1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),PRE1 (1 to 64)1 (1 to 14.5)1 (1 to 1)1 (1 to 1)1 (1 to 28)1 (1 to 27)
CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),PRE1 (1 to 40)1 (1 to 1)1 (1 to 23)1 (1 to 1)1 (1 to 2)1 (1 to 43)
SecondaryFrequency of 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)
Reported as:
Median · T cells/million cells
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
T cells/million cellsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
CD8 all doubles, D761 (11 to 147)55 (11 to 161)43 (11 to 101)46 (11 to 82)11 (11 to 11)11 (11 to 28)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D71 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),D71 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),D71 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),D71 (1 to 1)1 (1 to 31)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),D71 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),D71 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),D71 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),D734 (1 to 104)37 (1 to 119)6 (1 to 116)1 (1 to 100)3 (1 to 54)1 (1 to 25)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),D71 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),D71 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),D71 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),D761 (1 to 185)161.5 (1 to 574)1 (1 to 107)34 (1 to 303)1 (1 to 61)123 (1 to 289.5)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),D71 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),D76 (1 to 64)7.5 (1 to 72)1 (1 to 67)1 (1 to 10)1 (1 to 85)1 (1 to 48)
CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),D737 (1 to 89)1 (1 to 50)1 (1 to 70)1 (1 to 31)1 (1 to 30)1 (1 to 2.5)
SecondaryFrequency of 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)
Reported as:
Median · T cells/million cells
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
T cells/million cellsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
CD8 all doubles, M169 (11 to 145)82 (11 to 163)29.5 (11 to 80)81 (26 to 139)11 (11 to 28)11 (11 to 53)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M11 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M11 (1 to 1)1 (1 to 32)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M11 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M11 (1 to 1)1 (1 to 32)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M11 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M11 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M11 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 56)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M11 (1 to 55)1 (1 to 46)1 (1 to 52)11 (1 to 99)2.5 (1 to 85)4 (1 to 109)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M11 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M11 (1 to 12)1 (1 to 28)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M11 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M11 (1 to 139)142 (1 to 308)2.5 (1 to 116)109 (2 to 218)1 (1 to 48)86 (1 to 330)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M11 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M118 (1 to 87)12 (1 to 111)1 (1 to 50)1 (1 to 90)1 (1 to 51)1 (1 to 35)
CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M11 (1 to 65)1 (1 to 65)1 (1 to 5.5)1 (1 to 64)1 (1 to 5)1 (1 to 1)
SecondaryFrequency of 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)
Reported as:
Median · T cells/million cells
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
T cells/million cellsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
