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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004380-44 | EudraCT Number |
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| Name | Class |
|---|---|
| Aeras | OTHER |
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This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals' candidate tuberculosis vaccine (692342) when administered concomitantly with or after the Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and including 2 and 7 months, living in a tuberculosis endemic region.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Control Menjugate Group | Active Comparator | Subjects received three doses of the control Menjugateâ„¢ 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 | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK's investigational vaccine 692342 | Biological | Intramuscular, 1 or 2 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Before vaccination (PRE) |
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Inclusion Criteria:
For the 'Outside Expanded Programme on Immunisation' cohort:
For the 'Within EPI' cohort:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Banjul | The Gambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25305000 | Background | 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. |
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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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One enrolled subject was not administered any vaccine and hence was not considered as having started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Control Menjugate Group | Subjects received three doses of the control Menjugateâ„¢ 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Active Phase |
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| Follow Up Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | SB692342 1 Dose Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately. | Posted | Count of Participants | Participants | From Day 0 to Day 6 |
|
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.
Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
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|
| 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. |
|
| 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. |
|
| Tritanrixâ„¢ HB+Hib | Biological | Intramuscular, 3 doses |
|
| Prevnarâ„¢ | Biological | Intramuscular, 3 doses |
|
| Polio Sabinâ„¢ | Biological | Oral, 3 doses |
|
| Menjugateâ„¢ | Biological | Intramuscular, 3 doses |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At Month 8 |
| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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). | 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). | 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. | 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). | 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. | 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). | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Twelve Months post Dose 3 [PIII(M14)] |
| Withdrawal by Subject |
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| Lost to Follow-up |
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| COMPLETED |
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| NOT COMPLETED |
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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. |
| BG002 | Control Menjugate Group | Subjects received three doses of the control Menjugateâ„¢ 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | 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. |
| OG002 | Control Menjugate Group | Subjects received three doses of the control Menjugateâ„¢ 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. |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately. | Posted | Count of Participants | Participants | From Day 0 to Day 6 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately. | Posted | Count of Participants | Participants | From Day 0 to Day 6 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately. | Posted | Count of Participants | Participants | From Day 0 to Day 6 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | From Day 0 to Day 29 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | From Month 0 to Month 17 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | At Day 0 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | At Day 7 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | At Day 37 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | At Day 67 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | At Month 1 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | At Month 2 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | At Month 3 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | At Month 6 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | At Month 7 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | Six Months post Dose 3 [At Month 13] |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | At Month 12 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | Twelve Months post Dose 2 [At Month 13] |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | At Month 14 |
