Infections, Streptococcal
Conditions
Keywords
Haemophilus influenzae, Streptococcus pneumoniae, The Gambia, immunogenicity, nasopharyngeal carriage, infants, safety, Pneumococcal vaccine, children
Brief summary
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.
Detailed description
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.
Interventions
Intramuscular injection
Intramuscular injection
BIOLOGICALSynflorix™
Intramuscular injection
BIOLOGICALPrevnar13™
Intramuscular injection
BIOLOGICALTritanrix™-HepB/Hib
Intramuscular injection
BIOLOGICALPolio Sabin™
Orally
BIOLOGICALM-Vac™
Intramuscular injection
BIOLOGICALStamaril™
Intramuscular injection
Sponsors
PATH
Department of State for Health and Social Welfare, The Gambia
Medical Research Council Unit, The Gambia
London School of Hygiene and Tropical Medicine
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
56 Days to 4 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | 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 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | 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 Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of isolates. |
| Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™) | Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of the isolates. |
| Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects | From Day 0 to Month 1 | 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 Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects | Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | 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 Serotype 6C - For Cohort 1/Step 1 Subjects | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | 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 | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | 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 | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | 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 Serotype 6C - For Cohort 1/Step 1 Subjects | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | 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-Ply Antibodies - For Cohort 1/Step 1 Subjects | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | Concentrations of Hem-Ply antibodies were expressed as geometric mean titers . The cut-off of the assay was an Hem-Ply 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 | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule. |
| 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 | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule. |
| Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule. |
| Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule. |
| 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 | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | 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. |
| 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 | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | 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. |
| Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | 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. |
| Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | 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. |
| Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | 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. |
| Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | 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. |
| Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2. |
| Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2. |
| 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 | At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | 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. |
| 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 | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | 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. |
| Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | 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. |
| Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | 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. |
| Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. |
| Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. |
| Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2. |
| Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | No analysis was performed on opsonophagocytic activity for Antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2. |
| Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. |
| Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. |
| Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL. |
| Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL. |
| Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL. |
| Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL. |
| Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL. |
| Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL. |
| Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL. |
| Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL. |
| 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 | At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8. |
| 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 | At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8. |
| Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™ | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL. |
| Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™ | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL. |
| Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™ | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10. |
| Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™ | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses | 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. | Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses | 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 | Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses | 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 | Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses | 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 | Within the 31-day (Days 0-30) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses | 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 | Within the 31-day (Days 0-30) periods post vaccination with the first 2 doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses | 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 Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule | From Day 0 to Month 10 | 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. |
| Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule | From Day 0 to Month 10 | 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. |
| Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. |
| Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. |
| Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (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. |
| Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (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. |
| Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. |
| Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. |
| Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. |
| Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. |
| Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. |
| Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. |
| Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed.This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. |
| Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. |
| Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. |
| Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. |
| Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. |
| Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. |
| Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. |
| Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. |
| Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. |
| Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. |
| Number of Subjects With Serious Adverse Events (SAEs) - For Step 1/Cohort 1 Subjects | From Day 0 to Month 6 | 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 Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | 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. |
| Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | 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. |
| Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | 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 | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene - Cohort 2 | At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule) | Isolates from the Prev13\_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence). |
| Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule) | Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage. |
| Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule) | Because of high variants heterogeneity in each group (no major variant), the impact of vaccination on variant prevalence was not analysed. PhtD sequences were detected in some samples but no consensus sequence could be obtained they were defined as mixed sequences (Mix). The samples without gene detected were considered as negative for PhtD (PhtD negative). |
| Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule) | Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage. |
| Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule) | Overall, 18 different Ply protein sequences were identified: 5 protein variants previously described (e.g. variants 1, 2, 7, 11 and 15), plus 13 new protein variants which are referred to as variants GSK21 to GSK33. The number of Amino Acids (AA) mutation versus vaccine sequence has been specified for each Ply variant. The samples without gene detected were considered as negative for Ply (Ply negative). |
| Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene - Cohort 2 | At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule) | Isolates from the Prev13\_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence). |
Countries
The Gambia
Participant flow
Recruitment details
Cohort 1 subjects participated in Step 1 (duration of about 6 months). Cohort 2 subjects participated in Step 2 (duration of about 10 months). Enrolment for Step 2 was conditional upon successful results of a post-vaccination safety evaluation of all children enrolled in Cohort 1 by an Independent Data Monitoring Committee.
Pre-assignment details
Description of any significant events and approaches for the overall study following participant enrollment, but prior to group assignment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 60 |
| 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. | 200 |
| 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. | 200 |
| 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. | 200 |
| 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. | 200 |
| 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. | 200 |
| 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. | 200 |
| Total | 1,320 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Step 2 | Death | 0 | 0 | 0 | 1 | 0 | 2 | 2 | 1 |
| Step 2 | Migrated/moved from study area | 0 | 0 | 4 | 3 | 2 | 6 | 2 | 3 |
| Step 2 | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 1 |
| Step 2 | Withdrawal by Subject | 0 | 0 | 4 | 6 | 3 | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | 10PP-HD 1d Group | Prevnar13 1d Group | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | NA Weeks | NA Weeks | 8.5 Weeks STANDARD_DEVIATION 0.64 | 8.4 Weeks STANDARD_DEVIATION 0.61 | 8.4 Weeks STANDARD_DEVIATION 0.63 | 8.5 Weeks STANDARD_DEVIATION 0.69 | 8.5 Weeks STANDARD_DEVIATION 0.7 | 8.5 Weeks STANDARD_DEVIATION 0.7 | 8.5 Weeks STANDARD_DEVIATION 0.66 |
| Race/Ethnicity, Customized African heritage | NA Participants | NA Participants | 200 Participants | 200 Participants | 200 Participants | 200 Participants | 200 Participants | 200 Participants | NA Participants |
| Sex: Female, Male Female | 41 Participants | 26 Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | 95 Participants | 102 Participants | 97 Participants | 97 Participants | 97 Participants | 103 Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 | 0 / 200 | 1 / 200 | 0 / 200 | 2 / 200 | 2 / 200 | 1 / 200 |
| other Total, other adverse events | 9 / 60 | 3 / 60 | 186 / 200 | 191 / 200 | 193 / 200 | 188 / 200 | 189 / 200 | 184 / 200 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 1 / 200 | 4 / 200 | 3 / 200 | 2 / 200 | 4 / 200 | 5 / 200 |
Outcome results
Primary
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
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.
Time frame: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Any Drowsiness | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Any Irritability/Fussiness | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Any Fever | 4 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 Irritability/Fussiness | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Related Drowsiness | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Related Irritability/Fussiness | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 Fever | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 & Related Irritability/Fussiness | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 Drowsiness | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Any Loss of appetite | 1 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Related Fever | 1 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 Loss of appetite | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 & Related Drowsiness | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 & Related Fever | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 & Related Loss of appetite | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Related Loss of appetite | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 & Related Loss of appetite | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Any Drowsiness | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 Drowsiness | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Related Drowsiness | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 & Related Drowsiness | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Any Fever | 2 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 Fever | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Related Fever | 1 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 & Related Fever | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Any Irritability/Fussiness | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 Irritability/Fussiness | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Related Irritability/Fussiness | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 & Related Irritability/Fussiness | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Any Loss of appetite | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Grade 3 Loss of appetite | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects | Related Loss of appetite | 0 Participants |
Primary
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
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.
Time frame: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | 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 | Any Pain | 0 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Pain | 0 Participants |
| 10PP-HD 1d Group | 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 | Any Redness | 0 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Redness | 0 Participants |
| 10PP-HD 1d Group | 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 | Any Swelling | 1 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Swelling | 1 Participants |
| Prevnar13 1d Group | 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 | Any Swelling | 0 Participants |
| Prevnar13 1d Group | 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 | Any Pain | 0 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Redness | 0 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Pain | 0 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Swelling | 0 Participants |
| Prevnar13 1d Group | 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 | Any Redness | 0 Participants |
Primary
Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects
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.
Time frame: Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects | Any unsolicited AE(s) | 13 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects | Grade 3 unsolicited AE(s) | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects | Related unsolicited AE(s) | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects | Grade 3 and related unsolicited AE(s) | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects | Grade 3 and related unsolicited AE(s) | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects | Any unsolicited AE(s) | 7 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects | Related unsolicited AE(s) | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects | Grade 3 unsolicited AE(s) | 0 Participants |
Primary
Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects
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.
