Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants

This study has been completed.
Sponsor:
Collaborators:
PATH
Department of State for Health and Social Welfare, The Gambia
Medical Research Council Unit, The Gambia
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01262872
First received: December 2, 2010
Last updated: April 24, 2014
Last verified: March 2014

December 2, 2010
April 24, 2014
February 2011
March 2013   (final data collection date for primary outcome measure)
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination - For Step 1/Cohort 1 Subjects [ Time Frame: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]
    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). All solicited local symptoms were systematically considered by the investigators as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 symptoms. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects [ Time Frame: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]
    Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Primary results correspond to results for occurrences of Grade 3 symptoms assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects [ Time Frame: Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]
    An unsolicited AE 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of AE, regardless of intensity or relationship to vaccination. Grade 3 = Occurrence of AE which prevented normal activities. Related = Occurrence of AE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 unsolicited AE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects [ Time Frame: From Day 0 to Month 1 ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = Occurrence of an SAE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of SAE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Number of Subjects With Non-vaccine Types of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™), but different from vaccine pneumococcal and cross-reactive serotypes, will be considered for this analysis of carriage. Serotypes will be identified through cultures and analysis of the serotypes identified in the nasopharynx.
  • Number of Subjects With Non-vaccine Types of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from vaccine pneumococcal and cross-reactive serotypes, will be considered for this analysis of carriage. Serotypes will be identified through cultures and analysis of the serotypes identified in the nasopharynx.
  • Occurrence of each grade 3 solicited local and general adverse event with relationship to vaccination (Cohort 1) [ Time Frame: Within 4 days (Day 0-Day 3) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (SAEs) with relationship to vaccination (Cohort 1) [ Time Frame: From Day 0 to Day 30 ] [ Designated as safety issue: No ]
  • Occurrence of non-vaccine serotypes of S. pneumoniae in the nasopharynx (Cohort 2) - 3 months after dose 3 [ Time Frame: Three (month 10) months after dose 3 for Groups 7, 8 ] [ Designated as safety issue: No ]
  • Occurrence of non-vaccine serotypes of S. pneumoniae in the nasopharynx (Cohort 2) - 5 months after dose 2 [ Time Frame: Five (month 7) months after dose 2 for Groups 7, 8 ] [ Designated as safety issue: No ]
  • Occurrence of grade 3 unsolicited adverse events with relationship to vaccination (Cohort 1) [ Time Frame: Within 31 days (Day 0-Day 30) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of non-vaccine serotypes of S. pneumoniae in the nasopharynx (Cohort 2) - 1 month after dose 3 [ Time Frame: One (Month 3) month after dose 3 for Groups 3, 4, 5, 6 ] [ Designated as safety issue: No ]
  • Occurrence of non-vaccine serotypes of S. pneumoniae in the nasopharynx (Cohort 2) - 5 months after dose 3 [ Time Frame: Five (month 7) months after dose 3 for Groups 3, 4, 5 and 6 ] [ Designated as safety issue: No ]
  • Occurrence of non-vaccine serotypes of S. pneumoniae in the nasopharynx (Cohort 2) - 8 months after dose 3 [ Time Frame: Eight (month 10) months after dose 3 for Groups 3, 4, 5 and 6 ] [ Designated as safety issue: No ]
  • Occurrence of non-vaccine serotypes of S. pneumoniae in the nasopharynx (Cohort 2) - 1 month after dose 2 [ Time Frame: One (month 3) month after dose 2 for Groups 7, 8 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01262872 on ClinicalTrials.gov Archive Site
  • Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]
    Assessed biochemical and haematological parameters were: Haemoglobin (Hgb), White cell count (WBC), Platelet counts, Alanine aminotransferase (ALT) and Creatinine (CREA). Per parameter, it was assessed whether subjects had laboratory values below normal, normal, or above normal range. Below = value below the laboratory reference range defined for the specified time point and laboratory parameter. Within = value within the laboratory reference range defined for the specified time point and laboratory parameter. Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. Unknown = value unknown for the specified time point and laboratory parameter. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Number of Subjects With Serious Adverse Events (SAEs) - For Step 1/Cohort 1 Subjects [ Time Frame: From Day 0 to Month 6 ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]

    Anti-Ply and anti-PhtD antibody concentrations were measured by Multiplex immunoassay and expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL).

    Cut-off of the assay were concentrations higher than or equal to (≥) 599 LU/mL for anti-Ply antibodies and ≥ 391 LU/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 1/Step 1.