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| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | At Month 8 |
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| Secondary | 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). | The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | T cells/million cells | Before vaccination (PRE) |
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| Secondary | 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). | The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | T cells/million cells | Seven Days post each dose (D7) |
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| Secondary | 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). | The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | T cells/million cells | One Month post each dose (M1) |
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| Secondary | 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). | The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | T cells/million cells | Six Months post each dose (M6) |
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| Secondary | 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). | The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | T cells/million cells | Twelve Months post each dose (M12) |
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| Secondary | 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). | The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | T cells/million cells | Before vaccination (PRE) |
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| Secondary | 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). | The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | T cells/million cells | Seven Days after each dose (D7) |
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| Secondary | 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). | The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | T cells/million cells | One Month after each dose (M1) |
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| Secondary | 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). | The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | T cells/million cells | Six Months after each dose (M6) |
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| Secondary | 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). | The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | T cells/million cells | Twelve Months after each dose (M12) |
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| Secondary | 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). | The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)] |
|
|
|
| Secondary | Concentration of Antibodies Against M72 Antigen | Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs). | The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)] |
|
|
|
| Secondary | 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). | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | Anti-D, Anti-T Antibody Concentrations | Concentrations given in IU/mL, were expressed as Geometric Mean Concentrations (GMCs). | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | 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). | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | Anti-PRP Antibody Concentrations | Concentrations given in µg/mL were expressed as Geometric Mean Concentrations (GMCs). | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | 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. | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | Anti-BPT Antibody Concentrations | Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs). | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | 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). | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | 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. | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | Anti-HB Antibody Concentrations | Concentrations given in mIU/mL were expressed as Geometric Mean Concentrations (GMCs). | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | 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. | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers | Concentrations given in titers were expressed as Geometric Mean Titers (GMTs). | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | 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. | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | 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. | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | 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). | The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | From Day 0 up to 12 months post last vaccination |