Time frame: From Day 0 to Month 1
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects | Any SAE(s) | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects | SAE(s) related to vaccination | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects | SAE(s) related to vaccination | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects | Any SAE(s) | 0 Participants |
Primary
Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule
Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of isolates.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule | 1 Mth post dose 2 | 142 Participants |
| 10PP-HD 1d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule | 5 Mth post dose 2 | 146 Participants |
| 10PP-HD 1d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule | 3 Mth post dose 3 | 165 Participants |
| Prevnar13 1d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule | 1 Mth post dose 2 | 152 Participants |
| Prevnar13 1d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule | 5 Mth post dose 2 | 160 Participants |
| Prevnar13 1d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule | 3 Mth post dose 3 | 162 Participants |
Comparison: VE-10PP-HD 2+1d vs Synflorix 2+1d - 1M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).95% CI: [-18.2, 26.2]
Comparison: VE-10PP-HD 2+1d vs Synflorix 2+1d - 5M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).95% CI: [-18, 25.7]
Comparison: VE-10PP-HD 2+1d vs Synflorix 2+1d - 3M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, three months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).95% CI: [-29.3, 17.2]
Primary
Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule
Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of the isolates.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule | 5 Mth post dose 3 | 148 Participants |
| 10PP-HD 1d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule | 1 Mth post dose 3 | 154 Participants |
| 10PP-HD 1d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule | 8 Mth post dose 3 | 151 Participants |
| Prevnar13 1d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule | 5 Mth post dose 3 | 149 Participants |
| Prevnar13 1d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule | 1 Mth post dose 3 | 137 Participants |
| Prevnar13 1d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule | 8 Mth post dose 3 | 154 Participants |
| Synflorix 3+0d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule | 1 Mth post dose 3 | 145 Participants |
| Synflorix 3+0d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule | 8 Mth post dose 3 | 159 Participants |
| Synflorix 3+0d Group | Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule | 5 Mth post dose 3 | 159 Participants |
Comparison: VE-10PP-LD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).95% CI: [-36.3, 14.6]
Comparison: VE-10PP-LD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).95% CI: [-17.8, 25.7]
Comparison: VE-10PP-LD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).95% CI: [-22.6, 22.5]
Comparison: VE-10PP-HD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).95% CI: [-21.4, 25]
Comparison: VE-10PP-HD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).95% CI: [-19.2, 24.8]
Comparison: VE-10PP-HD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).95% CI: [-24.9, 20.9]
Secondary
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects
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.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects | Anti-Ply | 22794.9 LU/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects | Anti-PhtD | 31326.3 LU/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects | Anti-Ply | 8510.3 LU/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects | Anti-PhtD | 16810.0 LU/mL |
Secondary
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
Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | 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 | Anti-Ply 1 Mth post dose 2 | 11491.54 EL.U/mL |
| 10PP-HD 1d Group | 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 | Anti-Ply 5 Mth post dose 2 | 7453.65 EL.U/mL |
| 10PP-HD 1d Group | 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 | Anti-Ply 3 Mth post dose 3 | 17933.07 EL.U/mL |
| 10PP-HD 1d Group | 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 | Anti-PhtD 1 Mth post dose 2 | 1264.57 EL.U/mL |
| 10PP-HD 1d Group | 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 | Anti-PhtD 5 Mth post dose 2 | 1448.08 EL.U/mL |
| 10PP-HD 1d Group | 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 | Anti-PhtD 3 Mth post dose 3 | 3250.91 EL.U/mL |
| Prevnar13 1d Group | 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 | Anti-PhtD 5 Mth post dose 2 | 1036.53 EL.U/mL |
| Prevnar13 1d Group | 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 | Anti-Ply 1 Mth post dose 2 | 488.79 EL.U/mL |
| Prevnar13 1d Group | 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 | Anti-PhtD 1 Mth post dose 2 | 368.62 EL.U/mL |
| Prevnar13 1d Group | 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 | Anti-Ply 5 Mth post dose 2 | 807.67 EL.U/mL |
| Prevnar13 1d Group | 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 | Anti-PhtD 3 Mth post dose 3 | 1654.79 EL.U/mL |
| Prevnar13 1d Group | 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 | Anti-Ply 3 Mth post dose 3 | 1114.25 EL.U/mL |
Secondary
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
Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | 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 | Anti-PhtD 5 Mth post dose 3 | 2242.06 EL.U/mL |
| 10PP-HD 1d Group | 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 | Anti-Ply 5 Mth post dose 3 | 11268.35 EL.U/mL |
| 10PP-HD 1d Group | 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 | Anti-PhtD 8 Mth post dose 3 | 2608.78 EL.U/mL |
| 10PP-HD 1d Group | 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 | Anti-Ply 8 Mth post dose 3 | 10512.39 EL.U/mL |
| 10PP-HD 1d Group | 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 | Anti-PhtD 1 Mth post dose 3 | 2584.28 EL.U/mL |
| 10PP-HD 1d Group | 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 | Anti-Ply 1 Mth post dose 3 | 13968.86 EL.U/mL |
| Prevnar13 1d Group | 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 | Anti-Ply 8 Mth post dose 3 | 10299.57 EL.U/mL |
| Prevnar13 1d Group | 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 | Anti-PhtD 5 Mth post dose 3 | 1498.86 EL.U/mL |
| Prevnar13 1d Group | 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 | Anti-PhtD 1 Mth post dose 3 | 2188.28 EL.U/mL |
| Prevnar13 1d Group | 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 | Anti-PhtD 8 Mth post dose 3 | 2078.35 EL.U/mL |
| Prevnar13 1d Group | 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 | Anti-Ply 1 Mth post dose 3 | 16771.16 EL.U/mL |
| Prevnar13 1d Group | 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 | Anti-Ply 5 Mth post dose 3 | 10817.78 EL.U/mL |
| Synflorix 3+0d Group | 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 | Anti-PhtD 5 Mth post dose 3 | 936.83 EL.U/mL |
| Synflorix 3+0d Group | 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 | Anti-Ply 5 Mth post dose 3 | 744.86 EL.U/mL |
| Synflorix 3+0d Group | 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 | Anti-PhtD 1 Mth post dose 3 | 334.18 EL.U/mL |
| Synflorix 3+0d Group | 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 | Anti-Ply 8 Mth post dose 3 | 999.39 EL.U/mL |
| Synflorix 3+0d Group | 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 | Anti-Ply 1 Mth post dose 3 | 451.32 EL.U/mL |
| Synflorix 3+0d Group | 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 | Anti-PhtD 8 Mth post dose 3 | 1667.91 EL.U/mL |
| Prevnar13 3+0d Group | 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 | Anti-PhtD 8 Mth post dose 3 | 2380.09 EL.U/mL |
| Prevnar13 3+0d Group | 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 | Anti-Ply 1 Mth post dose 3 | 419.47 EL.U/mL |
| Prevnar13 3+0d Group | 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 | Anti-Ply 5 Mth post dose 3 | 637.49 EL.U/mL |
| Prevnar13 3+0d Group | 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 | Anti-Ply 8 Mth post dose 3 | 884.83 EL.U/mL |
| Prevnar13 3+0d Group | 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 | Anti-PhtD 1 Mth post dose 3 | 486.01 EL.U/mL |
| Prevnar13 3+0d Group | 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 | Anti-PhtD 5 Mth post dose 3 | 1419.77 EL.U/mL |
Secondary
Antibody Concentrations Against Protein D (PD) - For Cohort 1/Step 1 Subjects
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.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10PP-HD 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 1/Step 1 Subjects | 137.5 LU/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 1/Step 1 Subjects | 65.1 LU/mL |
Secondary
Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | Anti-PD 3 Mth post dose 3 | 534.8 EL.U/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | Anti-PD 1 Mth post dose 2 | 990.9 EL.U/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | Anti-PD 5 Mth post dose 2 | 281.3 EL.U/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | Anti-PD 1 Mth post dose 2 | 1126.7 EL.U/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | Anti-PD 5 Mth post dose 2 | 313.0 EL.U/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | Anti-PD 3 Mth post dose 3 | 664.9 EL.U/mL |
Secondary
Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-PD 1 Mth post dose 3 | 1922.8 EL.U/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-PD 8 Mth post dose 3 | 324.3 EL.U/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-PD 5 Mth post dose 3 | 559.2 EL.U/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-PD 1 Mth post dose 3 | 1833.8 EL.U/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-PD 8 Mth post dose 3 | 288.2 EL.U/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-PD 5 Mth post dose 3 | 499.2 EL.U/mL |
| Synflorix 3+0d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-PD 5 Mth post dose 3 | 609.9 EL.U/mL |
| Synflorix 3+0d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-PD 1 Mth post dose 3 | 1990.2 EL.U/mL |
| Synflorix 3+0d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-PD 8 Mth post dose 3 | 344.2 EL.U/mL |
| Prevnar13 3+0d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-PD 1 Mth post dose 3 | 84.8 EL.U/mL |
| Prevnar13 3+0d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-PD 8 Mth post dose 3 | 69.2 EL.U/mL |
| Prevnar13 3+0d Group | Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-PD 5 Mth post dose 3 | 83.1 EL.U/mL |
Secondary
Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
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.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-6A 1 Mth post dose 2 | 0.11 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-6A 5 Mth post-dose 2 | 0.10 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-6A 3 Mth post dose 3 | 0.14 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-6A 1 Mth post dose 2 | 0.11 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-6A 5 Mth post-dose 2 | 0.12 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-6A 3 Mth post dose 3 | 0.15 µg/mL |
Secondary
Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
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.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-6A 5 Mth post dose 3 | 0.17 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-6A 1Mth post dose 3 | 0.13 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-6A 8 Mth post dose 3 | 0.16 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-6A 5 Mth post dose 3 | 0.15 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-6A 1Mth post dose 3 | 0.13 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-6A 8 Mth post dose 3 | 0.15 µg/mL |
| Synflorix 3+0d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-6A 5 Mth post dose 3 | 0.22 µg/mL |
| Synflorix 3+0d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-6A 1Mth post dose 3 | 0.13 µg/mL |
| Synflorix 3+0d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-6A 8 Mth post dose 3 | 0.18 µg/mL |
| Prevnar13 3+0d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-6A 5 Mth post dose 3 | 1.0 µg/mL |
| Prevnar13 3+0d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-6A 8 Mth post dose 3 | 0.59 µg/mL |
| Prevnar13 3+0d Group | Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-6A 1Mth post dose 3 | 3.01 µg/mL |
Secondary
Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 1/Step 1 Subjects
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.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Secondary
Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Secondary
Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Secondary
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
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.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-9V antibodies | 0.89 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-5 antibodies | 1.17 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-14 antibodies | 1.88 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-6B antibodies | 0.50 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-18C antibodies | 7.58 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-1 antibodies | 1.71 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-19F antibodies | 7.82 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-7F antibodies | 2.44 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-23F antibodies | 0.31 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-4 antibodies | 4.80 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-23F antibodies | 1.11 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-4 antibodies | 4.17 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-5 antibodies | 1.47 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-1 antibodies | 3.12 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-6B antibodies | 1.57 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-7F antibodies | 6.11 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-9V antibodies | 2.41 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-14 antibodies | 3.77 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-18C antibodies | 4.82 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | Anti-19F antibodies | 5.95 µg/mL |
Secondary
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
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.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | 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 | Anti-9V 1 Mth post dose 2 | 1.85 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-5 1 Mth post dose 2 | 3.74 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-9V 5 Mth post dose 2 | 0.85 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-1 3 Mth post dose 3 | 1.65 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-9V 3 Mth post dose 3 | 2.86 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-5 5 Mth post dose 2 | 1.07 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-14 1 Mth post dose 2 | 2.39 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-7F 3 Mth post dose 3 | 3.36 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-14 5 Mth post dose 2 | 0.85 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-5 3 Mth post dose 3 | 2.86 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-14 3 Mth post dose 3 | 2.40 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-4 1 Mth post dose 2 | 2.79 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-18C 1 Mth post dose 2 | 11.33 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-6B 1 Mth post dose 2 | 0.51 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-18C 5 Mth post dose 2 | 3.00 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-1 1 Mth post dose 2 | 2.52 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-18C 3 Mth post dose 3 | 18.38 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-6B 5 Mth post dose 2 | 0.63 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-19F 1 Mth post dose 2 | 7.33 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-4 5 Mth post dose 2 | 0.79 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-19F 5 Mth post dose 2 | 2.38 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-6B 3 Mth post dose 3 | 1.35 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-19F 3 Mth post dose 3 | 5.99 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-1 5 Mth post dose 2 | 0.44 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-23F 1 Mth post dose 2 | 0.63 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-7F 1 Mth post dose 2 | 3.29 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-23F 5 Mth post dose 2 | 0.44 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-4 3 Mth post dose 3 | 2.15 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-23F 3 Mth post dose 3 | 1.46 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-7F 5 Mth post dose 2 | 1.47 µg/mL |
| Prevnar13 1d Group | 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 | Anti-23F 3 Mth post dose 3 | 1.50 µg/mL |
| Prevnar13 1d Group | 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 | Anti-7F 5 Mth post dose 2 | 1.48 µg/mL |
| Prevnar13 1d Group | 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 | Anti-1 5 Mth post dose 2 | 0.42 µg/mL |
| Prevnar13 1d Group | 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 | Anti-1 3 Mth post dose 3 | 1.61 µg/mL |
| Prevnar13 1d Group | 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 | Anti-4 1 Mth post dose 2 | 2.67 µg/mL |
| Prevnar13 1d Group | 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 | Anti-4 5 Mth post dose 2 | 0.76 µg/mL |
| Prevnar13 1d Group | 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 | Anti-4 3 Mth post dose 3 | 1.92 µg/mL |
| Prevnar13 1d Group | 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 | Anti-5 1 Mth post dose 2 | 3.40 µg/mL |