CD8 all doubles, M611 (11 to 53)11 (11 to 20)11 (11 to 32)11 (11 to 11)11 (11 to 29)11 (11 to 11)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M61 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M61 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M61 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M61 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M61 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M61 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M61 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M61 (1 to 25.5)2 (1 to 65)1 (1 to 44)1 (1 to 63)1 (1 to 52)2 (1 to 59)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M61 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M61 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M61 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M61 (1 to 29.5)27.5 (1 to 60)38 (1 to 91)1 (1 to 56)28 (1 to 67)1 (1 to 43.5)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M61 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M61 (1 to 54.5)1 (1 to 55.5)1 (1 to 3)1 (1 to 60)1 (1 to 36)1 (1 to 49)
CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M61 (1 to 33)1 (1 to 36.5)1 (1 to 1)1 (1 to 40)1 (1 to 1)1 (1 to 1)
SecondaryFrequency of 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)
Reported as:
Median · T cells/million cells
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
T cells/million cellsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
CD8 all doubles, M1211 (11 to 52)11 (11 to 35)11 (11 to 38)11 (11 to 41)11 (11 to 41)11 (11 to 42)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M121 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M121 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M121 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M121 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M121 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M121 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M121 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M121 (1 to 29)1 (1 to 64)1 (1 to 68)1 (1 to 35)1 (1 to 32)1 (1 to 40)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M121 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M121 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M121 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M1214.5 (1 to 92)16 (1 to 77)1 (1 to 59)1 (1 to 35)1 (1 to 57)15 (1 to 66)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M121 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 5)1 (1 to 1)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M121 (1 to 34)1 (1 to 50)1 (1 to 58)1 (1 to 65)1 (1 to 117)1 (1 to 22)
CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M121.5 (1 to 67)1 (1 to 48)1 (1 to 25)1 (1 to 128)11 (1 to 57)1 (1 to 33)
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Seropositive Subjects Against M72 Antigen
ParticipantsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-M72, PRE000010
Anti-M72, M14243393910
Anti-M72, M64041323501
Anti-M72, M124142353112
SecondaryConcentration 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)]
Reported as:
Geometric mean · EL.U/mL
Concentration of Antibodies Against M72 Antigen
EL.U/mLSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-M72, PRE1.4 (1.4 to 1.4)1.4 (1.4 to 1.4)1.4 (1.4 to 1.4)1.4 (1.4 to 1.4)1.5 (1.3 to 1.7)1.4 (1.4 to 1.4)
Anti-M72, M11275.2 (981.3 to 1657.2)1264 (928 to 1721.5)8 (6 to 10.7)7.4 (5.3 to 10.2)1.5 (1.3 to 1.7)1.4 (1.4 to 1.4)
Anti-M72, M698.9 (75.2 to 130.1)102.6 (78.7 to 133.9)4.6 (3.4 to 6.2)4.9 (3.8 to 6.4)1.4 (1.4 to 1.4)1.4 (1.4 to 1.5)
Anti-M72, M1268.3 (50.7 to 92)76 (56.6 to 102)5.3 (3.9 to 7)4.3 (3.2 to 5.8)1.4 (1.4 to 1.5)1.5 (1.4 to 1.7)
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T)
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-D, PRE6106
Anti-D, PIII(M3)434343
Anti-T, PRE323535
Anti-T, PIII(M3)434343
SecondaryAnti-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)]
Reported as:
Geometric mean · IU/mL
Anti-D, Anti-T Antibody Concentrations
IU/mLSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-D, PRE0.1 (0.1 to 0.1)0.1 (0.1 to 0.1)0.1 (0.1 to 0.1)
Anti-D, PIII(M3)2.1 (1.6 to 2.7)2.4 (1.8 to 3.1)2.5 (2 to 3.1)
Anti-T, PRE0.6 (0.4 to 1)1 (0.6 to 1.5)1 (0.6 to 1.6)
Anti-T, PIII(M3)5.5 (4.3 to 7.1)4.8 (3.6 to 6.4)6.3 (4.8 to 8.3)
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP)
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-PRP, PRE81412
Anti-PRP, PIII(M3)444443
SecondaryAnti-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)]
Reported as:
Geometric mean · µg/mL
Anti-PRP Antibody Concentrations
µg/mLSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-PRP, PRE0.1 (0.1 to 0.1)0.1 (0.1 to 0.2)0.1 (0.1 to 0.2)
Anti-PRP, PIII(M3)28.2 (20.3 to 39.1)30.3 (21.8 to 42.1)31.2 (21.8 to 44.7)
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT)
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-BPT, PRE111
Anti-BPT, PIII(M3)444343
SecondaryAnti-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)]
Reported as:
Geometric mean · EL.U/mL
Anti-BPT Antibody Concentrations
EL.U/mLSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-BPT, PRE7.7 (7.3 to 8)7.6 (7.4 to 7.9)7.6 (7.4 to 7.9)
Anti-BPT, PIII(M3)139.4 (117.7 to 164.9)132.1 (116.6 to 149.5)131.5 (113.5 to 152.5)
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Seropositive Subjects Against Hepatitis B (Anti-HB)
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-HB, PRE91413
Anti-HB, PIII(M3)424342
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-HB, PRE222
Anti-HB, PIII(M3)424242
SecondaryAnti-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)]
Reported as:
Geometric mean · mIU/mL
Anti-HB Antibody Concentrations
mIU/mLSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-HB, PRE8.3 (6 to 11.4)10 (7.1 to 14)9 (6.7 to 12.2)
Anti-HB, PIII(M3)1725.5 (1045 to 2849)1471.8 (947.5 to 2286)2153 (1468.2 to 3157.4)
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3)
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-Polio1, PRE363839
Anti-Polio1, PIII(M3)414342
Anti-Polio2, PRE333238
Anti-Polio2, PIII(M3)434242
Anti-Polio3, PRE211814
Anti-Polio3, PIII(M3)423839
SecondaryAnti-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)]
Reported as:
Geometric mean · Titers
Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers
TitersSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-Polio1, PRE56.3 (30.7 to 103.2)48.8 (27.3 to 87.5)103.8 (58.1 to 185.3)
Anti-Polio1, PIII(M3)299.9 (167.6 to 536.7)397.8 (240.2 to 658.8)573.1 (368.7 to 890.6)
Anti-Polio2, PRE51.8 (28.8 to 93.2)53.2 (28 to 101)61.2 (34.8 to 107.8)
Anti-Polio2, PIII(M3)458.7 (307.7 to 683.7)524.3 (331.1 to 830.3)499.9 (317.7 to 786.5)
Anti-Polio3, PRE15.2 (9 to 25.6)15.4 (8.6 to 27.6)10.9 (6.7 to 17.9)
Anti-Polio3, PIII(M3)154.8 (100.8 to 237.8)103.5 (59.7 to 179.6)123 (73.6 to 205.8)
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F)
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-4, PRE182112
Anti-4, PIII(M3)434343
Anti-6B, PRE292726
Anti-6B, PIII(M3)444140
Anti-9V, PRE283325
Anti-9V,PIII(M3)434343
Anti-14, PRE393838
Anti-14, PIII(M3)444443
Anti-18C, PRE303526
Anti-18C, PIII(M3)434443
Anti-19F, PRE353739
Anti-19F, PIII(M3)444443
Anti-23F, PRE253026
Anti-23F, PIII(M3)434342
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-4, PRE5102
Anti-4, PIII(M3)434343
Anti-6B, PRE856
Anti-6B, PIII(M3)384035
Anti-9V, PRE182010
Anti-9V, PIII(M3)434343
Anti-14, PRE343333