  • Antibody Concentrations Against Protein D (PD) - For Cohort 1/Step 1 Subjects [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]
    Anti-PD antibody concentrations were measured by Multiplex immunoassay, expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 112 LU/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]
    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]
    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Antibody Concentrations Against Vaccine Serotypes 6C - For Cohort 1/Step 1 Subjects [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]
    No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]
    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]
    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Titers for Opsonophagocytic Activity Against Vaccine Serotypes 6C - For Cohort 1/Step 1 Subjects [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]
    No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-dPly Antibodies - For Cohort 1/Step 1 Subjects [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ] [ Designated as safety issue: No ]
    Concentrations of Hem-dPly antibodies were expressed as geometric mean titers . The cut-off of the assay was an Hem-dPly antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 1/Step 1.
  • Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]

    Anti-Ply and anti-PhtD antibody concentrations were measured by Multiplex immunoassay and expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL).

    Cut-off of the assay were concentrations higher than or equal to (≥) 599 LU/mL for anti-Ply antibodies and ≥ 391 LU/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule. Results will be posted when they become available.

  • Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]

    Anti-Ply and anti-PhtD antibody concentrations were measured by Multiplex immunoassay and expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL).

    Cut-off of the assay were concentrations higher than or equal to (≥) 599 LU/mL for anti-Ply antibodies and ≥ 391 LU/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule. Results will be posted when they become available.

  • Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    Anti-PD antibody concentrations were measured by Multiplex immunoassay, expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 112 LU/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule. Results will be posted when they become available.
  • Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    Anti-PD antibody concentrations were measured by Multiplex immunoassay, expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 112 LU/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule. Results will be posted when they become available.
  • Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule. Results will be posted when they become available.
  • Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule. Results will be posted when they become available.
  • Antibody Concentrations Against Vaccine Serotypes 3, 6A, 6C and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule. Results will be posted when they become available.
  • Antibody Concentrations Against Vaccine Serotypes 3, 6A, 6C and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule. Results will be posted when they become available.
  • Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A, 6C and 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A, 6C and 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-dPly Antibodies - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    Concentrations of Hem-dPly antibodies were expressed as geometric mean titers, in titers. The cut-off of the assay was an Hem-dPly antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-dPly Antibodies - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    Concentrations of Hem-dPly antibodies were expressed as geometric mean titers, in titers. The cut-off of the assay was an Hem-dPly antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Concentrations of Antibodies Against Tetanus (Anti-T), Diphtheria (Anti-T), Bordetella Pertussis (Anti-BPT) and Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix or Prevnar 13™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Concentrations of Antibodies Against Tetanus (Anti-T), Diphtheria (Anti-T), Bordetella Pertussis (Anti-BPT) and Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix or Prevnar 13™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix or Prevnar 13™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Titers of Antibodies Against Measles (Anti-Measles) and Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 3 months post-vaccination with Stamaril™/M-Vac™ ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Titers of Antibodies Against Measles (Anti-Measles) and Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 3 months post-vaccination with Stamaril™/M-Vac™ ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. [ Time Frame: Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses ] [ Designated as safety issue: No ]
    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 3+0 Schedule.
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. [ Time Frame: Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses ] [ Designated as safety issue: No ]
    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. [ Time Frame: Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.
  • Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule [ Time Frame: Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses ] [ Designated as safety issue: No ]
    Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.
  • Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule [ Time Frame: Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses ] [ Designated as safety issue: No ]
    Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
  • Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule [ Time Frame: Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
  • Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule [ Time Frame: Within the 31-day (Days 0-30) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses ] [ Designated as safety issue: No ]
    An unsolicited AE 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.
  • Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule [ Time Frame: Within the 31-day (Days 0-30) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses ] [ Designated as safety issue: No ]
    An unsolicited AE 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
  • Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule [ Time Frame: Within the 31-day (Days 0-30) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    An unsolicited AE 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule. Data for this outcome are unavailable as Step 2 of the study is still ongoing and data for this step remain blinded. Results will be posted when they become available.
  • Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule [ Time Frame: From Day 0 to Month 10 ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Data for this outcome are unavailable as Step 2 of the study is still ongoing and data for this step remain blinded. Results will be posted when they become available.
  • Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule [ Time Frame: From Day 0 to Month 10 ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Data for this outcome are unavailable as Step 2 of the study is still ongoing and data for this step remain blinded. Results will be posted when they become available.
  • Number of Subjects With Vaccine Pneumoccocal Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    A S. pn. vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Number of Subjects With Vaccine Pneumoccocal Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    A S. pn. vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Number of Subjects With Vaccine Cross-reactive Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    S. pn. vaccine cross-reactive 6A, 6C and 19A serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Number of Subjects With Vaccine Cross-reactive Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    S. pn. vaccine cross-reactive 6A, 6C and 19A serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Number of Subjects With Acquisition of New Streptococcus Pneumoniae (S. pn.) Strains Identified in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Number of Subjects With Acquisition of New Streptococcus Pneumoniae (S. pn.) Strains Identified in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Number of Subjects With Vaccine Haemophilus Influenzae (H. Influenzae) Strains Identified in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Number of Subjects With Vaccine Haemophilus Influenzae (H. Influenzae) Strains Identified in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Number of Subjects With Vaccine Bacterial Pathogenic Strains Identified in the Nasopharynx Other Than Streptococcus Pneumoniae or Haemophilus Influenzae Strains - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    The bacterial pathogenic strains assessed included Staphylococcus aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Number of Subjects With Vaccine Bacterial Pathogenic Strains Identified in the Nasopharynx Other Than Streptococcus Pneumoniae or Haemophilus Influenzae Strains - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    The bacterial pathogenic strains assessed included Staphylococcus aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Number of Subjects With Non-vaccine Streptococcus Pneumoniae (S. pn.) Strains Identified in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    Non-vaccine S. pn. strains were defined as S. pn. strains other than the vaccine S. pn. pneumococcal and cross-reactive serotypes, e. a. serotypes other than the 1, 3, 4, 5, 6A, 6B, 6C, 7F, 9V, 14, 18C, 19A, 19F and 23F serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Number of Subjects With Non-vaccine Streptococcus Pneumoniae (S. pn.) Strains Identified in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    Non-vaccine S. pn. strains were defined as S. pn. strains other than the vaccine S. pn. pneumococcal and cross-reactive serotypes, e. a. serotypes other than the 1, 3, 4, 5, 6A, 6B, 6C, 7F, 9V, 14, 18C, 19A, 19F and 23F serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Number of Subjects With Non-vaccine Haemophilus Influenzae Strains Identified in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Number of Subjects With Non-vaccine Haemophilus Influenzae Strains Identified in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Number of Subjects With Non-vaccine Bacterial Pathogenic Strains Identified in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ] [ Designated as safety issue: No ]
    The bacterial pathogenic strains assessed were strains other than Streptococcus pneumoniae or Haemophilus influenzae strains and other than the vaccine-related Staphylococcus aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Results will be posted when they become available.
  • Number of Subjects With Non-vaccine Bacterial Pathogenic Strains Identified in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ] [ Designated as safety issue: No ]
    The bacterial pathogenic strains assessed were strains other than Streptococcus pneumoniae or Haemophilus influenzae strains and other than the vaccine-related Staphylococcus aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Results will be posted when they become available.
  • Occurrence of each solicited local and general adverse event (Cohort 1 and 2) [ Time Frame: Within 4 days (Day 0-Day 3) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of any unsolicited adverse event (Cohort 1 and 2) [ Time Frame: Within 31 days (Day 0-Day 30) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of any SAEs (Cohort 1) [ Time Frame: From Day 0 to Day 30 ] [ Designated as safety issue: No ]
  • Occurrence of any SAEs (Cohort 1) [ Time Frame: From Day 0 to 180 ] [ Designated as safety issue: No ]
  • Occurrence of any SAEs (Cohort 2) [ Time Frame: From Day 0 to Day 300 ] [ Designated as safety issue: No ]
  • Occurrence of any specified haematological or biochemical abnormalities (Cohort 2) [ Time Frame: One month after vaccination (Month 1) ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to the components of the investigational vaccine (Cohort 1) [ Time Frame: One month after vaccination (Month 1) ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to the components of the investigational vaccine (Cohort 2) [ Time Frame: One, five and eight months after dose 3 (Months 3, 7 and 10) for Groups 3, 4, 5, 6 and one, five months after dose 2 (Months 3 and 7) and three months after dose 3 (Month 10) for Groups 7, 8. ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the co-administered DTPw-HBV/Hib vaccine and OPV vaccines (Cohort 2) [ Time Frame: One month after dose 3 (Month 3) ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the co-administered measles and yellow fever vaccines (Cohort 2) [ Time Frame: Three months after vaccination (Month 10) ] [ Designated as safety issue: No ]
  • Occurrence of S. pneumoniae, H. influenzae and other bacterial pathogens in the nasopharynx (Cohort 2) [ Time Frame: One, five and eight months after dose 3 (Months 3, 7 and 10) for Groups 3, 4, 5, 6 and one, five months after dose 2 (Months 3 and 7) and three months after dose 3 (Month 10) for Groups 7 and 8. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants
Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety and Immunogenicity When Co-administered With Routine EPI Vaccines in Infants Following Safety Assessment in Children Aged 2-4 Yrs in The Gambia

This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Two formulations containing different doses of pneumococcal antigen and two different schedules will be tested in infants.