| Prevnar13 1d Group | 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 | Anti-5 5 Mth post dose 2 | 0.92 µg/mL |
| Prevnar13 1d Group | 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 | Anti-5 3 Mth post dose 3 | 2.34 µg/mL |
| Prevnar13 1d Group | 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 | Anti-6B 1 Mth post dose 2 | 0.51 µg/mL |
| Prevnar13 1d Group | 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 | Anti-6B 5 Mth post dose 2 | 0.67 µg/mL |
| Prevnar13 1d Group | 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 | Anti-6B 3 Mth post dose 3 | 1.39 µg/mL |
| Prevnar13 1d Group | 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 | Anti-7F 1 Mth post dose 2 | 3.06 µg/mL |
| Prevnar13 1d Group | 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 | Anti-7F 3 Mth post dose 3 | 3.40 µg/mL |
| Prevnar13 1d Group | 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 | Anti-9V 1 Mth post dose 2 | 1.97 µg/mL |
| Prevnar13 1d Group | 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 | Anti-9V 5 Mth post dose 2 | 0.81 µg/mL |
| Prevnar13 1d Group | 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 | Anti-9V 3 Mth post dose 3 | 2.67 µg/mL |
| Prevnar13 1d Group | 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 | Anti-14 1 Mth post dose 2 | 2.29 µg/mL |
| Prevnar13 1d Group | 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 | Anti-14 5 Mth post dose 2 | 0.89 µg/mL |
| Prevnar13 1d Group | 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 | Anti-14 3 Mth post dose 3 | 2.42 µg/mL |
| Prevnar13 1d Group | 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 | Anti-18C 1 Mth post dose 2 | 10.88 µg/mL |
| Prevnar13 1d Group | 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 | Anti-18C 5 Mth post dose 2 | 3.18 µg/mL |
| Prevnar13 1d Group | 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 | Anti-18C 3 Mth post dose 3 | 16.24 µg/mL |
| Prevnar13 1d Group | 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 | Anti-19F 1 Mth post dose 2 | 7.85 µg/mL |
| Prevnar13 1d Group | 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 | Anti-19F 5 Mth post dose 2 | 2.48 µg/mL |
| Prevnar13 1d Group | 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 | Anti-19F 3 Mth post dose 3 | 6.27 µg/mL |
| Prevnar13 1d Group | 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 | Anti-23F 1 Mth post dose 2 | 0.67 µg/mL |
| Prevnar13 1d Group | 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 | Anti-23F 5 Mth post dose 2 | 0.46 µg/mL |
| Prevnar13 1d Group | 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 | Anti-1 1 Mth post dose 2 | 2.41 µg/mL |
Secondary
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
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.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | 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 | Anti-4 1 Mth post dose 3 | 3.89 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-5 5 Mth post dose 3 | 1.37 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-23F 8 Mth post dose 3 | 0.62 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-19F 5 Mth post dose 3 | 2.65 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-18C 8 Mth post dose 3 | 2.18 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-14 1 Mth post dose 3 | 4.36 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-1 1 Mth post dose 3 | 3.58 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-14 8 Mth post dose 3 | 1.38 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-7F 1 Mth post dose 3 | 4.63 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-19F 8 Mth post dose 3 | 1.65 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-1 5 Mth post dose 3 | 0.67 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-7F 8 Mth post dose 3 | 1.54 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-6B 1 Mth post dose 3 | 0.91 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-9V 8 Mth post dose 3 | 1.09 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-1 8 Mth post dose 3 | 0.40 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-5 8 Mth post dose 3 | 0.73 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-18C 1 Mth post dose 3 | 15.88 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-23F 1 Mth post dose 3 | 1.18 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-18C 5 Mth post dose 3 | 4.09 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-19F 1 Mth post dose 3 | 9.47 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-9V 5 Mth post dose 3 | 1.35 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-4 5 Mth post dose 3 | 1.19 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-7F 5 Mth post dose 3 | 2.24 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-14 5 Mth post dose 3 | 2.15 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-4 8 Mth post dose 3 | 0.70 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-23F 5 Mth post dose 3 | 0.78 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-6B 8 Mth post dose 3 | 0.87 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-9V 1 Mth post dose 3 | 3.23 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-5 1 Mth post dose 3 | 5.17 µg/mL |
| 10PP-HD 1d Group | 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 | Anti-6B 5 Mth post dose 3 | 1.10 µg/mL |
| Prevnar13 1d Group | 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 | Anti-5 1 Mth post dose 3 | 4.83 µg/mL |
| Prevnar13 1d Group | 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 | Anti-7F 8 Mth post dose 3 | 1.31 µg/mL |
| Prevnar13 1d Group | 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 | Anti-5 5 Mth post dose 3 | 1.25 µg/mL |
| Prevnar13 1d Group | 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 | Anti-5 8 Mth post dose 3 | 0.68 µg/mL |
| Prevnar13 1d Group | 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 | Anti-19F 5 Mth post dose 3 | 2.34 µg/mL |
| Prevnar13 1d Group | 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 | Anti-7F 5 Mth post dose 3 | 1.84 µg/mL |
| Prevnar13 1d Group | 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 | Anti-6B 1 Mth post dose 3 | 0.69 µg/mL |
| Prevnar13 1d Group | 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 | Anti-7F 1 Mth post dose 3 | 4.10 µg/mL |
| Prevnar13 1d Group | 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 | Anti-6B 8 Mth post dose 3 | 0.73 µg/mL |
| Prevnar13 1d Group | 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 | Anti-19F 8 Mth post dose 3 | 1.45 µg/mL |
| Prevnar13 1d Group | 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 | Anti-18C 5 Mth post dose 3 | 3.52 µg/mL |
| Prevnar13 1d Group | 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 | Anti-14 5 Mth post dose 3 | 1.86 µg/mL |
| Prevnar13 1d Group | 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 | Anti-23F 1 Mth post dose 3 | 1.14 µg/mL |
| Prevnar13 1d Group | 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 | Anti-4 5 Mth post dose 3 | 1.04 µg/mL |
| Prevnar13 1d Group | 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 | Anti-23F 5 Mth post dose 3 | 0.77 µg/mL |
| Prevnar13 1d Group | 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 | Anti-18C 1 Mth post dose 3 | 14.84 µg/mL |
| Prevnar13 1d Group | 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 | Anti-14 1 Mth post dose 3 | 4.11 µg/mL |
| Prevnar13 1d Group | 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 | Anti-23F 8 Mth post dose 3 | 0.59 µg/mL |
| Prevnar13 1d Group | 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 | Anti-1 1 Mth post dose 3 | 3.20 µg/mL |
| Prevnar13 1d Group | 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 | Anti-18C 8 Mth post dose 3 | 1.82 µg/mL |
| Prevnar13 1d Group | 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 | Anti-9V 8 Mth post dose 3 | 0.87 µg/mL |
| Prevnar13 1d Group | 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 | Anti-1 5 Mth post dose 3 | 0.55 µg/mL |
| Prevnar13 1d Group | 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 | Anti-6B 5 Mth post dose 3 | 0.86 µg/mL |
| Prevnar13 1d Group | 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 | Anti-1 8 Mth post dose 3 | 0.35 µg/mL |
| Prevnar13 1d Group | 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 | Anti-9V 5 Mth post dose 3 | 1.15 µg/mL |
| Prevnar13 1d Group | 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 | Anti-4 1 Mth post dose 3 | 3.15 µg/mL |
| Prevnar13 1d Group | 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 | Anti-19F 1 Mth post dose 3 | 9.36 µg/mL |
| Prevnar13 1d Group | 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 | Anti-9V 1 Mth post dose 3 | 3.25 µg/mL |
| Prevnar13 1d Group | 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 | Anti-4 8 Mth post dose 3 | 0.59 µg/mL |
| Prevnar13 1d Group | 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 | Anti-14 8 Mth post dose 3 | 1.37 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-6B 5 Mth post dose 3 | 1.24 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-18C 5 Mth post dose 3 | 4.17 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-18C 8 Mth post dose 3 | 2.24 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-19F 1 Mth post dose 3 | 10.04 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-19F 5 Mth post dose 3 | 3.11 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-19F 8 Mth post dose 3 | 1.99 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-23F 1 Mth post dose 3 | 1.22 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-23F 5 Mth post dose 3 | 0.90 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-23F 8 Mth post dose 3 | 0.68 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-1 1 Mth post dose 3 | 3.38 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-1 5 Mth post dose 3 | 0.62 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-1 8 Mth post dose 3 | 0.40 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-4 1 Mth post dose 3 | 3.75 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-4 5 Mth post dose 3 | 1.14 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-4 8 Mth post dose 3 | 0.66 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-5 1 Mth post dose 3 | 5.30 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-5 5 Mth post dose 3 | 1.33 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-5 8 Mth post dose 3 | 0.69 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-6B 1 Mth post dose 3 | 1.00 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-6B 8 Mth post dose 3 | 0.96 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-7F 1 Mth post dose 3 | 4.29 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-7F 5 Mth post dose 3 | 2.19 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-7F 8 Mth post dose 3 | 1.57 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-9V 1 Mth post dose 3 | 3.26 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-9V 5 Mth post dose 3 | 1.33 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-9V 8 Mth post dose 3 | 1.08 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-14 1 Mth post dose 3 | 4.15 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-14 5 Mth post dose 3 | 2.13 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-14 8 Mth post dose 3 | 1.42 µg/mL |
| Synflorix 3+0d Group | 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 | Anti-18C 1 Mth post dose 3 | 15.66 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-19F 5 Mth post dose 3 | 0.96 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-7F 8 Mth post dose 3 | 1.65 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-4 8 Mth post dose 3 | 0.54 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-4 5 Mth post dose 3 | 1.06 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-19F 1 Mth post dose 3 | 5.99 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-9V 1 Mth post dose 3 | 4.02 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-4 1 Mth post dose 3 | 6.25 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-1 8 Mth post dose 3 | 0.83 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-18C 1 Mth post dose 3 | 5.78 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-9V 5 Mth post dose 3 | 0.83 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-1 5 Mth post dose 3 | 1.16 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-1 1 Mth post dose 3 | 5.51 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-14 8 Mth post dose 3 | 2.47 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-9V 8 Mth post dose 3 | 0.63 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-23F 8 Mth post dose 3 | 0.39 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-23F 5 Mth post dose 3 | 0.47 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-18C 8 Mth post dose 3 | 0.66 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-14 1 Mth post dose 3 | 4.66 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-23F 1 Mth post dose 3 | 2.92 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-19F 8 Mth post dose 3 | 0.55 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-6B 8 Mth post dose 3 | 0.29 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-6B 5 Mth post dose 3 | 0.38 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-18C 5 Mth post dose 3 | 0.95 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-7F 1 Mth post dose 3 | 5.53 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-6B 1 Mth post dose 3 | 1.35 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-5 8 Mth post dose 3 | 1.12 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-14 5 Mth post dose 3 | 3.43 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-7F 5 Mth post dose 3 | 2.21 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-5 5 Mth post dose 3 | 1.79 µg/mL |
| Prevnar13 3+0d Group | 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 | Anti-5 1 Mth post dose 3 | 7.02 µg/mL |
Secondary
Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects
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.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | Anti-3 antibodies | 0.25 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | Anti-6A antibodies | 0.18 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | Anti-19A antibodies | 1.38 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | Anti-3 antibodies | 2.35 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | Anti-6A antibodies | 1.36 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | Anti-19A antibodies | 5.51 µg/mL |
Secondary
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
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.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-3 1 Mth post dose 2 | 0.04 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-3 5 Mth post dose 2 | 0.06 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-3 3 Mth post dose 3 | 0.07 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-19A 1 Mth post dose 2 | 0.24 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-19A 5 Mth post dose 2 | 0.18 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-19A 3 Mth post dose 3 | 0.56 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-19A 5 Mth post dose 2 | 0.19 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-3 1 Mth post dose 2 | 0.05 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-19A 1 Mth post dose 2 | 0.25 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-3 5 Mth post dose 2 | 0.07 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-19A 3 Mth post dose 3 | 0.64 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule | Anti-3 3 Mth post dose 3 | 0.08 µg/mL |
Secondary
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
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.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-3 5 Mth post dose 3 | 0.06 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-19A 5 Mth post dose 3 | 0.21 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-3 1 Mth post dose 3 | 0.05 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-19A 1 Mth post dose 3 | 0.24 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-3 8 Mth post dose 3 | 0.08 µg/mL |
| 10PP-HD 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-19A 8 Mth post dose 3 | 0.24 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-3 8 Mth post dose 3 | 0.09 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-19A 1 Mth post dose 3 | 0.20 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-19A 8 Mth post dose 3 | 0.21 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-3 5 Mth post dose 3 | 0.06 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-19A 5 Mth post dose 3 | 0.17 µg/mL |
| Prevnar13 1d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-3 1 Mth post dose 3 | 0.05 µg/mL |
| Synflorix 3+0d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-19A 1 Mth post dose 3 | 0.23 µg/mL |
| Synflorix 3+0d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-3 1 Mth post dose 3 | 0.05 µg/mL |
| Synflorix 3+0d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-3 5 Mth post dose 3 | 0.07 µg/mL |
| Synflorix 3+0d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-3 8 Mth post dose 3 | 0.09 µg/mL |
| Synflorix 3+0d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-19A 5 Mth post dose 3 | 0.24 µg/mL |
| Synflorix 3+0d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-19A 8 Mth post dose 3 | 0.27 µg/mL |
| Prevnar13 3+0d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-3 5 Mth post dose 3 | 0.60 µg/mL |
| Prevnar13 3+0d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-19A 8 Mth post dose 3 | 0.64 µg/mL |
| Prevnar13 3+0d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-3 1 Mth post dose 3 | 4.52 µg/mL |
| Prevnar13 3+0d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-19A 5 Mth post dose 3 | 0.91 µg/mL |
| Prevnar13 3+0d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-19A 1 Mth post dose 3 | 5.27 µg/mL |
| Prevnar13 3+0d Group | Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule | Anti-3 8 Mth post dose 3 | 0.32 µg/mL |
Secondary
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
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.
Time frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | 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 | Anti-Polio 1 - 1 Mth post dose 2 | 330.3 Titers |
| 10PP-HD 1d Group | 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 | Anti-Polio 2 - 1 Mth post dose 2 | 486.7 Titers |
| 10PP-HD 1d Group | 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 | Anti-Polio 3 - 1 Mth post dose 2 | 106.9 Titers |
| Prevnar13 1d Group | 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 | Anti-Polio 2 - 1 Mth post dose 2 | 702.9 Titers |
| Prevnar13 1d Group | 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 | Anti-Polio 1 - 1 Mth post dose 2 | 415.6 Titers |
| Prevnar13 1d Group | 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 | Anti-Polio 3 - 1 Mth post dose 2 | 181.1 Titers |
Secondary
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
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.
Time frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | 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 | Anti-Polio 3 - 1 Mth post dose 3 | 135.4 Titers |
| 10PP-HD 1d Group | 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 | Anti-Polio 1 - 1 Mth post dose 3 | 413.2 Titers |
| 10PP-HD 1d Group | 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 | Anti-Polio 2 - 1 Mth post dose 3 | 545.8 Titers |
| Prevnar13 1d Group | 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 | Anti-Polio 2 - 1 Mth post dose 3 | 619.5 Titers |
| Prevnar13 1d Group | 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 | Anti-Polio 1 - 1 Mth post dose 3 | 314.8 Titers |
| Prevnar13 1d Group | 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 | Anti-Polio 3 - 1 Mth post dose 3 | 166.0 Titers |
| Synflorix 3+0d Group | 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 | Anti-Polio 3 - 1 Mth post dose 3 | 110.1 Titers |
| Synflorix 3+0d Group | 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 | Anti-Polio 1 - 1 Mth post dose 3 | 447.9 Titers |
| Synflorix 3+0d Group | 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 | Anti-Polio 2 - 1 Mth post dose 3 | 514.2 Titers |
| Prevnar13 3+0d Group | 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 | Anti-Polio 2 - 1 Mth post dose 3 | 536.9 Titers |
| Prevnar13 3+0d Group | 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 | Anti-Polio 1 - 1 Mth post dose 3 | 398.3 Titers |
| Prevnar13 3+0d Group | 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 | Anti-Polio 3 - 1 Mth post dose 3 | 191.8 Titers |
Secondary
Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.
Time frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10PP-HD 1d Group | Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 123.2 EL.U/mL |
| Prevnar13 1d Group | Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 114.7 EL.U/mL |
Secondary
Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.
Time frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10PP-HD 1d Group | Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 111.9 EL.U/mL |
| Prevnar13 1d Group | Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 110.3 EL.U/mL |
| Synflorix 3+0d Group | Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 105.8 EL.U/mL |
| Prevnar13 3+0d Group | Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 117.0 EL.U/mL |
Secondary
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.
Time frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | Anti-D 1 Mth post dose 2 | 2.591 IU/mL |
| 10PP-HD 1d Group | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | Anti-T 1 Mth post dose 2 | 5.714 IU/mL |
| Prevnar13 1d Group | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | Anti-D 1 Mth post dose 2 | 2.560 IU/mL |
| Prevnar13 1d Group | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | Anti-T 1 Mth post dose 2 | 4.738 IU/mL |
Secondary
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.
Time frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-D 1 Mth post dose 3 | 2.499 IU/mL |
| 10PP-HD 1d Group | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-T 1 Mth post dose 3 | 4.977 IU/mL |
| Prevnar13 1d Group | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-T 1 Mth post dose 3 | 5.113 IU/mL |
| Prevnar13 1d Group | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-D 1 Mth post dose 3 | 2.696 IU/mL |
| Synflorix 3+0d Group | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-D 1 Mth post dose 3 | 2.874 IU/mL |
| Synflorix 3+0d Group | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-T 1 Mth post dose 3 | 4.709 IU/mL |
| Prevnar13 3+0d Group | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-D 1 Mth post dose 3 | 1.531 IU/mL |
| Prevnar13 3+0d Group | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | Anti-T 1 Mth post dose 3 | 4.047 IU/mL |
Secondary
Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.
Time frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10PP-HD 1d Group | Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 1318.5 mIU/mL |
| Prevnar13 1d Group | Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 976.5 mIU/mL |
Secondary
Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.
Time frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10PP-HD 1d Group | Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 1235.8 mIU/mL |
| Prevnar13 1d Group | Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 1165.8 mIU/mL |
| Synflorix 3+0d Group | Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 990.1 mIU/mL |
| Prevnar13 3+0d Group | Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 1206.6 mIU/mL |
Secondary
Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.
Time frame: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10PP-HD 1d Group | Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 284.5 mIU/mL |
| Prevnar13 1d Group | Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 305.9 mIU/mL |
Secondary
Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.
Time frame: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10PP-HD 1d Group | Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 329.2 mIU/mL |
| Prevnar13 1d Group | Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 298.6 mIU/mL |
| Synflorix 3+0d Group | Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 295.8 mIU/mL |
| Prevnar13 3+0d Group | Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 274.1 mIU/mL |
Secondary
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Time frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10PP-HD 1d Group | Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 21.274 µg/mL |
| Prevnar13 1d Group | Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 21.150 µg/mL |
Secondary
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Time frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10PP-HD 1d Group | Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 23.381 µg/mL |
| Prevnar13 1d Group | Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 19.397 µg/mL |
| Synflorix 3+0d Group | Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 19.239 µg/mL |
| Prevnar13 3+0d Group | Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 18.981 µg/mL |
Secondary
Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 1/Step 1 Subjects
Concentrations of Hem-Ply antibodies were expressed as geometric mean titers . The cut-off of the assay was an Hem-Ply antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10PP-HD 1d Group | Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 1/Step 1 Subjects | 682.3 Titers |
| Prevnar13 1d Group | Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 1/Step 1 Subjects | 534.0 Titers |
Secondary
Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Secondary
Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Secondary
Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 136 Participants |
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 136 Participants |
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 144 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 141 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 155 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 131 Participants |
Secondary
Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 128 Participants |
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 139 Participants |
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 136 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 130 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 130 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 128 Participants |
| Synflorix 3+0d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 145 Participants |
| Synflorix 3+0d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 136 Participants |
| Synflorix 3+0d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 142 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 135 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 142 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 133 Participants |
Secondary
Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 9 Participants |
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 12 Participants |
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 20 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 25 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 12 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 8 Participants |
Secondary
Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 17 Participants |
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 9 Participants |
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 24 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 21 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 10 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 23 Participants |
| Synflorix 3+0d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 25 Participants |
| Synflorix 3+0d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 16 Participants |
| Synflorix 3+0d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 10 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 19 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 6 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 24 Participants |
Secondary
Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 117 Participants |
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 119 Participants |
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 129 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 117 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 128 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 138 Participants |
Secondary
Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 124 Participants |
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 121 Participants |
| 10PP-HD 1d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 108 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 106 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 115 Participants |
| Prevnar13 1d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 122 Participants |
| Synflorix 3+0d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 131 Participants |
| Synflorix 3+0d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 120 Participants |
| Synflorix 3+0d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 122 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 112 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 122 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 126 Participants |
Secondary
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
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.
Time frame: Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | 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 | Grade 3 Drowsiness | 0 Participants |
| 10PP-HD 1d Group | 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 | Any Irritability/fussiness | 27 Participants |
| 10PP-HD 1d Group | 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 | Any Fever | 32 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Irritability/fussiness | 0 Participants |
| 10PP-HD 1d Group | 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 | Any Drowsiness | 12 Participants |
| 10PP-HD 1d Group | 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 | Related Irritability/fussiness | 27 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Fever | 0 Participants |
| 10PP-HD 1d Group | 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 | Any Loss of appetite | 3 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Loss of appetite | 0 Participants |
| 10PP-HD 1d Group | 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 | Related Drowsiness | 12 Participants |
| 10PP-HD 1d Group | 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 | Related Loss of appetite | 3 Participants |
| 10PP-HD 1d Group | 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 | Related Fever | 30 Participants |
| Prevnar13 1d Group | 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 | Related Loss of appetite | 4 Participants |
| Prevnar13 1d Group | 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 | Any Drowsiness | 4 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Drowsiness | 0 Participants |
| Prevnar13 1d Group | 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 | Related Drowsiness | 4 Participants |
| Prevnar13 1d Group | 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 | Any Fever | 27 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Fever | 1 Participants |
| Prevnar13 1d Group | 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 | Related Fever | 25 Participants |
| Prevnar13 1d Group | 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 | Any Irritability/fussiness | 19 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Irritability/fussiness | 0 Participants |
| Prevnar13 1d Group | 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 | Related Irritability/fussiness | 19 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Loss of appetite | 0 Participants |
| Prevnar13 1d Group | 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 | Any Loss of appetite | 5 Participants |
Secondary
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
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.