Anti-14, PIII(M3)444343
Anti-18C, PRE10179
Anti-18C, PIII(M3)434342
Anti-19F, PRE303026
Anti-19F, PIII(M3)434443
Anti-23F, PRE91114
Anti-23F, PIII(M3)424142
SecondaryAnti-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)]
Reported as:
Geometric mean · µg/mL
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations
µg/mLSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Anti-4, PRE0.1 (0 to 0.1)0.1 (0.1 to 0.1)0 (0 to 0)
Anti-4, PIII(M3)7.7 (6.2 to 9.7)6.4 (5.3 to 7.8)8.1 (6.5 to 10)
Anti-6B, PRE0.1 (0.1 to 0.1)0.1 (0.1 to 0.1)0.1 (0.1 to 0.1)
Anti-6B, PIII(M3)2.3 (1.4 to 3.8)1.5 (0.9 to 2.4)1.5 (0.8 to 2.7)
Anti-9V, PRE0.1 (0.1 to 0.1)0.2 (0.1 to 0.3)0.1 (0.1 to 0.1)
Anti-9V, PIII(M3)5.8 (4.4 to 7.7)4.1 (3 to 5.6)6 (4.5 to 8.1)
Anti-14, PRE0.8 (0.6 to 1.2)1.1 (0.7 to 1.6)0.7 (0.4 to 1)
Anti-14, PIII(M3)3.6 (2.5 to 5.3)3.3 (2.3 to 4.7)4.2 (2.8 to 6.2)
Anti-18C, PRE0.1 (0.1 to 0.1)0.2 (0.1 to 0.2)0.1 (0.1 to 0.1)
Anti-18C, PIII(M3)7.2 (5.7 to 9)5.1 (3.8 to 7)6.1 (4.2 to 8.8)
Anti-19F, PRE0.4 (0.3 to 0.6)0.5 (0.3 to 0.7)0.3 (0.2 to 0.5)
Anti-19F, PIII(M3)5.8 (4.1 to 8.2)5.4 (4.2 to 6.9)5.9 (4.5 to 7.5)
Anti-23F, PRE0.1 (0.1 to 0.1)0.1 (0.1 to 0.1)0.1 (0.1 to 0.1)
Anti-23F, PIII(M3)3.2 (2.1 to 4.8)3 (2 to 4.6)3.8 (2.5 to 5.7)
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Serious Adverse Events (SAEs)
ParticipantsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
Number of Subjects With Serious Adverse Events (SAEs)213131
SecondaryNumber 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)
Reported as:
Count of participants · Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers
ParticipantsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692342 1 Dose GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
Haem, PRE, Normal494850514849
Haem, PRE, G1010010
Haem, PRE, G2100100
Haem, PRE, G4000000
Haem, PRE, Missing000010
WBC, PRE, Normal454849524347
WBC, PRE, G1000000
WBC, PRE, G2000000
WBC, PRE, G4000000
WBC, PRE, Missing511072
PLA, PRE, Normal484949524849
PLA, PRE, G1200010
PLA, PRE, G2000000
PLA, PRE, G4000000
PLA, PRE, Missing000010
ALA, PRE, Normal424739514048
ALA, PRE, G1010001
ALA, PRE, G2000010
ALA, PRE, G4000000
ALA, PRE, Missing8111190
CREA, PRE, Normal424839514149
CREA, PRE, G1000000
CREA, PRE, G2000000
CREA, PRE, G4000000
CREA, PRE, Missing8111190
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate Group
Haem, PI(D7), Normal494848
Haem, PI(D7), G1000
Haem, PI(D7), G2000
Haem, PI(D7), G4000
Haem, PI(D7), Missing120
WBC, PI(D7), Normal464745
WBC, PI(D7), G1000
WBC, PI(D7), G2000
WBC, PI(D7), G4000
WBC, PI(D7), Missing435
PLA, PI(D7), Normal494947
PLA, PI(D7), G1011
PLA, PI(D7), G2000
PLA, PI(D7), G4000
PLA, PI(D7), Missing001
ALA, PI(D7), Normal484848
ALA, PI(D7), G1000
ALA, PI(D7), G2000
ALA, PI(D7), G4000
ALA, PI(D7), Missing222
CREA, PI(D7), Normal484849
CREA, PI(D7), G1000
CREA, PI(D7), G2000
CREA, PI(D7), G4000
CREA, PI(D7), Missing221
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692342 2 Dose GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Menjugate GroupControl Tritanrix + Prevnar + Polio Sabin Group
Haem, PII(D37), Normal474504747
Haem, PII(D37), G110010
Haem, PII(D37), G200000
Haem, PII(D37), G400000
Haem, PII(D37), Missing245222
WBC, PII(D37), Normal424404444
WBC, PII(D37), G100000
WBC, PII(D37), G200000
WBC, PII(D37), G400000
WBC, PII(D37), Missing855265
PLA, PII(D37), Normal474504847
PLA, PII(D37), G110000
PLA, PII(D37), G200000
PLA, PII(D37), G400000
PLA, PII(D37), Missing245222
ALA, PII(D37), Normal484604847
ALA, PII(D37), G100000
ALA, PII(D37), G200000
ALA, PII(D37), G400000
ALA, PII(D37), Missing235222
CREA, PII(D37), Normal484604847
CREA, PII(D37), G100000
CREA, PII(D37), G200000