There will be two cohorts in the study: Cohort 1 (children aged 2-4 years) and Cohort 2 (infants aged 8-10 weeks), and two steps in the study, Step 1 and Step 2. Step 1 will consist in a safety evaluation of the GSK Biologicals' pneumococcal vaccine 2189242A (GSK 2189242A or 10PP vaccine). Before evaluating the two formulations of the 10PP vaccine in infants (Cohort 2), safety and reactogenicity of the highest dose formulation of this vaccine will be evaluated in children (Cohort 1). Prevnar 13™ will be used as a control. In the second step of the study, Step 2, two investigational formulations of the 10PP vaccine will be tested in infants (Cohort 2) as regards immunogenicity, reactogenicity and safety. Both formulations of the 10PP vaccine will be evaluated according to the Expanded Programme on Immunization (EPI) schedule i.e. a 2, 3, 4 months vaccination schedule, using licensed Synflorix™ and Prevnar 13™ vaccines as comparators. The higher dose (HD) formulation of the 10PP vaccine will be also evaluated according to the 2, 4, 9 months vaccination schedule using licensed Synflorix™ vaccine as comparator. The study in infants will also assess the immune responses to routine vaccines when co-administered with the candidate pneumococcal vaccine, using licensed Synflorix™ and Prevnar 13™ vaccines as comparators.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Infections, Streptococcal
  • Biological: Pneumococcal vaccine GSK 2189242A (LD formulation 1)
    Intramuscular injection
    Other Names:
    • 10PP
    • LD Formulation
  • Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2)
    Intramuscular injection
    Other Names:
    • 10PP
    • HD Formulation
  • Biological: Synflorix™
    Intramuscular injection
  • Biological: Prevnar13™
    Intramuscular injection
  • Biological: Tritanrix™-HepB/Hib
    Intramuscular injection
  • Biological: Polio Sabin™
    Orally
  • Biological: M-Vac™
    Intramuscular injection
  • Biological: Stamaril™
    Intramuscular injection
  • Experimental: 10PP-HD 1d Group
    This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
    Intervention: Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2)
  • Active Comparator: Prevnar13 1d Group
    This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
    Intervention: Biological: Prevnar13™
  • Experimental: 10PP-LD 3+0d Group
    This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
    Interventions:
    • Biological: Pneumococcal vaccine GSK 2189242A (LD formulation 1)
    • Biological: Tritanrix™-HepB/Hib
    • Biological: Polio Sabin™
    • Biological: M-Vac™
    • Biological: Stamaril™
  • Experimental: 10PP-HD 3+0d Group
    This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
    Interventions:
    • Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2)
    • Biological: Tritanrix™-HepB/Hib
    • Biological: Polio Sabin™
    • Biological: M-Vac™
    • Biological: Stamaril™
  • Active Comparator: Synflorix 3+0d Group
    This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
    Interventions:
    • Biological: Synflorix™
    • Biological: Tritanrix™-HepB/Hib
    • Biological: Polio Sabin™
    • Biological: M-Vac™
    • Biological: Stamaril™
  • Active Comparator: Prevnar13 3+0d Group
    This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
    Interventions:
    • Biological: Prevnar13™
    • Biological: Tritanrix™-HepB/Hib
    • Biological: Polio Sabin™
    • Biological: M-Vac™
    • Biological: Stamaril™
  • Experimental: 10PP-HD 2+1d Group
    This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
    Interventions:
    • Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2)
    • Biological: Tritanrix™-HepB/Hib
    • Biological: Polio Sabin™
    • Biological: M-Vac™
    • Biological: Stamaril™
  • Active Comparator: Synflorix 2+1d Group
    This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
    Interventions:
    • Biological: Synflorix™
    • Biological: Tritanrix™-HepB/Hib
    • Biological: Polio Sabin™
    • Biological: M-Vac™
    • Biological: Stamaril™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1320
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
  • Male or female between, and including,

    • 2 to 4 years of age at the time of the first vaccination for subjects in Cohort 1 (children).
    • 8 to 10 weeks (56-76 days) of age at the time of the first vaccination for subjects in Cohort 2 (infants).
  • Signed or thumb-printed informed consent obtained from the parents/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Permanent residence in the study area and no intention of leaving during the study period.

Additional inclusion criteria for subjects in Cohort 1:

• Previously completed three-dose primary course of diphtheria-tetanus-pertussis (DTP) vaccination.

Exclusion Criteria:

Exclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
  • Previous vaccination against S. pneumoniae.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Malnutrition
  • A family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or any chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Contraindications to any co-administered vaccine.
  • Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.

Additional exclusion criteria for subjects in Cohort 1:

• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b with the exception of vaccines where the first dose should be given within the first two weeks of life according to the national recommendations (for example Bacillus Calmette-Guérin [BCG] and hepatitis B vaccination).

Both
56 Days to 4 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Gambia
 
NCT01262872
114174
Not Provided
GlaxoSmithKline
GlaxoSmithKline
  • PATH
  • Department of State for Health and Social Welfare, The Gambia
  • Medical Research Council Unit, The Gambia
  • London School of Hygiene and Tropical Medicine
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP