| Primary | Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off | The cut-off for core fever was 38.0 degrees Celsius (ºC). | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | Within 4 days (Day 0-3) after primary vaccine dose. | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | | OG002 | Synflorix PRE Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment. | | OG003 | Synflorix POST Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment. | | OG004 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. |
| | Units | Counts |
|---|
| Participants | - OG000178
- OG00127
- OG002172
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00064
- OG00114
- OG002100
- OG003
|
|
| | 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 |
|---|
| | | | | | Difference in percentages | 22.18 | | | 2-Sided | 95 | 11.78 | 32.11 | | | | | Superiority | Superiority criteria: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) for the difference between groups (Synflorix PRE Group minus Synflorix I Group) was above 0%. | |
|
| Secondary | Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | The cut-off value for core fever (rectal temperature) was 39.0ºC. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | Within 4 days (Day 0-3) after primary vaccination dose | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | | OG002 | Synflorix PRE Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment. |
|
| Secondary | Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling > 30 millimeters (mm) from injection site. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-primary vaccination period | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synflorixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | | OG002 |
|
| Secondary | Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were drowsiness, fever (rectal temperature ≥ 38.5°C), irritability and loss of appetite. Any was defined as any occurrence of the specified symptom regardless of intensity and relation to vaccination. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Grade 3 fever was defined as rectal temperature >40.0°C. Grade 3 irritability was defined as crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Related was defined as solicited symptoms assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | During the 4-day (Day 0-3) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment |
|
| Secondary | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | The outcome measure was not reporting statistics for all the arms in the baseline period. Results were tabulated on baseline groups except for the Synforix PRE and Synforix POST groups, for which results were presented for the Pooled Synforix PRE and POST Group. An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | Within 31 days (Days 0-30) after primary vaccine dose. | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment |
|
| Secondary | Number of Subjects Reported 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 entire study period (Month 0-Month 12) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | | OG002 | Synflorix PRE Group | |
|
| Secondary | Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits. | Results were tabulated only on Mencevax + Infanrix Hexa Group, according to the outcome measure specification of the protocol. | 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 | | Up to 6 months after vaccination with Mencevaxâ„¢ | | | | ID | Title | Description |
|---|
| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. |
| |
| Secondary | Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off | Certain pneumococcal serotypes includes pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). The seroprotection cut-off for the assay was ≥ 0.2 microgram per milliliter (μg/mL). | The analysis were performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment |
|
| Secondary | Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off. | Certain pneumococcal serotypes included pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). Seropositivity cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL). | The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment |
|
| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. | The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment |
|
| Secondary | Concentrations of Antibodies Against Protein D (Anti-PD) | The seropositivity cut-off for the assay was ≥ 100 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per milliliter (EL.U/mL). | The analyses were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | | OG002 |
|
| Secondary | Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) | Anti-6A and 19A antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). | The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 97.5% Confidence Interval | μg/mL | | Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | | OG002 |
|
| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. | The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titers | | Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment |
|
| Secondary | Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values | The cut-off values assessed were 1:8 and 1:128 for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). | The analysis was performed on the ATP cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | Prior to vaccination (PRE), 1 month (M1) and 12 months (M12) post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. |
| |
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group | Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). | The analysis was performed on the ATP cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination. | | | | ID | Title | Description |
|---|
| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. |
| |
| Secondary | Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values | Anti-PS assessed were anti-PS meningitidis serogroup A (anti-PSA), C (anti-PSC), W (anti-PSW-135) and Y (anti-PSY). The cut-offs for anti-PS concentrations were 0.3 μg/mL and 2.0 μg/mL, tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. |
| |
| Secondary | Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations | Anti-PS assessed were Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY. Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination. | | | | ID | Title | Description |
|---|
| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. |
| |
| Secondary | Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group | The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Prior to vaccination (Pre) | | | | ID | Title | Description |
|---|
| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. |
| |
| Secondary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group | The seroprotection cut-off for the assay was ≥ 10 milli international units per milliliter (mIU/mL). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). Dummy lower limit (LL) (0.0) and upper limit UL (99999.9) were entered when number of subjects analysed = 1. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | Prior to vaccination (Pre) | | | | ID | Title | Description |
|---|
| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. |
| |
| Secondary | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T). | The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | 1 month post-vaccination (M1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | | OG002 | Synflorix PRE Group |
|
| Secondary | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | The seropositivity cut-off for the assay was ≥ 5 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per millimiter (EL.U/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Number | 95% Confidence Interval | EL.U/mL | | 1 month post-vaccination (M1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | |
|
| Secondary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations | The seroprotection 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 subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | 1 month post-vaccination (M1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | | OG002 | Synflorix PRE Group |
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| Secondary | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations | The seroprotection cut-off for the assay was ≥ 0.15 μg/mL. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 1 month post-vaccination (M1) | | | | ID | Title | Description |
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| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of 10Pn vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | | OG002 | Synflorix PRE Group |
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| Secondary | Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers | The seroprotection cut-off for the assay was ≥ 8. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 month post-vaccination (M1) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | | OG002 | Synflorix PRE Group | |
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| Secondary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations | The seroprotection 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 subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | 12 month post-vaccination (M12) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | | OG002 | Synflorix PRE Group |
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| Secondary | Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers | The seroprotection cut-off for the assay was ≥ 8. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 12 month post-vaccination (M12) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix I Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa along with prophylactic antipyretic treatment. | | OG001 | Synflorix II Group | Subjects were vaccinated with 3 primary vaccination doses of Synforixâ„¢ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforixâ„¢ vaccine, co-administered with Infanrixâ„¢ hexa without prophylactic antipyretic treatment | | OG002 | Synflorix PRE Group | |
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| Secondary | Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes) | Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Number | | Swabs | | Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) | | | | ID | Title | Description |
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| OG000 | Pooled Synflorix Group | For carriage analyses the Synforix I, Synforix II, Synflorix PRE Group and Synflorix POST Group were pooled. | | OG001 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. |
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| Secondary | Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes) | Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Number | | Swabs | | Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) | | | | ID | Title | Description |
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| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. | | OG001 | Pooled Synflorix Group | For carriage analyses the Synforix I, Synforix II, Synflorix PRE Group and Synflorix POST Group were pooled. |
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| Secondary | Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) | Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Number | | Swabs | | Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) | | | | ID | Title | Description |
|---|
| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. | | OG001 | Pooled Synflorix Group | For carriage analyses the Synforix I, Synforix II, Synflorix PRE Group and Synflorix POST Group were pooled. |
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| Secondary | Number of Nasopharyngeal Swabs With H. Influenzae | Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Number | | Swabs | | Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) | | | | ID | Title | Description |
|---|
| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. | | OG001 | Pooled Synflorix Group | For carriage analyses the Synforix I, Synforix II, Synflorix PRE Group and Synflorix POST Group were pooled. |
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| Secondary | Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae | Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Number | | Swabs | | Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) | | | | ID | Title | Description |
|---|
| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. | | OG001 | Pooled Synflorix Group | For carriage analyses the Synforix I, Synforix II, Synflorix PRE Group and Synflorix POST Group were pooled. |
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| Secondary | Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs | Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) | | | | ID | Title | Description |
|---|
| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. | | OG001 | Pooled Synflorix Group | For carriage analyses the Synforix I, Synforix II, Synflorix PRE Group and Synflorix POST Group were pooled. |
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| Secondary | Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs. | Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) | | | | ID | Title | Description |
|---|
| OG000 | Mencevax + Infanrix Hexa Group | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevaxâ„¢ vaccine co-administered with Infanrixâ„¢ hexa vaccine. | | OG001 | Pooled Synflorix Group | For carriage analyses the Synforix I, Synforix II, Synflorix PRE Group and Synflorix POST Group were pooled. |
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