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

This study has been completed.
Sponsor:
Collaborator:
Aeras
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01098474
First received: March 18, 2010
Last updated: October 12, 2016
Last verified: August 2012
  Purpose
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.

Condition Intervention Phase
Tuberculosis
Biological: GSK's investigational vaccine 692342
Biological: Tritanrix™ HB+Hib
Biological: Prevnar™
Biological: Polio Sabin™
Biological: Menjugate™
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy Infants

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects with grade 3 solicited local symptoms [ Time Frame: During the 7 day (Days 0-6) post vaccination, after each dose and across doses ] [ Designated as safety issue: No ]
    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 [ Time Frame: During the 7 day (Days 0-6) post vaccination, after each dose and across doses ] [ Designated as safety issue: No ]
    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 [ Time Frame: During the 7 day (Days 0-6) post vaccination, after each dose and across doses ] [ Designated as safety issue: No ]
    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 [ Time Frame: During the 7 day (Days 0-6) post vaccination, after each dose and across doses ] [ Designated as safety issue: No ]
    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: During the 30 day (Days 0-29) post vaccination after each dose ] [ Designated as safety issue: No ]
    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 study start (Day 0) up to Month 1 following the last dose of primary vaccination ] [ Designated as safety issue: No ]
    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: Before vaccination (PRE) ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: Seven days post Dose 1 [PI(D7)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: Seven days post Dose 2 [PII(D37)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: Seven days post Dose 3 [PIII(D67)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: One Month post Dose 1 [PI(M1)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: One Month post Dose 2 [PII(M2)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: One Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: Six Months post Dose 1 [PI(M6)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: Six Months post Dose 2 [PII(M7)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: Six Months post Dose 3 [PIII(M13)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: Twelve Months post Dose 1 [PI(M12)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: Twelve Months post Dose 2 [PII(M13)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: Twelve Months post Dose 3 [PIII(M14)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).

  • Number of subjects with grade 3 haematological and biochemical levels [ Time Frame: Six Months post Dose 3 [PIII(M8)] ] [ Designated as safety issue: No ]
    Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).


Secondary Outcome Measures:
  • Frequency of 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) ] [ Designated as safety issue: No ]
    Immune markers expressed were among Interleukin-2 (IL-2),Interferon-gamma (INF-γ),Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L).

  • Frequency of 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) ] [ Designated as safety issue: No ]
    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).

  • Frequency of 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) ] [ Designated as safety issue: No ]
    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).

  • Frequency of 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) ] [ Designated as safety issue: No ]
    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).

  • Frequency of 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) ] [ Designated as safety issue: No ]
    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).

  • Frequency of 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) ] [ Designated as safety issue: No ]
    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).

  • Frequency of 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) ] [ Designated as safety issue: No ]
    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).

  • Frequency of 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) ] [ Designated as safety issue: No ]
    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).

  • Frequency of 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) ] [ Designated as safety issue: No ]
    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).

  • Frequency of 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) ] [ Designated as safety issue: No ]
    Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).

  • Number of seropositive subjects against M72 antigen [ Time Frame: Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)] ] [ Designated as safety issue: No ]
    A seropositive subject was a subject whose M72 antibody concentration was greater than or equal to 2.8 ELISA units per millilitre (EL.U/mL).

  • Concentration of antibodies against M72 antigen [ Time Frame: Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)] ] [ Designated as safety issue: No ]
    Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs).

  • Number of seroprotected subjects against diphtheria toxoid (Anti-D) and tetanus toxoid (Anti-T) [ Time Frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    A seroprotected subject was a subject whose anti-diphtheria toxoid (anti-D)/anti-tetanus toxoid (anti-T) antibody concentration was ≥ 0.1 international-units per millilitre (IU/mL).

  • Anti-D, Anti-T antibody concentrations [ Time Frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    Concentrations given in IU/mL, were expressed as Geometric Mean Concentrations (GMCs).

  • Number of seroprotected subjects against Haemophilus influenzae Type B (Anti-PRP) [ Time Frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    A seroprotected subject was a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per millilitre (µg/mL).

  • Anti-PRP antibody concentrations [ Time Frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    Concentrations given in µg/mL were expressed as Geometric Mean Concentrations (GMCs).

  • Number of seropositive subjects against Bordetella Pertussis (Anti-BPT) [ Time Frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    A seropositive subject was a subject whose anti-BPT antibody concentration was ≥ 15 EL.U/mL.

  • Anti-BPT antibody concentrations [ Time Frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs).

  • Number of seropositive subjects against Hepatitis B (Anti-HB) [ Time Frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    A seropositive subject was a subject whose anti-HB antibody concentration was ≥ 10 milli-international units per millilitre (mIU/mL).

  • Number of seropositive subjects against Hepatitis B (Anti-HB) with antibody concentrations ≥100mIU/mL [ Time Frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Following from this, the table shows data with titers ≥ 100 mIU/mL.

  • Anti-HB antibody concentrations [ Time Frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    Concentrations given in mIU/mL were expressed as Geometric Mean Concentrations (GMCs).

  • 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)] ] [ Designated as safety issue: No ]
    A seropositive subject was a subject whose anti-polio antibody titer was ≥ 1:8.

  • Anti-Polio1, Anti-Polio2, Anti-Polio3 antibody titers [ Time Frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    Concentrations given in titers were expressed as Geometric Mean Titers (GMTs).

  • 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)] ] [ Designated as safety issue: No ]
    A seropositive subject was a subject whose anti-S pneumoniae antibody concentration was ≥ 0.05 µg/mL.

  • Number of subjects with S. pneumoniae antibody concentrations ≥ 0.2 microgram/milliliter [ Time Frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    A seroconverted subject is a vaccinated subject with at least a four fold increased antibody titer post vaccination.

  • Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F antibody concentrations [ Time Frame: Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    Concentrations, given in µg/mL, were expressed as Geometric Mean Concentrations (GMCs).

  • Number of subjects with serious adverse events (SAEs) [ Time Frame: From Day 0 up to 12 months post last vaccination ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: Before vaccination (PRE) ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: Seven days post Dose 1 [PI(D7)] ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: Seven days post Dose 2 [PII(D37)] ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: Seven days post Dose 3 [PIII(D67)] ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: One Month post Dose 1 [PI(M1)] ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: One Month post Dose 2 [PII(M2)] ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: One Month post Dose 3 [PIII(M3)] ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: Six Months post Dose 1 [PI(M6)] ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: Six Months post Dose 2 [PII(M7)] ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: Six Months post Dose 3 [PIII(M8)] ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: Six Months post Dose 3 [PIII(M13)] ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: Twelve Months post Dose 1 [PI(M12)] ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: Twelve Months post Dose 2 [PII(M13)] ] [ Designated as safety issue: No ]
    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.

  • Levels of haematological and biochemical markers [ Time Frame: Twelve Months post Dose 3 [PIII(M14)] ] [ Designated as safety issue: No ]
    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.


Enrollment: 302
Study Start Date: July 2010
Study Completion Date: March 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects will receive 1 dose of GSK's investigational vaccine 692342.
Biological: GSK's investigational vaccine 692342
Intramuscular, 1 or 2 doses
Experimental: Group B
Subjects will receive 2 doses of GSK's investigational vaccine 692342.
Biological: GSK's investigational vaccine 692342
Intramuscular, 1 or 2 doses
Active Comparator: Group C
Subjects will receive 3 doses of a Menjugate™.
Biological: Menjugate™
Intramuscular, 3 doses
Experimental: Group D
Subjects will receive 1 dose of GSK's investigational vaccine 692342 concomitantly with the last dose of their primary Expanded Programme on Immunisation vaccines regimen.
Biological: GSK's investigational vaccine 692342
Intramuscular, 1 or 2 doses
Biological: Tritanrix™ HB+Hib
Intramuscular, 3 doses
Biological: Prevnar™
Intramuscular, 3 doses
Biological: Polio Sabin™
Oral, 3 doses
Experimental: Group E
Subjects will receive 2 doses of GSK's investigational vaccine 692342, one month apart, concomitantly with the last two doses of their primary Expanded Programme on Immunisation vaccines regimen.
Biological: GSK's investigational vaccine 692342
Intramuscular, 1 or 2 doses
Biological: Tritanrix™ HB+Hib
Intramuscular, 3 doses
Biological: Prevnar™
Intramuscular, 3 doses
Biological: Polio Sabin™
Oral, 3 doses
Active Comparator: Group F
Subjects will receive the primary Expanded Programme on Immunisation vaccines regimen.
Biological: Tritanrix™ HB+Hib
Intramuscular, 3 doses
Biological: Prevnar™
Intramuscular, 3 doses
Biological: Polio Sabin™
Oral, 3 doses

  Eligibility

Ages Eligible for Study:   2 Months to 7 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative (LAR(s)) can and will comply with the requirements of the protocol.
  • Written or oral, signed or thumb-printed and witnessed informed consent obtained from the subject's parent(s)/LAR(s).
  • Subjects who received their birth dose of Bacille Calmette Guerrin.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

For the 'Outside Expanded Programme on Immunisation' cohort:

  • Must have documented evidence that he/she has completed the primary Expanded Programme on Immunisation regimen at least 1 month prior to planned vaccination with investigational vaccination regimen.
  • Aged between 5 and 7 months at the time of the first study vaccination.

For the 'Within EPI' cohort:

  • Must have received the birth dose of Bacille Calmette Guerrin, oral polio vaccine and Hepatitis B vaccine but NO further Expanded Programme on Immunisation vaccines.
  • Aged between 2 and 4 months at the time of the first study vaccination with diphtheria, tetanus, whole cell pertussis/ Haemophilus influenzae type b vaccine + pneumococcal conjugate vaccine + oral polio vaccine.

Exclusion Criteria:

  • Child in care
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal abnormality, as determined by physical examination and/or laboratory screening tests.
  • Laboratory screening tests out of range, which in the investigator's opinion affects the ability of the child to take part in the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects.
  • History of any neurological disorders or seizures.
  • Any condition or illness or medication, which in the opinion of the investigator might interfere with the evaluation of the safety or immunogenicity of the study vaccine.
  • Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
  • Acute disease and/or fever at the time of enrolment.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • For the 'Within Expanded Programme on Immunisation' Cohort only: Previous vaccination with diphtheria, tetanus, pertussis, Haemophilus influenzae type b and pneumococcal conjugate vaccine.
  • History of previous administration of experimental Mycobacterium tuberculosis vaccines.
  • Administration of immunoglobulins, blood transfusions and/or other blood products since birth to the first dose of study vaccine or planned administration during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned participation or concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements
  • History of allergic reactions or anaphylaxis to any vaccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
  • Severe malnutrition at screening defined as weight-for-age Z-score < -3 standard deviation.
  • Children will not be enrolled if any maternal, obstetrical or neonatal event that has occurred might, in the judgment of the investigator, result in increased neonatal/infant morbidity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098474

Locations
Gambia
GSK Investigational Site
Banjul, Gambia
Sponsors and Collaborators
GlaxoSmithKline
Aeras
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01098474     History of Changes
Other Study ID Numbers: 112899 
Study First Received: March 18, 2010
Last Updated: October 12, 2016
Health Authority: Gambia: Gambia Government/MRC Joint Ethics Committee

Keywords provided by GlaxoSmithKline:
Tuberculosis vaccine

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016