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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | 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 | Any Drowsiness | 47 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Drowsiness | 0 Participants |
| 10PP-HD 1d Group | 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 | Related Drowsiness | 46 Participants |
| 10PP-HD 1d Group | 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 | Any Fever | 92 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Fever | 0 Participants |
| 10PP-HD 1d Group | 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 | Related Fever | 89 Participants |
| 10PP-HD 1d Group | 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 | Any Irritability/fussiness | 131 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Irritability/fussiness | 1 Participants |
| 10PP-HD 1d Group | 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 | Related Irritability/fussiness | 128 Participants |
| 10PP-HD 1d Group | 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 | Any Loss of appetite | 24 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Loss of appetite | 0 Participants |
| 10PP-HD 1d Group | 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 | Related Loss of appetite | 24 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Loss of appetite | 0 Participants |
| Prevnar13 1d Group | 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 | Any Drowsiness | 44 Participants |
| Prevnar13 1d Group | 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 | Any Irritability/fussiness | 128 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Drowsiness | 0 Participants |
| Prevnar13 1d Group | 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 | Any Loss of appetite | 25 Participants |
| Prevnar13 1d Group | 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 | Related Drowsiness | 43 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Irritability/fussiness | 2 Participants |
| Prevnar13 1d Group | 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 | Any Fever | 84 Participants |
| Prevnar13 1d Group | 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 | Related Loss of appetite | 24 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Fever | 0 Participants |
| Prevnar13 1d Group | 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 | Related Irritability/fussiness | 126 Participants |
| Prevnar13 1d Group | 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 | Related Fever | 84 Participants |
Secondary
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
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.
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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | 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 | Any Fever | 104 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Fever | 0 Participants |
| 10PP-HD 1d Group | 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 | Related Drowsiness | 43 Participants |
| 10PP-HD 1d Group | 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 | Related Fever | 102 Participants |
| 10PP-HD 1d Group | 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 | Any Drowsiness | 43 Participants |
| 10PP-HD 1d Group | 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 | Any Irritability/fussiness | 139 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Irritability/fussiness | 6 Participants |
| 10PP-HD 1d Group | 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 | Related Irritability/fussiness | 138 Participants |
| 10PP-HD 1d Group | 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 | Any Loss of appetite | 32 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Loss of appetite | 0 Participants |
| 10PP-HD 1d Group | 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 | Grade 3 Drowsiness | 0 Participants |
| 10PP-HD 1d Group | 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 | Related Loss of appetite | 32 Participants |
| Prevnar13 1d Group | 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 | Related Drowsiness | 45 Participants |
| Prevnar13 1d Group | 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 | Related Loss of appetite | 29 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Loss of appetite | 0 Participants |
| Prevnar13 1d Group | 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 | Any Irritability/fussiness | 133 Participants |
| Prevnar13 1d Group | 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 | Any Drowsiness | 46 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Irritability/fussiness | 4 Participants |
| Prevnar13 1d Group | 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 | Related Irritability/fussiness | 132 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Drowsiness | 0 Participants |
| Prevnar13 1d Group | 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 | Any Fever | 100 Participants |
| Prevnar13 1d Group | 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 | Any Loss of appetite | 30 Participants |
| Prevnar13 1d Group | 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 | Grade 3 Fever | 0 Participants |
| Prevnar13 1d Group | 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 | Related Fever | 100 Participants |
| Synflorix 3+0d Group | 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 | Any Loss of appetite | 27 Participants |
| Synflorix 3+0d Group | 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 | Related Irritability/fussiness | 138 Participants |
| Synflorix 3+0d Group | 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 | Any Fever | 105 Participants |
| Synflorix 3+0d Group | 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 | Grade 3 Drowsiness | 0 Participants |
| Synflorix 3+0d Group | 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 | Any Irritability/fussiness | 141 Participants |
| Synflorix 3+0d Group | 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 | Related Drowsiness | 38 Participants |
| Synflorix 3+0d Group | 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 | Grade 3 Loss of appetite | 1 Participants |
| Synflorix 3+0d Group | 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 | Related Fever | 104 Participants |
| Synflorix 3+0d Group | 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 | Grade 3 Irritability/fussiness | 4 Participants |
| Synflorix 3+0d Group | 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 | Any Drowsiness | 38 Participants |
| Synflorix 3+0d Group | 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 | Related Loss of appetite | 26 Participants |
| Synflorix 3+0d Group | 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 | Grade 3 Fever | 0 Participants |
| Prevnar13 3+0d Group | 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 | Related Fever | 104 Participants |
| Prevnar13 3+0d Group | 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 | Related Irritability/fussiness | 136 Participants |
| Prevnar13 3+0d Group | 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 | Any Drowsiness | 44 Participants |
| Prevnar13 3+0d Group | 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 | Related Drowsiness | 43 Participants |
| Prevnar13 3+0d Group | 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 | Any Irritability/fussiness | 136 Participants |
| Prevnar13 3+0d Group | 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 | Grade 3 Irritability/fussiness | 7 Participants |
| Prevnar13 3+0d Group | 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 | Any Loss of appetite | 34 Participants |
| Prevnar13 3+0d Group | 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 | Grade 3 Loss of appetite | 0 Participants |
| Prevnar13 3+0d Group | 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 | Related Loss of appetite | 34 Participants |
| Prevnar13 3+0d Group | 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 | Any Fever | 106 Participants |
| Prevnar13 3+0d Group | 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 | Grade 3 Fever | 0 Participants |
| Prevnar13 3+0d Group | 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 | Grade 3 Drowsiness | 0 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
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.
Time frame: Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Grade 3 redness | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Grade 3 pain | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Any swelling | 4 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Any redness | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Grade 3 swelling | 1 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Any pain | 21 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Grade 3 swelling | 3 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Grade 3 pain | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Any redness | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Grade 3 redness | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Any swelling | 8 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Any pain | 26 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
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.
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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Any pain | 97 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Grade 3 pain | 1 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Any redness | 3 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Grade 3 redness | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Any swelling | 35 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Grade 3 swelling | 9 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Any swelling | 31 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Any pain | 102 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Grade 3 redness | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Grade 3 pain | 1 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Grade 3 swelling | 4 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. | Any redness | 5 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.
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.
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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Grade 3 pain | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Any redness | 8 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Grade 3 swelling | 7 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Any swelling | 30 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Any pain | 108 Participants |
| 10PP-HD 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Grade 3 redness | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Any pain | 121 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Grade 3 pain | 1 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Any redness | 7 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Grade 3 redness | 1 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Any swelling | 45 Participants |
| Prevnar13 1d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Grade 3 swelling | 10 Participants |
| Synflorix 3+0d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Any swelling | 40 Participants |
| Synflorix 3+0d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Grade 3 redness | 1 Participants |
| Synflorix 3+0d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Grade 3 pain | 0 Participants |
| Synflorix 3+0d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Any pain | 123 Participants |
| Synflorix 3+0d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Any redness | 9 Participants |
| Synflorix 3+0d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Grade 3 swelling | 17 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Any redness | 5 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Grade 3 swelling | 7 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Grade 3 redness | 0 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Any swelling | 37 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Grade 3 pain | 0 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. | Any pain | 115 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule
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.
Time frame: From Day 0 to Month 10
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule | 4 Participants |
| Prevnar13 1d Group | Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule | 5 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule
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.
Time frame: From Day 0 to Month 10
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule | 1 Participants |
| Prevnar13 1d Group | Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule | 4 Participants |
| Synflorix 3+0d Group | Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule | 3 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule | 2 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule
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.
Time frame: Within the 31-day (Days 0-30) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule | 7 Participants |
| Prevnar13 1d Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule | 2 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule
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.
Time frame: Within the 31-day (Days 0-30) periods post vaccination with the first 2 doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule | 84 Participants |
| Prevnar13 1d Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule | 95 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule
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.
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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule | 113 Participants |
| Prevnar13 1d Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule | 114 Participants |
| Synflorix 3+0d Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule | 123 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule | 114 Participants |
Secondary
Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 6 Participants |
| 10PP-HD 1d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 2 Participants |
| 10PP-HD 1d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 5 Participants |
| Prevnar13 1d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 4 Participants |
| Prevnar13 1d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 4 Participants |
| Prevnar13 1d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 2 Participants |
Secondary
Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed.This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 5 Participants |
| 10PP-HD 1d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 4 Participants |
| 10PP-HD 1d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 4 Participants |
| Prevnar13 1d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 4 Participants |
| Prevnar13 1d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 6 Participants |
| Prevnar13 1d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 3 Participants |
| Synflorix 3+0d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 4 Participants |
| Synflorix 3+0d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 5 Participants |
| Synflorix 3+0d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 7 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 4 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 6 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 1 Participants |
Secondary
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
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.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | ALT - Status: Above | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Hgb - Status: Below | 2 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | WBC - Status: Unknown | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Hgb - Status: Within | 57 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | CREA - Status: Unknown | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Hgb - Status: Above | 1 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | ALT - Status: Below | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Platelets - Status: Unknown | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | CREA - Status: Below | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Platelets - Status: Below | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | WBC - Status: Within | 60 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Platelets - Status: Within | 59 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | CREA - Status: Within | 60 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Platelets - Status: Above | 1 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | ALT - Status: Within | 60 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | WBC - Status: Below | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | CREA - Status: Above | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | ALT - Status: Unknown | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | WBC - Status: Above | 0 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Hgb - Status: Unknown | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | WBC - Status: Above | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | ALT - Status: Unknown | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | ALT - Status: Below | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | ALT - Status: Within | 57 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | ALT - Status: Above | 3 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | CREA - Status: Unknown | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | CREA - Status: Below | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | CREA - Status: Within | 60 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | CREA - Status: Above | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Hgb - Status: Unknown | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Hgb - Status: Below | 2 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Hgb - Status: Within | 56 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Hgb - Status: Above | 2 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Platelets - Status: Unknown | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Platelets - Status: Below | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Platelets - Status: Within | 60 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | WBC - Status: Unknown | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | WBC - Status: Below | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | WBC - Status: Within | 60 Participants |
| Prevnar13 1d Group | Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects | Platelets - Status: Above | 0 Participants |
Secondary
Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 26 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 20 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 9 Participants |
| Prevnar13 1d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 23 Participants |
| Prevnar13 1d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 32 Participants |
| Prevnar13 1d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 11 Participants |
Secondary
Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 9 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 29 Participants |
| 10PP-HD 1d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 27 Participants |
| Prevnar13 1d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 28 Participants |
| Prevnar13 1d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 33 Participants |
| Prevnar13 1d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 13 Participants |
| Synflorix 3+0d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 28 Participants |
| Synflorix 3+0d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 28 Participants |
| Synflorix 3+0d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 12 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 37 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 9 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 30 Participants |
Secondary
Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 73 Participants |
| 10PP-HD 1d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 86 Participants |
| 10PP-HD 1d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 56 Participants |
| Prevnar13 1d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 93 Participants |
| Prevnar13 1d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 84 Participants |
| Prevnar13 1d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 83 Participants |
Secondary
Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 72 Participants |
| 10PP-HD 1d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 74 Participants |
| 10PP-HD 1d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 88 Participants |
| Prevnar13 1d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 98 Participants |
| Prevnar13 1d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 67 Participants |
| Prevnar13 1d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 73 Participants |
| Synflorix 3+0d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 104 Participants |
| Synflorix 3+0d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 78 Participants |
| Synflorix 3+0d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 70 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 100 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 74 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 88 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) - For Step 1/Cohort 1 Subjects
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.
Time frame: From Day 0 to Month 6
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Serious Adverse Events (SAEs) - For Step 1/Cohort 1 Subjects | 0 Participants |
| Prevnar13 1d Group | Number of Subjects With Serious Adverse Events (SAEs) - For Step 1/Cohort 1 Subjects | 0 Participants |
Secondary
Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 46 Participants |
| 10PP-HD 1d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 32 Participants |
| 10PP-HD 1d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 21 Participants |
| Prevnar13 1d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 62 Participants |
| Prevnar13 1d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 40 Participants |
| Prevnar13 1d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 17 Participants |
Secondary
Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 44 Participants |
| 10PP-HD 1d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 13 Participants |
| 10PP-HD 1d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 36 Participants |
| Prevnar13 1d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 44 Participants |
| Prevnar13 1d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 17 Participants |
| Prevnar13 1d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 37 Participants |
| Synflorix 3+0d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 39 Participants |
| Synflorix 3+0d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 54 Participants |
| Synflorix 3+0d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 25 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 50 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 11 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 37 Participants |
Secondary
Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (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.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 18 Participants |
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 27 Participants |
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 24 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 19 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 24 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 23 Participants |
Secondary
Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (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.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 24 Participants |
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 24 Participants |
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 25 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 15 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 23 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 31 Participants |
| Synflorix 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 34 Participants |
| Synflorix 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 28 Participants |
| Synflorix 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 16 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 21 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 29 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 30 Participants |
Secondary
Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 159 Participants |
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 164 Participants |
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 178 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 162 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 173 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 176 Participants |
Secondary
Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 165 Participants |
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 174 Participants |
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 166 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 158 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 166 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 161 Participants |
| Synflorix 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 176 Participants |
| Synflorix 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 166 Participants |
| Synflorix 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 174 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 155 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 171 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 168 Participants |
Secondary
Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 62 Participants |
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 45 Participants |
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 58 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 1 Mth post-dose 2 | 50 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 5 Mth post-dose 2 | 49 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | At 3 Mth post-dose 3 | 52 Participants |
Secondary
Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 57 Participants |
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 45 Participants |
| 10PP-HD 1d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 54 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 56 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 42 Participants |
| Prevnar13 1d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 48 Participants |
| Synflorix 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 58 Participants |
| Synflorix 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 60 Participants |
| Synflorix 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 47 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 1 Mth post dose 3 | 48 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 8 Mth post dose 3 | 42 Participants |
| Prevnar13 3+0d Group | Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | At 5 Mth post dose 3 | 46 Participants |
Secondary
Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-19A 3 Mth post dose 3 | 274.2 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-19A 1 Mth post dose 2 | 231.3 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-19A 5 Mth post dose 2 | 99.1 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-19A 1 Mth post dose 2 | 177.4 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-19A 5 Mth post dose 2 | 107.4 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-19A 3 Mth post dose 3 | 361.2 Titers |
Secondary
Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-19A 8 Mth post dose 3 | 155.2 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-19A 1 Mth post dose 3 | 347.0 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-19A 5 Mth post dose 3 | 120.4 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-19A 1 Mth post dose 3 | 281.1 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-19A 8 Mth post dose 3 | 151.5 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-19A 5 Mth post dose 3 | 121.6 Titers |
| Synflorix 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-19A 5 Mth post dose 3 | 140.2 Titers |
| Synflorix 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-19A 1 Mth post dose 3 | 369.8 Titers |
| Synflorix 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-19A 8 Mth post dose 3 | 138.7 Titers |
| Prevnar13 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-19A 1 Mth post dose 3 | 2652.8 Titers |
| Prevnar13 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-19A 8 Mth post dose 3 | 394.4 Titers |
| Prevnar13 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-19A 5 Mth post dose 3 | 704.2 Titers |
Secondary
Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 1/Step 1 Subjects
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.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Secondary
Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
No analysis was performed on opsonophagocytic activity for Antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Secondary
Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Secondary
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
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.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-1 | 17.2 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-4 | 2818.9 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-5 | 9.0 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-6B | 345.3 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-7F | 6214.0 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-9V | 2880.8 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-14 | 1116.1 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-18C | 3955.4 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-19F | 862.9 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-23F | 2756.7 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-18C | 2799.8 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-1 | 112.8 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-9V | 12687.8 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-4 | 4162.3 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-23F | 12652.4 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-5 | 89.8 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-14 | 5985.9 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-6B | 5082.5 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-19F | 452.8 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects | OPSONO-7F | 17781.0 Titers |
Secondary
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
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.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | 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 | OPSONO-7F 5 Mth post dose 2 | 1258.2 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-5 1 Mth post dose 2 | 49.1 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-7F 3 Mth post dose 3 | 2767.6 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-23F 3 Mth post dose 3 | 612.2 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-9V 1 Mth post dose 2 | 783.7 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-5 5 Mth post dose 2 | 11.8 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-9V 5 Mth post dose 2 | 241.3 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-4 1 Mth post dose 2 | 461.9 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-9V 3 Mth post dose 3 | 1044.3 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-5 3 Mth post dose 3 | 58.2 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-14 1 Mth post dose 2 | 349.7 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-1 5 Mth post dose 2 | 7.7 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-14 5 Mth post dose 2 | 54.3 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-6B 1 Mth post dose 2 | 359.8 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-14 3 Mth post dose 3 | 335.9 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-4 5 Mth post dose 2 | 27.0 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-18C 1 Mth post dose 2 | 464.7 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-6B 5 Mth post dose 2 | 159.1 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-18C 5 Mth post dose 2 | 28.4 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-1 1 Mth post dose 2 | 67.3 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-18C 3 Mth post dose 3 | 562.8 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-6B 3 Mth post dose 3 | 214.7 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-19F 5 Mth post dose 2 | 35.5 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-4 3 Mth post dose 3 | 260.0 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-19F 3 Mth post dose 3 | 203.6 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-7F 1 Mth post dose 2 | 2643.3 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-23F 1 Mth post dose 2 | 539.6 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-1 3 Mth post dose 3 | 58.8 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-23F 5 Mth post dose 2 | 156.5 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-19F 1 Mth post dose 2 | 299.3 Titers |
| Prevnar13 1d Group | 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 | OPSONO-23F 5 Mth post dose 2 | 158.6 Titers |
| Prevnar13 1d Group | 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 | OPSONO-19F 1 Mth post dose 2 | 284.7 Titers |
| Prevnar13 1d Group | 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 | OPSONO-23F 3 Mth post dose 3 | 835.7 Titers |
| Prevnar13 1d Group | 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 | OPSONO-1 1 Mth post dose 2 | 58.0 Titers |
| Prevnar13 1d Group | 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 | OPSONO-1 5 Mth post dose 2 | 8.1 Titers |
| Prevnar13 1d Group | 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 | OPSONO-1 3 Mth post dose 3 | 57.5 Titers |
| Prevnar13 1d Group | 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 | OPSONO-4 1 Mth post dose 2 | 427.2 Titers |
| Prevnar13 1d Group | 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 | OPSONO-4 5 Mth post dose 2 | 27.4 Titers |
| Prevnar13 1d Group | 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 | OPSONO-4 3 Mth post dose 3 | 241.1 Titers |
| Prevnar13 1d Group | 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 | OPSONO-5 1 Mth post dose 2 | 49.1 Titers |
| Prevnar13 1d Group | 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 | OPSONO-5 5 Mth post dose 2 | 12.6 Titers |
| Prevnar13 1d Group | 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 | OPSONO-5 3 Mth post dose 3 | 47.0 Titers |
| Prevnar13 1d Group | 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 | OPSONO-6B 1 Mth post dose 2 | 331.7 Titers |
| Prevnar13 1d Group | 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 | OPSONO-6B 5 Mth post dose 2 | 111.1 Titers |
| Prevnar13 1d Group | 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 | OPSONO-6B 3 Mth post dose 3 | 192.0 Titers |
| Prevnar13 1d Group | 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 | OPSONO-7F 1 Mth post dose 2 | 2336.3 Titers |
| Prevnar13 1d Group | 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 | OPSONO-7F 5 Mth post dose 2 | 1466.4 Titers |
| Prevnar13 1d Group | 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 | OPSONO-7F 3 Mth post dose 3 | 2963.6 Titers |
| Prevnar13 1d Group | 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 | OPSONO-9V 1 Mth post dose 2 | 763.2 Titers |
| Prevnar13 1d Group | 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 | OPSONO-9V 5 Mth post dose 2 | 163.3 Titers |
| Prevnar13 1d Group | 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 | OPSONO-9V 3 Mth post dose 3 | 712.4 Titers |
| Prevnar13 1d Group | 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 | OPSONO-14 1 Mth post dose 2 | 310.5 Titers |
| Prevnar13 1d Group | 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 | OPSONO-14 5 Mth post dose 2 | 40.2 Titers |
| Prevnar13 1d Group | 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 | OPSONO-14 3 Mth post dose 3 | 254.6 Titers |
| Prevnar13 1d Group | 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 | OPSONO-18C 1 Mth post dose 2 | 459.7 Titers |
| Prevnar13 1d Group | 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 | OPSONO-18C 5 Mth post dose 2 | 33.6 Titers |
| Prevnar13 1d Group | 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 | OPSONO-18C 3 Mth post dose 3 | 522.0 Titers |
| Prevnar13 1d Group | 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 | OPSONO-19F 5 Mth post dose 2 | 38.7 Titers |
| Prevnar13 1d Group | 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 | OPSONO-19F 3 Mth post dose 3 | 168.1 Titers |
| Prevnar13 1d Group | 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 | OPSONO-23F 1 Mth post dose 2 | 493.9 Titers |
Secondary
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
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.
