| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 13â„¢ at Day 0. Prevnar 13â„¢ was administered intramuscularly in the non-dominant deltoid. |
| | | Title | Denominators | Categories |
|---|
| Any Pain | | | | Grade 3 Pain | | |
| |
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 0 to Month 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Prevnar 13 1d Group | |
|
| 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 Synflorixâ„¢), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of the isolates. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 |
|
| 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 Synflorixâ„¢), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of isolates. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Prevnar 13 1d Group |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 0 to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Prevnar 13 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 13â„¢ at Day 0. Prevnar 13â„¢ was administered intramuscularly in the non-dominant deltoid. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | LU/mL | | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Prevnar 13 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 13â„¢ at Day 0. Prevnar 13â„¢ was administered intramuscularly in the non-dominant deltoid. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | LU/mL | | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Prevnar 13 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 13â„¢ at Day 0. Prevnar 13â„¢ was administered intramuscularly in the non-dominant deltoid. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Prevnar 13 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 13â„¢ at Day 0. Prevnar 13â„¢ was administered intramuscularly in the non-dominant deltoid. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Prevnar 13 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 13â„¢ at Day 0. Prevnar 13â„¢ was administered intramuscularly in the non-dominant deltoid. |
|
| 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. | 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. | Posted | | | | | | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 13â„¢ at Day 0. Prevnar 13â„¢ was administered intramuscularly in the non-dominant deltoid. |
| |
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Prevnar 13 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 13â„¢ at Day 0. Prevnar 13â„¢ was administered intramuscularly in the non-dominant deltoid. |
| |
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Prevnar 13 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 13â„¢ at Day 0. Prevnar 13â„¢ was administered intramuscularly in the non-dominant deltoid. |
| |
| 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. | 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. | Posted | | | | | | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 13â„¢ at Day 0. Prevnar 13â„¢ was administered intramuscularly in the non-dominant deltoid. |
| |
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Prevnar 13 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 13â„¢ at Day 0. Prevnar 13â„¢ was administered intramuscularly in the non-dominant deltoid. |
| |
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | 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™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | 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™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | 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™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | 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™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | 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™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | | | | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorixâ„¢ or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group |
|
| 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. | 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. | Posted | | | | | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 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™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 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™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally | |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 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™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | | | | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorixâ„¢ or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group |
|
| 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. | 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. | Posted | | | | | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | | | | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorixâ„¢ or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 |
|
| 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. | 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. | Posted | | | | | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™ | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group | |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™ | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™ | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group | |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™ | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorixâ„¢ or Prevnar 13â„¢), across doses | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorixâ„¢), across doses | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 31-day (Days 0-30) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorixâ„¢ or Prevnar 13â„¢), across doses | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 31-day (Days 0-30) periods post vaccination with the first 2 doses of pneumococcal vaccine (10PP vaccine or Synflorixâ„¢), across doses | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 31-day (Days 0-30) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 0 to Month 10 | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 0 to Month 10 | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorixâ„¢ or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group | |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorixâ„¢ or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorixâ„¢ or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorixâ„¢ or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | Synflorix 2+1d Group |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorixâ„¢ or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorixâ„¢ or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorixâ„¢ or Prevnar 13â„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 10PP-HD 3+0d Group |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | Synflorix 2+1d Group |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorixâ„¢) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ 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-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ at approximately 9 months of age.. The 2nd doses of Tritanrixâ„¢-Hep B/Hib and Polio Sabinâ„¢ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | | OG001 |
|
| 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). | 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. | Posted | | Number | | Samples | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Total "All 5" Group | A subset of samples selected for ply and phtD gene sequencing of S. pneumoniae isolates, isolated from nasopharyngeal samples across all time points and across study groups of Cohort 2 (Prev13_3 group was excluded). |
| |
| 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). | 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. | Posted | | Number | | Samples | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Total "All 5" Group | A subset of samples selected for ply and phtD gene sequencing of S. pneumoniae isolates, isolated from nasopharyngeal samples across all time points and across study groups of Cohort 2 (Prev13_3 group was excluded). |
| |
| 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). | 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. | Posted | | Number | | Samples | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Number | | Percentage of protein identity | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | |
|
| 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). | 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. | Posted | | Number | | Samples | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. |
|
| 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. | 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. | Posted | | Number | | Percentage of protein identity | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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 Tritanrixâ„¢-HepB/Hib and Polio Sabinâ„¢ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vacâ„¢, Stamarilâ„¢ and Polio Sabinâ„¢ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrixâ„¢-HepB/Hib, M-Vacâ„¢ and Stamarilâ„¢ were administered intramuscularly into the left thigh; Polio Sabinâ„¢ was administered orally. | |
|