|
|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Before vaccination (PRE) |
|
|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Seven days post Dose 1 [PI(D7)] |
|
|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | Seven days post Dose 2 [PII(D37)] |
|
|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | Seven days post Dose 3 [PIII(D67)] |
|
|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | One Month post Dose 1 [PI(M1)] |
|
|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | One Month post Dose 2 [PII(M2)] |
|
|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | One Month post Dose 3 [PIII(M3)] |
|
|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | Six Months post Dose 1 [PI(M6)] |
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|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | Six Months post Dose 2 [PII(M7)] |
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|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | Six Months post Dose 3 [PIII(M8)] |
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|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | Six Months post Dose 3 [PIII(M13)] |
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|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | Twelve Months post Dose 1 [PI(M12)] |
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|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | Twelve Months post Dose 2 [PII(M13)] |
|
|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results. | Posted | Count of Participants | Participants | Twelve Months post Dose 3 [PIII(M14)] |
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|
| 0 |
| 50 |
| 2 |
| 50 |
| 33 |
| 50 |
| EG001 | 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. | 0 | 50 | 3 | 50 | 22 | 50 |
| EG002 | Control Menjugate Group | Subjects received three doses of the control Menjugateâ„¢ 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. | 1 | 50 | 3 | 50 | 31 | 50 |
| EG003 | 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. | 0 | 49 | 1 | 49 | 34 | 49 |
| EG004 | 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. | 0 | 52 | 1 | 52 | 22 | 52 |
| EG005 | 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. | 0 | 49 | 1 | 49 | 26 | 49 |
| Febrile convulsion | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Cerebral malaria | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Malaria | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Drowsiness | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Loss of appetite | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Temperature (Axillary) | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
| Grade 3 Swelling, Dose 2 |
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| Grade 3 Pain, Dose 3 |
|
|
| Grade 3 Swelling, Dose 3 |
|
|
| Grade 3 Pain, Across doses |
|
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| Grade 3 Swelling, Across doses |
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| Grade 3 Irritability, Dose 1 |
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| Grade 3 Loss of appetite, Dose 1 |
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| Grade 3 Temperature /Axillary, Dose 1 |
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| Grade 3 Drowsiness, Dose 2 |
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| Grade 3 Irritability, Dose 2 |
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| Grade 3 Loss of appetite, Dose 2 |
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| Grade 3 Temperature/Axillary, Dose 2 |
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| Grade 3 Drowsiness, Across doses |
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| Grade 3 Irritability, Across doses |
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| Grade 3 Loss of appetite, Across doses |
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| Grade 3 Temperature/Axillary, Across doses |
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| Grade 3 Irritability, Dose 2 |
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| Grade 3 Loss of appetite, Dose 2 |
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| Grade 3 Temperature/Axillary, Dose 2 |
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| Grade 3 Drowsiness, Dose 3 |
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| Grade 3 Irritability, Dose 3 |
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| Grade 3 Loss of appetite, Dose 3 |
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| Grade 3 Temperature/Axillary, Dose 3 |
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| Grade 3 Drowsiness, Across doses |
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| Grade 3 Irritability, Across doses |
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| Grade 3 Loss of appetite, Across doses |