Time frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | 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 | OPSONO-23F 8 Mth post dose 3 | 306.2 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-7F 8 Mth post dose 3 | 2001.5 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-7F 5 Mth post dose 3 | 2072.1 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-19F 8 Mth post dose 3 | 22.0 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-7F 1 Mth post dose 3 | 3755.3 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-6B 8 Mth post dose 3 | 146.9 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-5 8 Mth post dose 3 | 9.4 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-1 1 Mth post dose 3 | 136.3 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-4 5 Mth post dose 3 | 86.0 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-6B 5 Mth post dose 3 | 242.4 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-6B 1 Mth post dose 3 | 827.6 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-23F 5 Mth post dose 3 | 307.4 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-19F 5 Mth post dose 3 | 47.2 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-19F 1 Mth post dose 3 | 420.3 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-1 5 Mth post dose 3 | 14.1 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-4 8 Mth post dose 3 | 48.2 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-18C 8 Mth post dose 3 | 13.6 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-18C 5 Mth post dose 3 | 39.8 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-1 8 Mth post dose 3 | 10.0 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-5 5 Mth post dose 3 | 19.7 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-18C 1 Mth post dose 3 | 666.2 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-14 8 Mth post dose 3 | 152.9 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-4 1 Mth post dose 3 | 835.0 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-23F 1 Mth post dose 3 | 1421.3 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-14 5 Mth post dose 3 | 188.9 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-14 1 Mth post dose 3 | 1176.2 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-9V 8 Mth post dose 3 | 330.6 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-9V 5 Mth post dose 3 | 360.3 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-9V 1 Mth post dose 3 | 909.2 Titers |
| 10PP-HD 1d Group | 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 | OPSONO-5 1 Mth post dose 3 | 97.9 Titers |
| Prevnar13 1d Group | 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 | OPSONO-6B 5 Mth post dose 3 | 251.3 Titers |
| Prevnar13 1d Group | 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 | OPSONO-4 5 Mth post dose 3 | 48.2 Titers |
| Prevnar13 1d Group | 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 | OPSONO-9V 8 Mth post dose 3 | 436.7 Titers |
| Prevnar13 1d Group | 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 | OPSONO-1 1 Mth post dose 3 | 62.7 Titers |
| Prevnar13 1d Group | 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 | OPSONO-1 5 Mth post dose 3 | 10.1 Titers |
| Prevnar13 1d Group | 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 | OPSONO-1 8 Mth post dose 3 | 8.4 Titers |
| Prevnar13 1d Group | 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 | OPSONO-4 1 Mth post dose 3 | 784.0 Titers |
| Prevnar13 1d Group | 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 | OPSONO-4 8 Mth post dose 3 | 34.3 Titers |
| Prevnar13 1d Group | 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 | OPSONO-5 1 Mth post dose 3 | 51.4 Titers |
| Prevnar13 1d Group | 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 | OPSONO-5 5 Mth post dose 3 | 13.1 Titers |
| Prevnar13 1d Group | 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 | OPSONO-5 8 Mth post dose 3 | 8.3 Titers |
| Prevnar13 1d Group | 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 | OPSONO-6B 1 Mth post dose 3 | 432.8 Titers |
| Prevnar13 1d Group | 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 | OPSONO-6B 8 Mth post dose 3 | 126.0 Titers |
| Prevnar13 1d Group | 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 | OPSONO-7F 1 Mth post dose 3 | 2993.3 Titers |
| Prevnar13 1d Group | 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 | OPSONO-7F 5 Mth post dose 3 | 1850.6 Titers |
| Prevnar13 1d Group | 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 | OPSONO-7F 8 Mth post dose 3 | 2313.0 Titers |
| Prevnar13 1d Group | 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 | OPSONO-9V 1 Mth post dose 3 | 1113.1 Titers |
| Prevnar13 1d Group | 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 | OPSONO-9V 5 Mth post dose 3 | 449.2 Titers |
| Prevnar13 1d Group | 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 | OPSONO-14 1 Mth post dose 3 | 1169.8 Titers |
| Prevnar13 1d Group | 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 | OPSONO-14 5 Mth post dose 3 | 181.3 Titers |
| Prevnar13 1d Group | 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 | OPSONO-14 8 Mth post dose 3 | 186.9 Titers |
| Prevnar13 1d Group | 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 | OPSONO-18C 1 Mth post dose 3 | 532.0 Titers |
| Prevnar13 1d Group | 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 | OPSONO-18C 5 Mth post dose 3 | 32.0 Titers |
| Prevnar13 1d Group | 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 | OPSONO-18C 8 Mth post dose 3 | 11.7 Titers |
| Prevnar13 1d Group | 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 | OPSONO-19F 1 Mth post dose 3 | 340.6 Titers |
| Prevnar13 1d Group | 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 | OPSONO-19F 5 Mth post dose 3 | 30.7 Titers |
| Prevnar13 1d Group | 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 | OPSONO-19F 8 Mth post dose 3 | 20.3 Titers |
| Prevnar13 1d Group | 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 | OPSONO-23F 1 Mth post dose 3 | 965.1 Titers |
| Prevnar13 1d Group | 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 | OPSONO-23F 5 Mth post dose 3 | 387.1 Titers |
| Prevnar13 1d Group | 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 | OPSONO-23F 8 Mth post dose 3 | 385.9 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-5 8 Mth post dose 3 | 11.2 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-7F 8 Mth post dose 3 | 2291.2 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-19F 8 Mth post dose 3 | 32.5 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-9V 1 Mth post dose 3 | 1044.6 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-4 8 Mth post dose 3 | 41.7 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-9V 5 Mth post dose 3 | 320.1 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-9V 8 Mth post dose 3 | 277.0 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-14 1 Mth post dose 3 | 1139.9 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-4 1 Mth post dose 3 | 715.6 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-14 5 Mth post dose 3 | 233.4 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-23F 1 Mth post dose 3 | 1030.2 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-14 8 Mth post dose 3 | 223.1 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-1 8 Mth post dose 3 | 9.3 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-18C 1 Mth post dose 3 | 623.6 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-1 5 Mth post dose 3 | 11.0 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-23F 8 Mth post dose 3 | 410.8 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-18C 8 Mth post dose 3 | 16.9 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-23F 5 Mth post dose 3 | 239.5 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-19F 1 Mth post dose 3 | 518.3 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-1 1 Mth post dose 3 | 109.9 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-6B 1 Mth post dose 3 | 814.6 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-4 5 Mth post dose 3 | 54.7 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-6B 5 Mth post dose 3 | 324.0 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-19F 5 Mth post dose 3 | 66.9 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-6B 8 Mth post dose 3 | 233.1 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-5 5 Mth post dose 3 | 16.2 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-7F 1 Mth post dose 3 | 3767.9 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-18C 5 Mth post dose 3 | 44.1 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-7F 5 Mth post dose 3 | 1710.3 Titers |
| Synflorix 3+0d Group | 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 | OPSONO-5 1 Mth post dose 3 | 76.7 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-4 5 Mth post dose 3 | 62.8 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-18C 5 Mth post dose 3 | 9.1 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-7F 8 Mth post dose 3 | 3054.1 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-4 8 Mth post dose 3 | 41.8 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-5 8 Mth post dose 3 | 10.8 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-5 1 Mth post dose 3 | 91.5 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-9V 1 Mth post dose 3 | 878.3 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-19F 5 Mth post dose 3 | 7.2 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-19F 8 Mth post dose 3 | 7.0 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-18C 8 Mth post dose 3 | 6.5 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-9V 5 Mth post dose 3 | 342.8 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-1 1 Mth post dose 3 | 161.4 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-9V 8 Mth post dose 3 | 308.6 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-4 1 Mth post dose 3 | 1022.7 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-6B 8 Mth post dose 3 | 73.7 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-6B 5 Mth post dose 3 | 90.9 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-14 1 Mth post dose 3 | 2504.7 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-5 5 Mth post dose 3 | 17.4 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-23F 8 Mth post dose 3 | 650.4 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-19F 1 Mth post dose 3 | 84.8 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-14 5 Mth post dose 3 | 499.3 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-1 8 Mth post dose 3 | 12.5 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-7F 5 Mth post dose 3 | 3652.1 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-23F 5 Mth post dose 3 | 638.6 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-14 8 Mth post dose 3 | 371.0 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-7F 1 Mth post dose 3 | 7241.0 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-23F 1 Mth post dose 3 | 2821.9 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-6B 1 Mth post dose 3 | 1317.6 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-18C 1 Mth post dose 3 | 277.7 Titers |
| Prevnar13 3+0d Group | 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 | OPSONO-1 5 Mth post dose 3 | 14.3 Titers |
Secondary
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects
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.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | OPSONO-3 | 10.1 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | OPSONO-6A | 212.7 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | OPSONO-19A | 461.7 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | OPSONO-3 | 152.5 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | OPSONO-6A | 8488.8 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects | OPSONO-19A | 970.3 Titers |
Secondary
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
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.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-3 1 Mth post dose 2 | 4.7 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-6A 3 Mth post dose 3 | 12.6 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-3 5 Mth post dose 2 | 5.9 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-3 3 Mth post dose 3 | 7.4 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-6A 1 Mth post dose 2 | 6.7 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-6A 5 Mth post dose 2 | 12.4 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-6A 1 Mth post dose 2 | 6.7 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-3 3 Mth post dose 3 | 6.8 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-6A 3 Mth post dose 3 | 10.0 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-3 1 Mth post dose 2 | 5.1 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-6A 5 Mth post dose 2 | 12.2 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | OPSONO-3 5 Mth post dose 2 | 5.9 Titers |
Secondary
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
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.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-6A 8 Mth post dose 3 | 14.8 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-3 8 Mth post dose 3 | 8.1 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-3 5 Mth post dose 3 | 7.1 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-3 1 Mth post dose 3 | 5.3 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-6A 5 Mth post dose 3 | 14.8 Titers |
| 10PP-HD 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-6A 1 Mth post dose 3 | 13.7 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-6A 8 Mth post dose 3 | 12.4 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-6A 5 Mth post dose 3 | 12.0 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-3 1 Mth post dose 3 | 4.5 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-3 5 Mth post dose 3 | 5.5 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-3 8 Mth post dose 3 | 8.3 Titers |
| Prevnar13 1d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-6A 1 Mth post dose 3 | 11.8 Titers |
| Synflorix 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-3 8 Mth post dose 3 | 7.8 Titers |
| Synflorix 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-6A 8 Mth post dose 3 | 18.5 Titers |
| Synflorix 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-6A 5 Mth post dose 3 | 20.2 Titers |
| Synflorix 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-3 5 Mth post dose 3 | 6.7 Titers |
| Synflorix 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-6A 1 Mth post dose 3 | 11.3 Titers |
| Synflorix 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-3 1 Mth post dose 3 | 4.8 Titers |
| Prevnar13 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-6A 1 Mth post dose 3 | 2770.0 Titers |
| Prevnar13 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-3 8 Mth post dose 3 | 12.3 Titers |
| Prevnar13 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-6A 8 Mth post dose 3 | 260.1 Titers |
| Prevnar13 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-3 5 Mth post dose 3 | 15.1 Titers |
| Prevnar13 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-3 1 Mth post dose 3 | 98.3 Titers |
| Prevnar13 3+0d Group | Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | OPSONO-6A 5 Mth post dose 3 | 602.0 Titers |
Secondary
Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.
Time frame: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10PP-HD 1d Group | Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 342.0 Titers |
| Prevnar13 1d Group | Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 239.0 Titers |
Secondary
Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.
Time frame: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10PP-HD 1d Group | Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 334.0 Titers |
| Prevnar13 1d Group | Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 264.7 Titers |
| Synflorix 3+0d Group | Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 379.9 Titers |
| Prevnar13 3+0d Group | Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 306.7 Titers |
Other Pre-specified
Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene - Cohort 2
Isolates from the Prev13\_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).
Time frame: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)
Population: The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10PP-HD 1d Group | Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene - Cohort 2 | Positive isolates | 342 Samples |
| 10PP-HD 1d Group | Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene - Cohort 2 | Protein sequenced | 321 Samples |
| 10PP-HD 1d Group | Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene - Cohort 2 | Protein variants | 84 Samples |
| 10PP-HD 1d Group | Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene - Cohort 2 | Samples with Variant 1 | 1 Samples |
Other Pre-specified
Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene - Cohort 2
Isolates from the Prev13\_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).
