TuberculosisPhase 2NCT01098474
Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants
A Phase 2 study testing GSK's investigational vaccine 692342, Tritanrix™ HB+Hib and Prevnar™ in people with Tuberculosis, run by GlaxoSmithKline at 1 site in The Gambia.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- GSK's investigational vaccine 692342, Tritanrix™ HB+Hib and Prevnar™
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteThe Gambia
- Study dates
- 7 Jul 2010to 16 Mar 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative (LAR(s)) can and will comply with the requirements of the protocol.
- Written or oral, signed or thumb-printed and witnessed informed consent obtained from the subject's parent(s)/LAR(s).
- Subjects who received their birth dose of Bacille Calmette Guerrin.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- For the 'Outside Expanded Programme on Immunisation' cohort:
- Must have documented evidence that he/she has completed the primary Expanded Programme on Immunisation regimen at least 1 month prior to planned vaccination with investigational vaccination regimen.
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- Aged between 5 and 7 months at the time of the first study vaccination.
- For the 'Within EPI' cohort:
- Must have received the birth dose of Bacille Calmette Guerrin, oral polio vaccine and Hepatitis B vaccine but NO further Expanded Programme on Immunisation vaccines.
- Aged between 2 and 4 months at the time of the first study vaccination with diphtheria, tetanus, whole cell pertussis/ Haemophilus influenzae type b vaccine + pneumococcal conjugate vaccine + oral polio vaccine.
Who cannot join
- Child in care
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal abnormality, as determined by physical examination and/or laboratory screening tests.
- Laboratory screening tests out of range, which in the investigator's opinion affects the ability of the child to take part in the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects.
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- History of any neurological disorders or seizures.
- Any condition or illness or medication, which in the opinion of the investigator might interfere with the evaluation of the safety or immunogenicity of the study vaccine.
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
- Acute disease and/or fever at the time of enrolment.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- For the 'Within Expanded Programme on Immunisation' Cohort only: Previous vaccination with diphtheria, tetanus, pertussis, Haemophilus influenzae type b and pneumococcal conjugate vaccine.
- History of previous administration of experimental Mycobacterium tuberculosis vaccines.
- Administration of immunoglobulins, blood transfusions and/or other blood products since birth to the first dose of study vaccine or planned administration during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned participation or concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements
- History of allergic reactions or anaphylaxis to any vaccine.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
- Severe malnutrition at screening defined as weight-for-age Z-score < -3 standard deviation.
- Children will not be enrolled if any maternal, obstetrical or neonatal event that has occurred might, in the judgment of the investigator, result in increased neonatal/infant morbidity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy Infants
This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals' candidate tuberculosis vaccine (692342) when administered concomitantly with or after the Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and including 2 and 7 months, living in a tuberculosis endemic region.
- Conditions
- Tuberculosis
- Being tested
- GSK's investigational vaccine 692342, Tritanrix™ HB+Hib, Prevnar™, Polio Sabin™, Menjugate™
- Keywords
- Tuberculosis vaccine
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK's investigational vaccine 692342Biological
Intramuscular, 1 or 2 doses
Tritanrix™ HB+HibBiological
Intramuscular, 3 doses
Prevnar™Biological
Intramuscular, 3 doses
Polio Sabin™Biological
Oral, 3 doses
Menjugate™Biological
Intramuscular, 3 doses
| Study group | Role | What they receive |
|---|---|---|
| SB692342 2 dose Group | Experimental | 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. Receives: Biological: GSK's investigational vaccine 692342 |
| SB692342 1 dose Group | Experimental | 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. Receives: Biological: GSK's investigational vaccine 692342 |
| Control Menjugate Group | Active comparator | 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. Receives: Biological: Menjugate™ |
| SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group | Experimental | 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. Receives: Biological: GSK's investigational vaccine 692342; Biological: Tritanrix™ HB+Hib; Biological: Prevnar™; Biological: Polio Sabin™ |
| SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group | Experimental | 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. Receives: Biological: GSK's investigational vaccine 692342; Biological: Tritanrix™ HB+Hib; Biological: Prevnar™; Biological: Polio Sabin™ |
| Control Tritanrix + Prevnar + Polio Sabin Group | Active comparator | 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. Receives: Biological: Tritanrix™ HB+Hib; Biological: Prevnar™; Biological: Polio Sabin™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 0 to Day 6
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.
Measured: From Day 0 to Day 6
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.
Measured: From Day 0 to Day 6
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.
Measured: From Day 0 to Day 6
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.
Measured: From Day 0 to Day 29
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.
Measured: From Month 0 to Month 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 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.
Measured: At Day 0
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.
Measured: At Day 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 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.
Measured: At Day 37
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.
Measured: At Day 67
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.
Measured: At Month 1
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.
Measured: At Month 2
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.
Measured: At Month 3
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.
Measured: At Month 6
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.
Measured: At Month 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 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.
Measured: Six Months post Dose 3 [At Month 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.
Measured: At Month 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.
Measured: Twelve Months post Dose 2 [At Month 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.
Measured: At Month 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.
Measured: At Month 8
Secondary outcomes (41)
Frequency of 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).
Measured: Before vaccination (PRE)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
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).
Measured: Seven Days post each dose (D7)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
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).
Measured: One Month post each dose (M1)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
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).
Measured: Six Months post each dose (M6)
Frequency of 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).
Measured: Twelve Months post each dose (M12)
Frequency of 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).
Measured: Before vaccination (PRE)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
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).
Measured: Seven Days after each dose (D7)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
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).
Measured: One Month after each dose (M1)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
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).
Measured: Six Months after each dose (M6)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
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).
Measured: Twelve Months after each dose (M12)
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).
Measured: Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)]
Concentration of Antibodies Against M72 Antigen
Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs).
Measured: Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)]
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).
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Anti-D, Anti-T Antibody Concentrations
Concentrations given in IU/mL, were expressed as Geometric Mean Concentrations (GMCs).
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
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).
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Anti-PRP Antibody Concentrations
Concentrations given in µg/mL were expressed as Geometric Mean Concentrations (GMCs).
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
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.
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Anti-BPT Antibody Concentrations
Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs).
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
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).
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL
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.
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Anti-HB Antibody Concentrations
Concentrations given in mIU/mL were expressed as Geometric Mean Concentrations (GMCs).
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
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.
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers
Concentrations given in titers were expressed as Geometric Mean Titers (GMTs).
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F)
A seropositive subject was a subject whose anti-S pneumoniae antibody concentration was ≥ 0.05 µg/mL.
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
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.
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations
Concentrations, given in µg/mL, were expressed as Geometric Mean Concentrations (GMCs).
Measured: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
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.
Measured: From Day 0 up to 12 months post last vaccination
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.
Measured: Before vaccination (PRE)
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.
Measured: Seven days post Dose 1 [PI(D7)]
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.
Measured: Seven days post Dose 2 [PII(D37)]
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.
Measured: Seven days post Dose 3 [PIII(D67)]
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.
Measured: One Month post Dose 1 [PI(M1)]
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.
Measured: One Month post Dose 2 [PII(M2)]
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.
Measured: One Month post Dose 3 [PIII(M3)]
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.
Measured: Six Months post Dose 1 [PI(M6)]
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.
Measured: Six Months post Dose 2 [PII(M7)]
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.
Measured: Six Months post Dose 3 [PIII(M8)]
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.
Measured: Six Months post Dose 3 [PIII(M13)]
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.
Measured: Twelve Months post Dose 1 [PI(M12)]
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.
Measured: Twelve Months post Dose 2 [PII(M13)]
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.
Measured: Twelve Months post Dose 3 [PIII(M14)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study start7 Jul 2010
- Primary completion30 Apr 2011
- Study completion16 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aeras
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098474
- Sponsor's protocol ID
- 112899
- Other IDs
- 2012-004380-44
- Status last verified
- Jun 2019
- First submitted
- 18 Mar 2010
- Last updated
- 27 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy Infants
- ClinicalTrials.gov ID
- NCT01098474
- Acronym / sponsor ID
- 112899
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Aeras
- Study start
- 7 Jul 2010 (actual)
- Primary completion
- 30 Apr 2011 (actual)
- Study completion
- 16 Mar 2012 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Posted 27 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SB692342 2 dose Group | Experimental | Biological: GSK's investigational vaccine 692342Subjects 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. |
| SB692342 1 dose Group | Experimental | Biological: GSK's investigational vaccine 692342Subjects 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. |
| Control Menjugate Group | Active comparator | Biological: Menjugate™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. |
| SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group | Experimental | Biological: GSK's investigational vaccine 692342, Biological: Tritanrix™ HB+Hib, Biological: Prevnar™, Biological: Polio Sabin™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. |
| SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group | Experimental | Biological: GSK's investigational vaccine 692342, Biological: Tritanrix™ HB+Hib, Biological: Prevnar™, Biological: Polio Sabin™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. |
| Control Tritanrix + Prevnar + Polio Sabin Group | Active comparator | Biological: Tritanrix™ HB+Hib, Biological: Prevnar™, Biological: Polio Sabin™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. |
Who may qualify
- Ages
- 2 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Male and female subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative (LAR(s)) can and will comply with the requirements of the protocol.
- Written or oral, signed or thumb-printed and witnessed informed consent obtained from the subject's parent(s)/LAR(s).
- Subjects who received their birth dose of Bacille Calmette Guerrin.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Must have documented evidence that he/she has completed the primary Expanded Programme on Immunisation regimen at least 1 month prior to planned vaccination with investigational vaccination regimen.
Key exclusion criteria (21 listed)
- Child in care
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal abnormality, as determined by physical examination and/or laboratory screening tests.
- Laboratory screening tests out of range, which in the investigator's opinion affects the ability of the child to take part in the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK's investigational vaccine 692342Intramuscular, 1 or 2 doses | Biological | SB692342 1 dose Group, SB692342 2 dose Group, SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group, SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group |
| Tritanrix™ HB+HibIntramuscular, 3 doses | Biological | Control Tritanrix + Prevnar + Polio Sabin Group, SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group, SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group |
| Prevnar™Intramuscular, 3 doses | Biological | Control Tritanrix + Prevnar + Polio Sabin Group, SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group, SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group |
| Polio Sabin™Oral, 3 doses | Biological | Control Tritanrix + Prevnar + Polio Sabin Group, SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group, SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group |
| Menjugate™Intramuscular, 3 doses | Biological | Control Menjugate Group |
Primary outcome
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses
Time frame: From Day 0 to Day 6
Solicited local symptoms assessed were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses.
Time frame: From Day 0 to Day 6
Solicited local symptoms were only collected after Dose 2 of EPI vaccination. Solicited local symptoms assessed were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses.
Time frame: From Day 0 to Day 6
Solicited general symptoms assessed were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability/fussiness and loss of appetite. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C.
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses.
Time frame: From Day 0 to Day 6
Solicited general symptoms were only collected after Dose 2 of EPI vaccination. Solicited general symptoms assessed were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability/fussiness and loss of appetite. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C.
Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs)
Time frame: From Day 0 to Day 29
An unsolicited adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Month 0 to Month 17
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: At Day 0
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 grams per deciliter (g/dL); WBC.: 1.0 to 1.4 x 10³/micro liter (µL); PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x upper limit of normal (ULN) and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: At Day 7
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: At Day 37
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: At Day 67
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: At Month 1
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: At Month 2
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: At Month 3
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: At Month 6
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: At Month 7
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: Six Months post Dose 3 [At Month 13]
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: At Month 12
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: Twelve Months post Dose 2 [At Month 13]
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: At Month 14
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
Number of Subjects With Grade 3 Haematological and Biochemical Levels
Time frame: At Month 8
Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.
41 secondary outcomes
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Time frame: Before vaccination (PRE)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Time frame: Seven Days post each dose (D7)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Time frame: One Month post each dose (M1)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Time frame: Six Months post each dose (M6)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Time frame: Twelve Months post each dose (M12)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Time frame: Before vaccination (PRE)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Time frame: Seven Days after each dose (D7)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Time frame: One Month after each dose (M1)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Time frame: Six Months after each dose (M6)
Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers
Time frame: Twelve Months after each dose (M12)
Number of Seropositive Subjects Against M72 Antigen
Time frame: Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)]
Concentration of Antibodies Against M72 Antigen
Time frame: Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)]
Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T)
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Anti-D, Anti-T Antibody Concentrations
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP)
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Anti-PRP Antibody Concentrations
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT)
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Anti-BPT Antibody Concentrations
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Number of Seropositive Subjects Against Hepatitis B (Anti-HB)
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Anti-HB Antibody Concentrations
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3)
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F)
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations
Time frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Day 0 up to 12 months post last vaccination
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers
Time frame: Before vaccination (PRE)
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Time frame: Seven days post Dose 1 [PI(D7)]
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Time frame: Seven days post Dose 2 [PII(D37)]
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Time frame: Seven days post Dose 3 [PIII(D67)]
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Time frame: One Month post Dose 1 [PI(M1)]
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Time frame: One Month post Dose 2 [PII(M2)]
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Time frame: One Month post Dose 3 [PIII(M3)]
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Time frame: Six Months post Dose 1 [PI(M6)]
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Time frame: Six Months post Dose 2 [PII(M7)]
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Time frame: Six Months post Dose 3 [PIII(M8)]
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Time frame: Six Months post Dose 3 [PIII(M13)]
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Time frame: Twelve Months post Dose 1 [PI(M12)]
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers
Time frame: Twelve Months post Dose 2 [PII(M13)]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25305000Idoko 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.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK's investigational vaccine 692342, Tritanrix™ HB+Hib and Prevnar™ in people with Tuberculosis, run by GlaxoSmithKline at 1 site in The Gambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses (time frame: From Day 0 to Day 6). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01098474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.