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| Grade 3 Temperature/Axillary, Across doses |
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| WBC, PRE, Grade 3 |
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| PLA, PRE, Grade 3 |
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| ALA, PRE, Grade 3 |
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| CREA, PRE, Grade 3 |
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| Title | Measurements |
|---|---|
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| PLA Grade 3 |
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| ALA Grade 3 |
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| CREA Grade 3 |
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| WBC Grade 3 |
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| PLA Grade 3 |
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| ALA Grade 3 |
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| CREA Grade 3 |
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| Title | Measurements |
|---|---|
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| PLA Grade 3 |
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| ALA Grade 3 |
|
| CREA Grade 3 |
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| Title | Measurements |
|---|---|
|
| PLA Grade 3 |
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| ALA Grade 3 |
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| CREA Grade 3 |
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| PLA Grade 3 |
|
| ALA Grade 3 |
|
| CREA Grade 3 |
|
| Title | Measurements |
|---|---|
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| PLA Grade 3 |
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| ALA Grade 3 |
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| CREA Grade 3 |
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| Title | Measurements |
|---|---|
|
| ALA Grade 3 |
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| CREA Grade 3 |
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| PLA Grade 3 |
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| ALA Grade 3 |
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| CREA Grade 3 |
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| PLA Grade 3 |
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| ALA Grade 3 |
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| CREA Grade 3 |
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| Title | Measurements |
|---|---|
|
| ALA Grade 3 |
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| CREA Grade 3 |
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| PLA Grade 3 |
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| ALA Grade 3 |
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| CREA Grade 3 |
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| Title | Measurements |
|---|---|
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| PLA Grade 3 |
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| ALA Grade 3 |
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| CREA Grade 3 |
|
| Title | Measurements |
|---|---|
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| PLA Grade 3 |
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| ALA Grade 3 |
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| CREA Grade 3 |
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| CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), PRE |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), PRE |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), PRE |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), PRE |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), PRE |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), PRE |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), PRE |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), PRE |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), PRE |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), D7 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), D7 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), D7 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), D7 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), D7 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), D7 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), D7 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), D7 |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), D7 |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), D7 |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), D7 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M1 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M1 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M1 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M1 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M1 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M1 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M1 