Time frame: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)
Population: The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10PP-HD 1d Group | Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene - Cohort 2 | Samples with Variant 1 | 216 Samples |
| 10PP-HD 1d Group | Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene - Cohort 2 | Positive isolates | 347 Samples |
| 10PP-HD 1d Group | Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene - Cohort 2 | Protein sequenced | 347 Samples |
| 10PP-HD 1d Group | Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene - Cohort 2 | Protein variants | 18 Samples |
Other Pre-specified
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Because of high variants heterogeneity in each group (no major variant), the impact of vaccination on variant prevalence was not analysed. PhtD sequences were detected in some samples but no consensus sequence could be obtained they were defined as mixed sequences (Mix). The samples without gene detected were considered as negative for PhtD (PhtD negative).
Time frame: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)
Population: The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 7 | 13 Samples |
| 10PP-HD 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 0 | 10 Samples |
| 10PP-HD 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 10 | 1 Samples |
| 10PP-HD 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 7 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 3 | 16 Samples |
| 10PP-HD 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 0 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 7 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 10 | 13 Samples |
| 10PP-HD 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 3 | 1 Samples |
| 10PP-HD 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 3 | 1 Samples |
| 10PP-HD 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 0 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 10 | 1 Samples |
| Prevnar13 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 0 | 2 Samples |
| Prevnar13 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 3 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 7 | 14 Samples |
| Prevnar13 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 0 | 1 Samples |
| Prevnar13 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 0 | 6 Samples |
| Prevnar13 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 10 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 7 | 2 Samples |
| Prevnar13 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 10 | 12 Samples |
| Prevnar13 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 3 | 16 Samples |
| Prevnar13 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 10 | 1 Samples |
| Prevnar13 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 7 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 3 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 10 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 0 | 9 Samples |
| Synflorix 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 0 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 0 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 3 | 18 Samples |
| Synflorix 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 3 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 3 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 7 | 17 Samples |
| Synflorix 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 7 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 7 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 10 | 13 Samples |
| Synflorix 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 10 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 10 | 15 Samples |
| Prevnar13 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 7 | 1 Samples |
| Prevnar13 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 0 | 1 Samples |
| Prevnar13 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 7 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 0 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 10 | 1 Samples |
| Prevnar13 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 3 | 3 Samples |
| Prevnar13 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 3 | 16 Samples |
| Prevnar13 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 3 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 0 | 9 Samples |
| Prevnar13 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 7 | 13 Samples |
| Prevnar13 3+0d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 10 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 7 | 12 Samples |
| Synflorix 2+1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 7 | 1 Samples |
| Synflorix 2+1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 3 | 16 Samples |
| Synflorix 2+1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 10 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 7 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 0 | 1 Samples |
| Synflorix 2+1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 10 | 11 Samples |
| Synflorix 2+1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 0 | 2 Samples |
| Synflorix 2+1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 10 | 3 Samples |
| Synflorix 2+1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | PhtD negative at Month 3 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variants number at Month 0 | 7 Samples |
| Synflorix 2+1d Group | Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mix number at Month 3 | 1 Samples |
Other Pre-specified
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Overall, 18 different Ply protein sequences were identified: 5 protein variants previously described (e.g. variants 1, 2, 7, 11 and 15), plus 13 new protein variants which are referred to as variants GSK21 to GSK33. The number of Amino Acids (AA) mutation versus vaccine sequence has been specified for each Ply variant. The samples without gene detected were considered as negative for Ply (Ply negative).
Time frame: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)
Population: The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 3 | 4 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 10 | 5 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 29 - AA = 1 at Month 7 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 3 | 11 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 22 - AA = 2 at Month 10 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 11 - AA = 2 at Month 3 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 0 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 7 - AA = 2 at Month 7 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 0 | 1 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 33 - AA = 3 at Month 0 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 23 - AA = 2 at Month 3 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 23 - AA = 2 at Month 7 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 7 | 2 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 25 - AA = 1 at Month 10 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 3 | 1 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 7 | 14 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 10 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 0 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 0 | 4 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 10 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 7 | 4 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 21 - AA = 2 at Month 7 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 28 - AA = 1 at Month 0 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 27 - AA = 2 at Month 7 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 0 | 5 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 7 - AA = 2 at Month 10 | 1 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 3 | 2 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 10 | 1 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 32 - AA = 7 at Month 10 | 1 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 7 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 7 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 30 - AA = 4 at Month 0 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 3 | 2 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 26 - AA = 4 at Month 10 | 0 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 10 | 12 Samples |
| 10PP-HD 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 31 - AA = 6 at Month 0 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 10 | 15 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 22 - AA = 2 at Month 10 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 10 | 2 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 0 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 7 - AA = 2 at Month 10 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 10 | 1 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 25 - AA = 1 at Month 10 | 1 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 10 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 3 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 3 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 31 - AA = 6 at Month 0 | 1 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 0 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 0 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 3 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 23 - AA = 2 at Month 3 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 11 - AA = 2 at Month 3 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 3 | 7 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 7 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 3 | 13 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 29 - AA = 1 at Month 7 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 30 - AA = 4 at Month 0 | 1 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 0 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 7 - AA = 2 at Month 7 | 1 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 23 - AA = 2 at Month 7 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 21 - AA = 2 at Month 7 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 7 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 7 | 15 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 10 | 1 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 7 | 4 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 28 - AA = 1 at Month 0 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 27 - AA = 2 at Month 7 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 33 - AA = 3 at Month 0 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 32 - AA = 7 at Month 10 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 7 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 26 - AA = 4 at Month 10 | 0 Samples |
| Prevnar13 1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 0 | 8 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 0 | 7 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 30 - AA = 4 at Month 0 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 3 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 3 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 7 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 29 - AA = 1 at Month 7 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 7 - AA = 2 at Month 7 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 7 | 10 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 7 | 6 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 7 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 27 - AA = 2 at Month 7 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 7 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 10 | 12 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 10 | 6 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 10 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 10 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 25 - AA = 1 at Month 10 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 7 - AA = 2 at Month 10 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 22 - AA = 2 at Month 10 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 26 - AA = 4 at Month 10 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 32 - AA = 7 at Month 10 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 10 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 21 - AA = 2 at Month 7 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 23 - AA = 2 at Month 7 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 31 - AA = 6 at Month 0 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 0 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 3 | 10 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 3 | 6 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 3 | 2 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 11 - AA = 2 at Month 3 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 23 - AA = 2 at Month 3 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 0 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 0 | 0 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 0 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 28 - AA = 1 at Month 0 | 1 Samples |
| Synflorix 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 33 - AA = 3 at Month 0 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 0 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 27 - AA = 2 at Month 7 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 0 | 2 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 32 - AA = 7 at Month 10 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 7 | 13 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 30 - AA = 4 at Month 0 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 10 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 21 - AA = 2 at Month 7 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 7 - AA = 2 at Month 7 | 1 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 26 - AA = 4 at Month 10 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 23 - AA = 2 at Month 7 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 31 - AA = 6 at Month 0 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 29 - AA = 1 at Month 7 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 0 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 28 - AA = 1 at Month 0 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 3 | 14 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 7 | 1 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 3 | 4 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 3 | 1 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 3 | 1 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 7 | 1 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 11 - AA = 2 at Month 3 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 33 - AA = 3 at Month 0 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 23 - AA = 2 at Month 3 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 7 | 4 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 3 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 0 | 4 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 10 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 10 | 2 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 25 - AA = 1 at Month 10 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 10 | 5 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 0 | 4 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 7 - AA = 2 at Month 10 | 1 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 10 | 12 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 22 - AA = 2 at Month 10 | 0 Samples |
| Prevnar13 3+0d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 7 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 10 | 1 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 26 - AA = 4 at Month 10 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 27 - AA = 2 at Month 7 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 3 | 8 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 0 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 10 | 1 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 32 - AA = 7 at Month 10 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 7 | 10 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 3 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 10 | 14 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 33 - AA = 3 at Month 0 | 1 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 10 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 3 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 30 - AA = 4 at Month 0 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 0 | 8 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 21 - AA = 2 at Month 7 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 7 - AA = 2 at Month 7 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 7 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 7 | 7 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 25 - AA = 1 at Month 10 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 23 - AA = 2 at Month 7 | 1 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 0 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 10 | 4 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 31 - AA = 6 at Month 0 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 29 - AA = 1 at Month 7 | 1 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 11 - AA = 2 at Month 3 | 1 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 2 - AA = 1 at Month 0 | 1 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 3 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Ply negative at Month 0 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 24 - AA = 1 at Month 7 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 22 - AA = 2 at Month 10 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 23 - AA = 2 at Month 3 | 2 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 1 - AA = 0 at Month 3 | 9 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 7 - AA = 2 at Month 10 | 0 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant 15 - AA = 1 at Month 7 | 1 Samples |
| Synflorix 2+1d Group | Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Variant GSK 28 - AA = 1 at Month 0 | 0 Samples |
Other Pre-specified
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.
Time frame: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)
Population: The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 0 | 96.3 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 0 | 95.2 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 3 | 96.6 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 3 | 96.4 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 7 | 97.6 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 7 | 96.7 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 10 | 97.2 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 10 | 95.5 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 3 | 97.7 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 7 | 95.6 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 0 | 96.7 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 3 | 97.4 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 0 | 97.0 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 10 | 97.3 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 7 | 96.2 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 10 | 97.6 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 10 | 96.8 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 10 | 94.1 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 3 | 96.2 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 7 | 95.7 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 3 | 96.6 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 0 | 96.7 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 0 | 95.8 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 7 | 97.4 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 0 | 96.3 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 3 | 96.3 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 3 | 94.6 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 7 | 97.6 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 7 | 96.7 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 10 | 95.4 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 0 | 96.7 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 10 | 96.9 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 3 | 93.1 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 10 | 94.9 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 3 | 95.7 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 10 | 97.6 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 0 | 95.7 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 7 | 94.7 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 0 | 96.3 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 7 | 95.7 Percentage of protein identity |
Other Pre-specified
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.
Time frame: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)
Population: The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 10 | 100 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 10 | 99.84 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 3 | 100 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 3 | 99.91 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 7 | 100 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 0 | 99.90 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 7 | 99.94 Percentage of protein identity |
| 10PP-HD 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 0 | 99.90 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 7 | 99.94 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 3 | 99.93 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 10 | 100 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 7 | 100 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 3 | 100 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 10 | 99.95 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 0 | 99.79 Percentage of protein identity |
| Prevnar13 1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 0 | 100 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 0 | 99.94 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 3 | 100 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 0 | 100 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 3 | 99.90 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 7 | 99.86 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 7 | 99.90 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 10 | 99.87 Percentage of protein identity |
| Synflorix 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 10 | 100 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 7 | 100 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 10 | 100 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 3 | 100 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 7 | 99.92 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 0 | 99.79 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 0 | 99.87 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 3 | 99.94 Percentage of protein identity |
| Prevnar13 3+0d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 10 | 99.91 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 10 | 99.94 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 0 | 100 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 0 | 99.92 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 3 | 99.79 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 3 | 99.85 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 7 | 99.90 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Mean at Month 7 | 99.88 Percentage of protein identity |
| Synflorix 2+1d Group | Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2 | Median at Month 10 | 100 Percentage of protein identity |