CREA, PII(D37), G400000
CREA, PII(D37), Missing235222
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Haem, PIII(D67), Normal465146
Haem, PIII(D67), G1000
Haem, PIII(D67), G2000
Haem, PIII(D67), G4000
Haem, PIII(D67), Missing313
WBC, PIII(D67), Normal444946
WBC, PIII(D67), G1000
WBC, PIII(D67), G2000
WBC, PIII(D67), G4000
WBC, PIII(D67), Missing533
PLA, PIII(D67), Normal465146
PLA, PIII(D67), G1000
PLA, PIII(D67), G2000
PLA, PIII(D67), G4000
PLA, PIII(D67), Missing313
ALA, PIII(D67), Normal465145
ALA, PIII(D67), G1010
ALA, PIII(D67), G2000
ALA, PIII(D67), G4000
ALA, PIII(D67), Missing304
CREA, PIII(D67), Normal465245
CREA, PIII(D67), G1000
CREA, PIII(D67), G2000
CREA, PIII(D67), G4000
CREA, PIII(D67), Missing304
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate Group
Haem, PI(M1), Normal0450
Haem, PI(M1), G1020
Haem, PI(M1), G2000
Haem, PI(M1), G4000
Haem, PI(M1), Missing50350
WBC, PI(M1), Normal0460
WBC, PI(M1), G1000
WBC, PI(M1), G2000
WBC, PI(M1), G4000
WBC, PI(M1), Missing50450
PLA, PI(M1), Normal0470
PLA, PI(M1), G1000
PLA, PI(M1), G2000
PLA, PI(M1), G4000
PLA, PI(M1), Missing50350
ALA, PI(M1), Normal0420
ALA, PI(M1), G1000
ALA, PI(M1), G2000
ALA, PI(M1), G4000
ALA, PI(M1), Missing50850
CREA, PI(M1), Normal0420
CREA, PI(M1), G1000
CREA, PI(M1), G2000
CREA, PI(M1), G4000
CREA, PI(M1), Missing50850
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692342 2 Dose GroupControl Menjugate Group
Haem, PII(M2), Normal4744
Haem, PII(M2), G100
Haem, PII(M2), G200
Haem, PII(M2), G400
Haem, PII(M2), Missing36
WBC, PII(M2), Normal4541
WBC, PII(M2), G100
WBC, PII(M2), G200
WBC, PII(M2), G400
WBC, PII(M2), Missing59
PLA, PII(M2), Normal4744
PLA, PII(M2), G100
PLA, PII(M2), G200
PLA, PII(M2), G400
PLA, PII(M2), Missing36
ALA, PII(M2), Normal4236
ALA, PII(M2), G100
ALA, PII(M2), G200
ALA, PII(M2), G400
ALA, PII(M2), Missing814
CREA, PII(M2), Normal4236
CREA, PII(M2), G100
CREA, PII(M2), G200
CREA, PII(M2), G400
CREA, PII(M2), Missing814
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Haem, PIII(M3), Normal464944
Haem, PIII(M3), G1000
Haem, PIII(M3), G2000
Haem, PIII(M3), G4000
Haem, PIII(M3), Missing335
WBC, PIII(M3), Normal454843
WBC, PIII(M3), G1000
WBC, PIII(M3), G2000
WBC, PIII(M3), G4000
WBC, PIII(M3), Missing446
PLA, PIII(M3), Normal464844
PLA, PIII(M3), G1000
PLA, PIII(M3), G2000
PLA, PIII(M3), G4000
PLA, PIII(M3), Missing335
ALA, PIII(M3), Normal465044
ALA, PIII(M3), G1000
ALA, PIII(M3), G2000
ALA, PIII(M3), G4000
ALA, PIII(M3), Missing325
CREA, PIII(M3), Normal465044
CREA, PIII(M3), G1000
CREA, PIII(M3), G2000
CREA, PIII(M3), G4000
CREA, PIII(M3), Missing325
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692342 1 Dose Group
Haem, PI(M6), Normal41
Haem, PI(M6), G14
Haem, PI(M6), G21
Haem, PI(M6), G40
Haem, PI(M6), Missing4
WBC, PI(M6), Normal45
WBC, PI(M6), G10
WBC, PI(M6), G20
WBC, PI(M6), G40
WBC, PI(M6), Missing5
PLA, PI(M6), Normal46
PLA, PI(M6), G10
PLA, PI(M6), G20
PLA, PI(M6), G40
PLA, PI(M6), Missing4
ALA, PI(M6), Normal45
ALA, PI(M6), G11
ALA, PI(M6), G20
ALA, PI(M6), G40
ALA, PI(M6), Missing4
CREA, PI(M6), Normal46
CREA, PI(M6), G10
CREA, PI(M6), G20
CREA, PI(M6), G40
CREA, PI(M6), Missing4
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692342 2 Dose GroupControl Menjugate Group
Haem, PII(M7), Normal4241
Haem, PII(M7), G133
Haem, PII(M7), G200
Haem, PII(M7), G400
Haem, PII(M7), Missing56
WBC, PII(M7), Normal4244
WBC, PII(M7), G100
WBC, PII(M7), G200
WBC, PII(M7), G400
WBC, PII(M7), Missing86
PLA, PII(M7), Normal4544
PLA, PII(M7), G100
PLA, PII(M7), G200
PLA, PII(M7), G400
PLA, PII(M7), Missing56
ALA, PII(M7), Normal4343
ALA, PII(M7), G100
ALA, PII(M7), G200
ALA, PII(M7), G400
ALA, PII(M7), Missing77
