| Primary | Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine. | The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in. For reasons of safety analysis related to rectal temperature, subjects were pooled to form the Synflorix Pooled Group and Prevenar Group. | Posted | | Count of Participants | | Participants | | Within 4 day (Days 0-3) after each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | Synflorix Pooled Group | Synflorix 1 Group and Synflorix 2 Group pooled together | | OG001 | Prevenar Pooled Group | Prevenar 1 Group and Prevenar 2 Group pooled together |
| | | Title | Denominators | Categories |
|---|
| Fever > 39.0°C, post Dose 1 | - ParticipantsOG000598
- ParticipantsOG001199
| |
| | 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 |
|---|
| Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever >39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines. | | | | | Difference in percentage | 2.17 | | | 2-Sided | 95 | -1.51 | 4.88 | | | | | Non-Inferiority or Equivalence | Standardized asymptotic 95% confidence interval (CI) for the difference [Synflorix™ minus Prevenar™] in terms of percentages of subjects reporting rectal fever >39.0°C after Dose 1 was computed. |
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| Secondary | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity. | The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in. | Posted | | Count of Participants | | Participants | | Within 4 day (Days 0-3) after each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Related (REL) = Symptom assessed by the investigator as causally related to vaccination. | The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in. | Posted | | Count of Participants | | Participants | | Within 4-day (Days 0-3) after each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 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" is 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 subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within 31 days (Days 0-30) after each vaccination | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
|
| 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 subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Number of Subjects With Serious Adverse (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 subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
|
| Secondary | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | 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 immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
|
| Secondary | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Cut-off values assessed were greater than or equal to 0.2 microgram per milliliter (µg/mL) in the sera of subjects. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
|
| Secondary | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Cut-off values assessed were greater than or equal to 0.05 microgram per liter (µg/mL) in the sera of subjects. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
|
| Secondary | Opsonophagocytic Activity (OPA) Against Vaccine 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 immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
|
| Secondary | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | 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 immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Concentrations of Antibodies Against Cross-reactive Pneumococcal 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 immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) | Cut-off values assessed were greater than or equal to 0.05 microgram per milliliter (μg/mL) in the sera of subjects seronegative before vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | |
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| Secondary | Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal 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 immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 | 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 immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Concentrations of Antibodies Against Protein D (Anti-PD) | Seropositivity status, defined as Anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL) | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL) | Cut-off values assessed were greater than or equal to 100 ELISA units per milliliter (EL.U/mL) in the sera of subjects. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
|
| Secondary | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL) | Cut-off values assessed were greater than or equal to 0.15 microgram per milliliter (µg/ mL) in the sera of subjects. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | Cut-off values assessed were greater than or equal to 1.0 microgram per milliliter (µg/mL) in the sera of subjects. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| 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 immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | | | | ID | Title | Description |
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| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | Cut-off values assessed were greater than or equal to 0.1 International Units per milliliter (IU/mL) in the sera of subjects. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Tritanrixâ„¢-HepB/Hiberixâ„¢ + Polio Sabinâ„¢ or Poliorixâ„¢ | | | | ID | Title | Description |
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| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | |
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| Secondary | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Seroprotection status, defined as Anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | | | | ID | Title | Description |
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| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL) | Cut-off values assessed were greater than or equal to 10 milli-International Units per milliliter (mIU/mL) in the sera of subjects. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Tritanrixâ„¢-HepB/Hiberixâ„¢ + Polio Sabinâ„¢ or Poliorixâ„¢ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | |
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| Secondary | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | Seroprotection status, defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | | | | ID | Title | Description |
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| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Titers were expressed as geometric mean titres (GMTs). | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | | | | ID | Title | Description |
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| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Anti-polio Type 1, 2 and 3 (Anti-Polio 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 immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | | | | ID | Title | Description |
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| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity) | Cut-off values assessed were greater than or equal to 15 ELISA unit per milli-liter (EL.U/mL) in the sera of subjects seronegative before vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Tritanrixâ„¢-HepB/Hiberixâ„¢ + Polio Sabinâ„¢ or Poliorixâ„¢ | | | | ID | Title | Description |
|---|
| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | |
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| Secondary | Anti-Bordetella Pertussis (Anti-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 immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | | | | ID | Title | Description |
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| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group | Subjects aged 6-12 weeks from the Philippines receiving the Prevenarâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ at 6, 10, 14 weeks of age. |
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| Secondary | Number of Subjects With Vaccine Response to Bordetella Pertussis | Vaccine response to B. pertussis;defined as appearance of antibodies in subjects initially seronegative (S-) (i.e., concentrations < 15 EL.U/mL) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e., with concentrations ≥ 15 EL.U/mL). | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | | | | ID | Title | Description |
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| OG000 | Synflorix 1 Group | Subjects aged 6-12 weeks from the Philippines receiving Synflorixâ„¢ vaccine, co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Polio Sabinâ„¢ vaccines at 6, 10, 14 weeks of age. | | OG001 | Synflorix 2 Group | Subjects aged 6-12 weeks from Poland receiving Synflorixâ„¢ vaccine co-administered with Tritanrixâ„¢-HepB/Hiberixâ„¢ and Poliorixâ„¢ vaccines at 2, 4, 6 months of age. | | OG002 | Prevenar 1 Group |
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