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M1 |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M1 |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M1 |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M1 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M6 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M6 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M6 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M6 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M6 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M6 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M6 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M6 |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M6 |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M6 |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M6 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 |
|
| CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M12 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M12 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M12 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M12 |
|
| CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M12 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M12 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M12 |
|
| CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M12 |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M12 |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M12 |
|
| CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M12 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),PRE |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),PRE |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),PRE |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),PRE |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),PRE |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),PRE |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),PRE |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),PRE |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),PRE |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),PRE |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),D7 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),D7 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),D7 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),D7 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),D7 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),D7 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),D7 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),D7 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),D7 |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),D7 |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),D7 |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),D7 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M1 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M1 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M1 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M1 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M1 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M1 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M1 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M1 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M1 |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M1 |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M1 |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M1 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M6 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M6 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M6 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M6 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M6 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M6 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M6 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M6 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M6 |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M6 |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M6 |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M6 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 |
|
| CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M12 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M12 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M12 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M12 |
|
| CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M12 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M12 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M12 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M12 |
|
| CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M12 |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M12 |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M12 |
|
| CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M12 |
|
|
| Anti-M72, M1 |
|
|
| Anti-M72, M6 |
|
|
| Anti-M72, M12 |
|
|
|
| Anti-M72, M1 |
|
|
| Anti-M72, M6 |
|
|
| Anti-M72, M12 |
|
|
| Anti-D, PIII(M3) |
|
|
| Anti-T, PRE |
|
|
| Anti-T, PIII(M3) |
|
|
| Anti-D, PIII(M3) |
|
|
| Anti-T, PRE |
|
|
| Anti-T, PIII(M3) |
|
|
| Anti-PRP, PIII(M3) |
|
|
| Anti-PRP, PIII(M3) |
|
|
| Anti-BPT, PIII(M3) |
|
|
| Anti-BPT, PIII(M3) |
|
|
| Anti-HB, PIII(M3) |
|
|
| Anti-HB, PIII(M3) |
|
|
| Anti-HB, PIII(M3) |
|
|
| Anti-Polio1, PIII(M3) |
|
|
| Anti-Polio2, PRE |
|
|
| Anti-Polio2, PIII(M3) |
|
|
| Anti-Polio3, PRE |
|
|
| Anti-Polio3, PIII(M3) |
|
|
| Anti-Polio1, PIII(M3) |
|
|
| Anti-Polio2, PRE |
|
|
| Anti-Polio2, PIII(M3) |
|
|
| Anti-Polio3, PRE |
|
|
| Anti-Polio3, PIII(M3) |
|
|
| Anti-4, PIII(M3) |
|
|
| Anti-6B, PRE |
|
|
| Anti-6B, PIII(M3) |
|
|
| Anti-9V, PRE |
|
|
| Anti-9V,PIII(M3) |
|
|
| Anti-14, PRE |
|
|
| Anti-14, PIII(M3) |
|
|
| Anti-18C, PRE |
|
|
| Anti-18C, PIII(M3) |
|
|
| Anti-19F, PRE |
|
|
| Anti-19F, PIII(M3) |
|
|
| Anti-23F, PRE |
|
|
| Anti-23F, PIII(M3) |
|
|
| Anti-4, PIII(M3) |
|
|
| Anti-6B, PRE |
|
|
| Anti-6B, PIII(M3) |
|
|
| Anti-9V, PRE |
|
|
| Anti-9V, PIII(M3) |
|
|
| Anti-14, PRE |
|
|
| Anti-14, PIII(M3) |
|
|
| Anti-18C, PRE |
|
|
| Anti-18C, PIII(M3) |
|
|
| Anti-19F, PRE |
|
|
| Anti-19F, PIII(M3) |
|
|
| Anti-23F, PRE |
|
|
| Anti-23F, PIII(M3) |
|
|
| Anti-4, PIII(M3) |
|
|
| Anti-6B, PRE |
|
|
| Anti-6B, PIII(M3) |
|
|
| Anti-9V, PRE |
|
|
| Anti-9V, PIII(M3) |
|
|
| Anti-14, PRE |
|
|
| Anti-14, PIII(M3) |
|
|
| Anti-18C, PRE |
|
|
| Anti-18C, PIII(M3) |
|
|
| Anti-19F, PRE |
|
|
| Anti-19F, PIII(M3) |
|
|
| Anti-23F, PRE |
|
|
| Anti-23F, PIII(M3) |
|
|
| Haem, PRE, G1 |
|
| Haem, PRE, G2 |
|
| Haem, PRE, G4 |
|
| Haem, PRE, Missing |
|
| WBC, PRE, Normal |
|
| WBC, PRE, G1 |
|
| WBC, PRE, G2 |
|
| WBC, PRE, G4 |
|
| WBC, PRE, Missing |
|
| PLA, PRE, Normal |
|
| PLA, PRE, G1 |
|
| PLA, PRE, G2 |
|
| PLA, PRE, G4 |
|
| PLA, PRE, Missing |
|
| ALA, PRE, Normal |
|
| ALA, PRE, G1 |
|
| ALA, PRE, G2 |
|
| ALA, PRE, G4 |
|
| ALA, PRE, Missing |
|
| CREA, PRE, Normal |
|
| CREA, PRE, G1 |
|
| CREA, PRE, G2 |
|
| CREA, PRE, G4 |
|
| CREA, PRE, Missing |
|
| Title | Measurements |
|---|---|
|
| Haem, PI(D7), G2 |
|
| Haem, PI(D7), G4 |
|
| Haem, PI(D7), Missing |
|
| WBC, PI(D7), Normal |
|
| WBC, PI(D7), G1 |
|
| WBC, PI(D7), G2 |
|
| WBC, PI(D7), G4 |
|
| WBC, PI(D7), Missing |
|
| PLA, PI(D7), Normal |
|
| PLA, PI(D7), G1 |
|
| PLA, PI(D7), G2 |
|
| PLA, PI(D7), G4 |
|
| PLA, PI(D7), Missing |
|
| ALA, PI(D7), Normal |
|
| ALA, PI(D7), G1 |
|
| ALA, PI(D7), G2 |
|
| ALA, PI(D7), G4 |
|
| ALA, PI(D7), Missing |
|
| CREA, PI(D7), Normal |
|
| CREA, PI(D7), G1 |
|
| CREA, PI(D7), G2 |
|
| CREA, PI(D7), G4 |
|
| CREA, PI(D7), Missing |
|
| Haem, PII(D37), G1 |
|
| Haem, PII(D37), G2 |
|
| Haem, PII(D37), G4 |
|
| Haem, PII(D37), Missing |
|
| WBC, PII(D37), Normal |
|
| WBC, PII(D37), G1 |
|
| WBC, PII(D37), G2 |
|
| WBC, PII(D37), G4 |
|
| WBC, PII(D37), Missing |
|
| PLA, PII(D37), Normal |
|
| PLA, PII(D37), G1 |
|
| PLA, PII(D37), G2 |
|
| PLA, PII(D37), G4 |
|
| PLA, PII(D37), Missing |
|
| ALA, PII(D37), Normal |
|
| ALA, PII(D37), G1 |
|
| ALA, PII(D37), G2 |
|
| ALA, PII(D37), G4 |
|
| ALA, PII(D37), Missing |
|
| CREA, PII(D37), Normal |
|
| CREA, PII(D37), G1 |
|
| CREA, PII(D37), G2 |
|
| CREA, PII(D37), G4 |
|
| CREA, PII(D37), Missing |
|
|
| Haem, PIII(D67), G2 |
|
| Haem, PIII(D67), G4 |
|
| Haem, PIII(D67), Missing |
|
| WBC, PIII(D67), Normal |
|
| WBC, PIII(D67), G1 |
|
| WBC, PIII(D67), G2 |
|
| WBC, PIII(D67), G4 |
|
| WBC, PIII(D67), Missing |
|
| PLA, PIII(D67), Normal |
|
| PLA, PIII(D67), G1 |
|
| PLA, PIII(D67), G2 |
|
| PLA, PIII(D67), G4 |
|
| PLA, PIII(D67), Missing |
|
| ALA, PIII(D67), Normal |
|
| ALA, PIII(D67), G1 |
|
| ALA, PIII(D67), G2 |
|
| ALA, PIII(D67), G4 |
|
| ALA, PIII(D67), Missing |
|
| CREA, PIII(D67), Normal |
|
| CREA, PIII(D67), G1 |
|
| CREA, PIII(D67), G2 |
|
| CREA, PIII(D67), G4 |
|
| CREA, PIII(D67), Missing |
|
| Title | Measurements |
|---|---|
|
| Haem, PI(M1), G2 |
|
| Haem, PI(M1), G4 |
|
| Haem, PI(M1), Missing |
|
| WBC, PI(M1), Normal |
|
| WBC, PI(M1), G1 |
|
| WBC, PI(M1), G2 |
|
| WBC, PI(M1), G4 |
|
| WBC, PI(M1), Missing |
|
| PLA, PI(M1), Normal |
|
| PLA, PI(M1), G1 |
|
| PLA, PI(M1), G2 |
|
| PLA, PI(M1), G4 |
|
| PLA, PI(M1), Missing |
|
| ALA, PI(M1), Normal |
|
| ALA, PI(M1), G1 |
|
| ALA, PI(M1), G2 |
|
| ALA, PI(M1), G4 |
|
| ALA, PI(M1), Missing |
|
| CREA, PI(M1), Normal |
|
| CREA, PI(M1), G1 |
|
| CREA, PI(M1), G2 |
|
| CREA, PI(M1), G4 |
|
| CREA, PI(M1), Missing |
|
| Haem, PII(M2), G2 |
|
| Haem, PII(M2), G4 |
|
| Haem, PII(M2), Missing |
|
| WBC, PII(M2), Normal |
|
| WBC, PII(M2), G1 |
|
| WBC, PII(M2), G2 |
|
| WBC, PII(M2), G4 |
|
| WBC, PII(M2), Missing |
|
| PLA, PII(M2), Normal |
|
| PLA, PII(M2), G1 |
|
| PLA, PII(M2), G2 |
|
| PLA, PII(M2), G4 |
|
| PLA, PII(M2), Missing |
|
| ALA, PII(M2), Normal |
|
| ALA, PII(M2), G1 |
|
