| Primary | Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off | Fever was measured as rectal temperature. The cut-off was 39.0 degree Celsius (°C). Assessment of occurrences of fever > 39.0 (°C) was performed after booster vaccination with Synflorix™ or Prevenar™ vaccines. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheets filled in. For the purpose of the analysis, subjects were pooled into two groups, according to the booster vaccine they have received (Synflorix™ or Prevenar™). | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) period after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Synflorix Pooled Group | Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorixâ„¢ vaccine, either co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines in the Philippines or co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines in Poland, at 12-18 months of age. | | OG001 | Prevenar Pooled Group | Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenarâ„¢ vaccine, either co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines in the Philippines or co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines in Poland, at 12-18 months of age. |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Philips' statistical test | | | | Difference in percentage | 0.89 | | | 2-Sided | 95 | -4.82 | 5.59 | | | | | Non-Inferiority | Non-inferiority was demonstrated if the difference in terms of incidence of post-immunization febrile reactions (rectal temperature > 39.0°C) in Synflorix™ vaccine minus Prevenar™ did not exceed the pre-defined clinically acceptable threshold of 5% + half the incidence in Prevenar. | |
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed included pain, redness and swelling. "Any" was defined as incidence of the specified symptom regardless of intensity. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (>) 30 millimeters (mm). | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheet filled-in. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) period after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature greater than or equal to (≥) 38.0°C), irritability, and loss of appetite."Any" was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) >40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheet filled-in. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) period after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. |
|
| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | An 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. "Any" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | Within the 31-day (Days 0-30) period after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | |
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | Throughout the active phase of the study (Month 0 to Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 12-18 months of age. |
|
| Secondary | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off | The cut-off was 0.20 microgram per milliliter (μg/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations | Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Antibody Concentrations to Protein D (Anti-PD) | Seropositivity status, defined as anti-PD antibody concentrations ≥100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Seropositivity status, defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off | The cut-off of the assay was 0.05 μg/mL. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | The cut-off for the assay was 8. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | The cut-of for the assay was 0.05 μg/mL. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off | The cut-off for the assay was 8. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | |
|
| Secondary | Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off | The cut-off for the assay was 100 ELISA units per milliliter (EL.U/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | |
|
| Secondary | Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Seroprotection status, defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international units per milliliter (IU/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations | Seroprotection status, defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorixâ„¢ Group |
|
| Secondary | Anti-Bordetella Pertussis (BPT) Antibody Concentrations | Seropositivity status, defined as anti-BPT antibody concentrations ≥ 15 EL.U/mL. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | |
|
| Secondary | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | Seroprotection status, defined as anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Anti-polio Type 1, 2 and 3 Antibody Titers | Seroprotection status, defined as anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers ≥ 8. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorixâ„¢ Group |
|
| Secondary | Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off | The cut-off for the assay was 15 EL.U/mL. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | |
|
| Secondary | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off | The cut-off for the assay was 0.1 milli-international units per milliliter (mIU/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
|
| Secondary | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off | The cut-off for the assay was 0.15 μg/mL. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | |
|
| Secondary | Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off | The cut-off for the assay was 1.0 μg/mL. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling). | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | |
|
| Secondary | Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off | The cut-off for the assay was 10 mIU/mL. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | |
|
| Secondary | Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off | The cut-off for the assay was 8. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Count of Participants | | Participants | | Prior to (Month 0) and one month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 | Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | |
|
| Secondary | Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT) | Vaccine response for anti-BPT, defined as the appearance of antibodies in subjects seronegative at pre-vaccination, or at least 2-fold increase of pre-vaccination antibody concentrations in those who were initially seropositive at pre-vaccination. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Count of Participants | | Participants | | One month after booster vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 12-18 months of age. | | OG001 | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/ Hiberixâ„¢ and Polio Sabinâ„¢ at 12-18 months of age. | | OG002 |
|