CREA, PII(M7), Normal4343
CREA, PII(M7), G100
CREA, PII(M7), G200
CREA, PII(M7), G400
CREA, PII(M7), Missing77
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Haem, PIII(M8), Normal434744
Haem, PIII(M8), G1142
Haem, PIII(M8), G2000
Haem, PIII(M8), G4000
Haem, PIII(M8), Missing513
WBC, PIII(M8), Normal414741
WBC, PIII(M8), G1000
WBC, PIII(M8), G2000
WBC, PIII(M8), G4000
WBC, PIII(M8), Missing858
PLA, PIII(M8), Normal445046
PLA, PIII(M8), G1010
PLA, PIII(M8), G2000
PLA, PIII(M8), G4000
PLA, PIII(M8), Missing513
ALA, PIII(M8), Normal435046
ALA, PIII(M8), G1100
ALA, PIII(M8), G2000
ALA, PIII(M8), G4000
ALA, PIII(M8), Missing513
CREA, PIII(M8), Normal435146
CREA, PIII(M8), G1000
CREA, PIII(M8), G2000
CREA, PIII(M8), G4000
CREA, PIII(M8), Missing613
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692342 2 Dose GroupControl Menjugate Group
Haem, PIII(M13), Normal043
Haem, PIII(M13), G101
Haem, PIII(M13), G200
Haem, PIII(M13), G400
Haem, PIII(M13), Missing506
WBC, PIII(M13), Normal042
WBC, PIII(M13), G100
WBC, PIII(M13), G200
WBC, PIII(M13), G400
WBC, PIII(M13), Missing508
PLA, PIII(M13), Normal044
PLA, PIII(M13), G100
PLA, PIII(M13), G200
PLA, PIII(M13), G400
PLA, PIII(M13), Missing506
ALA, PIII(M13), Normal044
ALA, PIII(M13), G100
ALA, PIII(M13), G200
ALA, PIII(M13), G400
ALA, PIII(M13), Missing506
CREA, PIII(M13), Normal044
CREA, PIII(M13), G100
CREA, PIII(M13), G200
CREA, PIII(M13), G400
CREA, PIII(M13), Missing506
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692342 1 Dose Group
Haem, PI(M12), Normal47
Haem, PI(M12), G12
Haem, PI(M12), G20
Haem, PI(M12), G40
Haem, PI(M12), Missing1
WBC, PI(M12), Normal48
WBC, PI(M12), G10
WBC, PI(M12), G20
WBC, PI(M12), G40
WBC, PI(M12), Missing2
PLA, PI(M12), Normal48
PLA, PI(M12), G11
PLA, PI(M12), G20
PLA, PI(M12), G40
PLA, PI(M12), Missing1
ALA, PI(M12), Normal46
ALA, PI(M12), G12
ALA, PI(M12), G21
ALA, PI(M12), G40
ALA, PI(M12), Missing1
CREA, PI(M12), Normal49
CREA, PI(M12), G10
CREA, PI(M12), G20
CREA, PI(M12), G40
CREA, PI(M12), Missing1
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692342 2 Dose GroupControl Menjugate Group
Haem, PII(M13), Normal410
Haem, PII(M13), G140
Haem, PII(M13), G210
Haem, PII(M13), G400
Haem, PII(M13), Missing450
WBC, PII(M13), Normal430
WBC, PII(M13), G100
WBC, PII(M13), G200
WBC, PII(M13), G400
WBC, PII(M13), Missing750
PLA, PII(M13), Normal460
PLA, PII(M13), G100
PLA, PII(M13), G200
PLA, PII(M13), G400
PLA, PII(M13), Missing450
ALA, PII(M13), Normal450
ALA, PII(M13), G110
ALA, PII(M13), G200
ALA, PII(M13), G400
ALA, PII(M13), Missing450
CREA, PII(M13), Normal460
CREA, PII(M13), G100
CREA, PII(M13), G200
CREA, PII(M13), G400
CREA, PII(M13), Missing450
SecondaryNumber 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)]
Reported as:
Count of participants · Participants
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
ParticipantsSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Haem, PIII(M14), Normal384637
Haem, PIII(M14), G1658
Haem, PIII(M14), G2000
Haem, PIII(M14), G4000
Haem, PIII(M14), Missing514
WBC, PIII(M14), Normal424842
WBC, PIII(M14), G1000
WBC, PIII(M14), G2000
WBC, PIII(M14), G4000
WBC, PIII(M14), Missing747
PLA, PIII(M14), Normal445144
PLA, PIII(M14), G1000
PLA, PIII(M14), G2000
PLA, PIII(M14), G4000
PLA, PIII(M14), Missing514
ALA, PIII(M14), Normal435143
ALA, PIII(M14), G1101
ALA, PIII(M14), G2000
ALA, PIII(M14), G4000
ALA, PIII(M14), Missing515
CREA, PIII(M14), Normal445144
CREA, PIII(M14), G1000
CREA, PIII(M14), G2000
CREA, PIII(M14), G4000
CREA, PIII(M14), Missing515

Adverse events