| ALA, PII(M2), G2 |
|
| ALA, PII(M2), G4 |
|
| ALA, PII(M2), Missing |
|
| CREA, PII(M2), Normal |
|
| CREA, PII(M2), G1 |
|
| CREA, PII(M2), G2 |
|
| CREA, PII(M2), G4 |
|
| CREA, PII(M2), Missing |
|
|
| Haem, PIII(M3), G2 |
|
| Haem, PIII(M3), G4 |
|
| Haem, PIII(M3), Missing |
|
| WBC, PIII(M3), Normal |
|
| WBC, PIII(M3), G1 |
|
| WBC, PIII(M3), G2 |
|
| WBC, PIII(M3), G4 |
|
| WBC, PIII(M3), Missing |
|
| PLA, PIII(M3), Normal |
|
| PLA, PIII(M3), G1 |
|
| PLA, PIII(M3), G2 |
|
| PLA, PIII(M3), G4 |
|
| PLA, PIII(M3), Missing |
|
| ALA, PIII(M3), Normal |
|
| ALA, PIII(M3), G1 |
|
| ALA, PIII(M3), G2 |
|
| ALA, PIII(M3), G4 |
|
| ALA, PIII(M3), Missing |
|
| CREA, PIII(M3), Normal |
|
| CREA, PIII(M3), G1 |
|
| CREA, PIII(M3), G2 |
|
| CREA, PIII(M3), G4 |
|
| CREA, PIII(M3), Missing |
|
| Title | Measurements |
|---|---|
|
| Haem, PI(M6), G4 |
|
| Haem, PI(M6), Missing |
|
| WBC, PI(M6), Normal |
|
| WBC, PI(M6), G1 |
|
| WBC, PI(M6), G2 |
|
| WBC, PI(M6), G4 |
|
| WBC, PI(M6), Missing |
|
| PLA, PI(M6), Normal |
|
| PLA, PI(M6), G1 |
|
| PLA, PI(M6), G2 |
|
| PLA, PI(M6), G4 |
|
| PLA, PI(M6), Missing |
|
| ALA, PI(M6), Normal |
|
| ALA, PI(M6), G1 |
|
| ALA, PI(M6), G2 |
|
| ALA, PI(M6), G4 |
|
| ALA, PI(M6), Missing |
|
| CREA, PI(M6), Normal |
|
| CREA, PI(M6), G1 |
|
| CREA, PI(M6), G2 |
|
| CREA, PI(M6), G4 |
|
| CREA, PI(M6), Missing |
|
| Haem, PII(M7), G2 |
|
| Haem, PII(M7), G4 |
|
| Haem, PII(M7), Missing |
|
| WBC, PII(M7), Normal |
|
| WBC, PII(M7), G1 |
|
| WBC, PII(M7), G2 |
|
| WBC, PII(M7), G4 |
|
| WBC, PII(M7), Missing |
|
| PLA, PII(M7), Normal |
|
| PLA, PII(M7), G1 |
|
| PLA, PII(M7), G2 |
|
| PLA, PII(M7), G4 |
|
| PLA, PII(M7), Missing |
|
| ALA, PII(M7), Normal |
|
| ALA, PII(M7), G1 |
|
| ALA, PII(M7), G2 |
|
| ALA, PII(M7), G4 |
|
| ALA, PII(M7), Missing |
|
| CREA, PII(M7), Normal |
|
| CREA, PII(M7), G1 |
|
| CREA, PII(M7), G2 |
|
| CREA, PII(M7), G4 |
|
| CREA, PII(M7), Missing |
|
|
| Haem, PIII(M8), G2 |
|
| Haem, PIII(M8), G4 |
|
| Haem, PIII(M8), Missing |
|
| WBC, PIII(M8), Normal |
|
| WBC, PIII(M8), G1 |
|
| WBC, PIII(M8), G2 |
|
| WBC, PIII(M8), G4 |
|
| WBC, PIII(M8), Missing |
|
| PLA, PIII(M8), Normal |
|
| PLA, PIII(M8), G1 |
|
| PLA, PIII(M8), G2 |
|
| PLA, PIII(M8), G4 |
|
| PLA, PIII(M8), Missing |
|
| ALA, PIII(M8), Normal |
|
| ALA, PIII(M8), G1 |
|
| ALA, PIII(M8), G2 |
|
| ALA, PIII(M8), G4 |
|
| ALA, PIII(M8), Missing |
|
| CREA, PIII(M8), Normal |
|
| CREA, PIII(M8), G1 |
|
| CREA, PIII(M8), G2 |
|
| CREA, PIII(M8), G4 |
|
| CREA, PIII(M8), Missing |
|
| Haem, PIII(M13), G2 |
|
| Haem, PIII(M13), G4 |
|
| Haem, PIII(M13), Missing |
|
| WBC, PIII(M13), Normal |
|
| WBC, PIII(M13), G1 |
|
| WBC, PIII(M13), G2 |
|
| WBC, PIII(M13), G4 |
|
| WBC, PIII(M13), Missing |
|
| PLA, PIII(M13), Normal |
|
| PLA, PIII(M13), G1 |
|
| PLA, PIII(M13), G2 |
|
| PLA, PIII(M13), G4 |
|
| PLA, PIII(M13), Missing |
|
| ALA, PIII(M13), Normal |
|
| ALA, PIII(M13), G1 |
|
| ALA, PIII(M13), G2 |
|
| ALA, PIII(M13), G4 |
|
| ALA, PIII(M13), Missing |
|
| CREA, PIII(M13), Normal |
|
| CREA, PIII(M13), G1 |
|
| CREA, PIII(M13), G2 |
|
| CREA, PIII(M13), G4 |
|
| CREA, PIII(M13), Missing |
|
| Title | Measurements |
|---|---|
|
| Haem, PI(M12), G4 |
|
| Haem, PI(M12), Missing |
|
| WBC, PI(M12), Normal |
|
| WBC, PI(M12), G1 |
|
| WBC, PI(M12), G2 |
|
| WBC, PI(M12), G4 |
|
| WBC, PI(M12), Missing |
|
| PLA, PI(M12), Normal |
|
| PLA, PI(M12), G1 |
|
| PLA, PI(M12), G2 |
|
| PLA, PI(M12), G4 |
|
| PLA, PI(M12), Missing |
|
| ALA, PI(M12), Normal |
|
| ALA, PI(M12), G1 |
|
| ALA, PI(M12), G2 |
|
| ALA, PI(M12), G4 |
|
| ALA, PI(M12), Missing |
|
| CREA, PI(M12), Normal |
|
| CREA, PI(M12), G1 |
|
| CREA, PI(M12), G2 |
|
| CREA, PI(M12), G4 |
|
| CREA, PI(M12), Missing |
|
| Haem, PII(M13), G2 |
|
| Haem, PII(M13), G4 |
|
| Haem, PII(M13), Missing |
|
| WBC, PII(M13), Normal |
|
| WBC, PII(M13), G1 |
|
| WBC, PII(M13), G2 |
|
| WBC, PII(M13), G4 |
|
| WBC, PII(M13), Missing |
|
| PLA, PII(M13), Normal |
|
| PLA, PII(M13), G1 |
|
| PLA, PII(M13), G2 |
|
| PLA, PII(M13), G4 |
|
| PLA, PII(M13), Missing |
|
| ALA, PII(M13), Normal |
|
| ALA, PII(M13), G1 |
|
| ALA, PII(M13), G2 |
|
| ALA, PII(M13), G4 |
|
| ALA, PII(M13), Missing |
|
| CREA, PII(M13), Normal |
|
| CREA, PII(M13), G1 |
|
| CREA, PII(M13), G2 |
|
| CREA, PII(M13), G4 |
|
| CREA, PII(M13), Missing |
|
|
| Haem, PIII(M14), G2 |
|
| Haem, PIII(M14), G4 |
|
| Haem, PIII(M14), Missing |
|
| WBC, PIII(M14), Normal |
|
| WBC, PIII(M14), G1 |
|
| WBC, PIII(M14), G2 |
|
| WBC, PIII(M14), G4 |
|
| WBC, PIII(M14), Missing |
|
| PLA, PIII(M14), Normal |
|
| PLA, PIII(M14), G1 |
|
| PLA, PIII(M14), G2 |
|
| PLA, PIII(M14), G4 |
|
| PLA, PIII(M14), Missing |
|
| ALA, PIII(M14), Normal |
|
| ALA, PIII(M14), G1 |
|
| ALA, PIII(M14), G2 |
|
| ALA, PIII(M14), G4 |
|
| ALA, PIII(M14), Missing |
|
| CREA, PIII(M14), Normal |
|
| CREA, PIII(M14), G1 |
|
| CREA, PIII(M14), G2 |
|
| CREA, PIII(M14), G4 |
|
| CREA, PIII(M14), Missing |
|