Collected over Solicited symptoms: during the 7-day post-vaccination period; Unsolicited AEs: during the 30-day post-vaccination period; SAEs: from study start (Day 0) up to one month post-vaccination and from Day 0 up to 12 months post last vaccination.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SB692342 2 Dose Group0/50 (0%)2/50 (4%)33/50 (66%)
SB692342 1 Dose Group0/50 (0%)3/50 (6%)22/50 (44%)
Control Menjugate Group1/50 (2%)3/50 (6%)31/50 (62%)
SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group0/49 (0%)1/49 (2%)34/49 (69.4%)
SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group0/52 (0%)1/52 (1.9%)22/52 (42.3%)
Control Tritanrix + Prevnar + Polio Sabin Group0/49 (0%)1/49 (2%)26/49 (53.1%)
Most frequent serious events
Most frequent serious events
EventSB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
BronchopneumoniaInfections and infestations2/501/501/500/490/520/49
SepsisInfections and infestations0/500/501/500/490/521/49
GastroenteritisInfections and infestations1/501/500/501/490/520/49
Thermal burnInjury, poisoning and procedural complications0/501/500/500/490/520/49
PyrexiaGeneral disorders0/500/501/500/490/520/49
RashSkin and subcutaneous tissue disorders0/500/501/500/490/520/49
Cerebral malariaInfections and infestations0/500/501/500/490/520/49
MalariaInfections and infestations1/500/500/500/490/520/49
Febrile convulsionNervous system disorders0/500/500/500/491/520/49
Most frequent other events
Most frequent other events
EventSB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin Group
Respiratory tract infectionInfections and infestations21/5014/5019/5015/499/5214/49
Temperature (Axillary)General disorders19/505/5013/5018/499/5212/49
PainGeneral disorders6/502/506/5010/4913/5213/49
SwellingGeneral disorders0/500/500/506/498/528/49
IrritabilityGeneral disorders3/500/502/508/495/524/49
DiarrhoeaGastrointestinal disorders8/505/502/505/491/523/49
PyrexiaGeneral disorders3/501/504/500/492/520/49
ConjunctivitisEye disorders0/500/501/500/490/523/49
DrowsinessGeneral disorders2/500/501/503/493/520/49
Loss of appetiteGeneral disorders3/500/501/503/492/520/49

Baseline characteristics

Age, Continuous
Age, Continuous(Months)SB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin GroupTotal
Mean5.8 ± 0.685.7 ± 0.615.7 ± 0.652.1 ± 0.282 ± 0.192.1 ± 0.313.9 ± 1.9
Sex: Female, Male
Sex: Female, Male(Participants)SB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin GroupTotal
Female342023251623141
Male163027243626159
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)SB692342 2 Dose GroupSB692342 1 Dose GroupControl Menjugate GroupSB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin GroupSB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin GroupControl Tritanrix + Prevnar + Polio Sabin GroupTotal
African heritage/African American505050495249300
08

Study locations

1 site
  • GSK Investigational Site
    Banjul, Gambia
09

References and documents

Publications

  • Idoko OT, Owolabi OA, Owiafe PK, Moris P, Odutola A, Bollaerts A, Ogundare E, Jongert E, Demoitie MA, Ofori-Anyinam O, Ota MO. Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine when given as a booster to BCG in Gambian infants: an open-label randomized controlled trial. Tuberculosis (Edinb). 2014 Dec;94(6):564-78. doi: 10.1016/j.tube.2014.07.001. Epub 2014 Aug 9. PubMed 25305000 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01098474
Lead sponsor
GlaxoSmithKline
Collaborators
Aeras
Responsible party
Sponsor
First posted
Apr 2, 2010
Start date
Jul 7, 2010
Primary completion
Apr 30, 2011
Completion
Mar 16, 2012
Results posted
Nov 27, 2018
Last update
Jun 27, 2019

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Heptavalent Pneumococcal Conjugate Vaccine · Poliovirus Vaccine, Oral

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