Infections, Streptococcal
Conditions
Brief summary
The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two years of life will also be assessed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALGSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)
Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination
BIOLOGICALInfanrix™ hexa.
Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
BIOLOGICALPediacel™
Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
BIOLOGICALPrevenar™
Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardian(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. * A male or female between, and including, 6-12 weeks (42-90 days) of age at the time of the first vaccination. * Written informed consent obtained from both parents or from the guardian(s) of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Born after a gestation period of at least 36 weeks.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Concurrently participating in another clinical study, at any time during the entire study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from one month (30 days) before and up to one month (30 days) after each dose of study vaccine. * Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae. * Children for whom hepatitis B vaccination is required according to the local recommendations * History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Concentrations Against 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) - Primary Vaccination | At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine | Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL. |
| Antibody Concentration Against Protein D (PD) - Primary Vaccination | At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine | Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | At Month 3, one month after the administration of the third vaccine dose | Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8. |
| Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination. | At Month 3, one month after the administration of the third vaccine dose | Antibody concentrations against the cross- reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL. |
| Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination | At Month 3, one month after the administration of the third vaccine dose | Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations (Anti-6A and -19A) were measured by 22F-inhibition ELISA; presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination. | At Month 3, one month after the administration of the third vaccine dose | Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 8. |
| Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination | At Month 3, one month after the administration of the third vaccine dose | Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL. |
| Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination | At Month 3, one month after the administration of the third vaccine dose | Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL. |
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination. | At Month 3, one month after the administration of the third vaccine dose | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values \> 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration \> 100 mIU/mL or CLIA concentration \> 10 mIU/mL. |
| Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination. | At Month 3, one month after the administration of the third vaccine dose | Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8. |
| Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Prior to (Month 9) and one month after the administration of the booster dose (Month 10) | Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL. |
| Antibody Concentrations Against 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) - Booster Vaccination | Prior (Month 9) to and one month after the administration of the booster dose (Month 10) | Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL. |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Prior (Month 9) to and one month after the administration of the booster dose(Month 10) | Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8. |
| Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Prior (Month 9) to and one month after the administration of the booster dose(Month 10) | Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL. |
| Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Prior (Month 9) to and one month after the administration of the booster dose (Month 10) | Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL. |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Prior to (Month 9) and one month after the administration of the booster dose (Month 10) | Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8. |
| Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination. | Prior (Month 9) to and one month after (Month 10) the administration of the booster dose | Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. |
| Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Prior to (Month 9) and one month after (Month 10) the administration of the booster dose | Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL. |
| Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination | Prior to (Month 9) and one month after (Month 10) the administration of the booster dose | Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL. |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Prior (Month 9) to and one month after (Month 10) the administration of the booster dose | Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL. |
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination. | Prior (Month 9) to and one month after (Month 10) the administration of the booster dose | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values \> 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration \> 100 mIU/mL or CLIA concentration \> 10 mIU/mL. |
| Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Prior (Month 9) to and one month after (Month 10) the administration of the booster dose | Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8. |
| Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | One month after (Month 10) the administration of the booster dose | A booster responder to PT/FHA/PRN was defined as a subject with antibodies concentration ≥ 5 EL.U/mL against PT/FHA/PRN in subjects who were initially seronegative for anti-PT/FHA/PRN antibodies (i.e., subjects with anti-PT/FHA/PRN antibody concentrations \< 5 EL.U/mL), or antibody concentration ≥ 2 fold the pre-vaccination antibody concentration in subjects who were initially seropositive (i.e., subjects with anti-PT/FHA/PRN antibody concentrations ≥ 5 EL.U/mL). |
| Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL. |
| Antibody Concentrations Against 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) - 12 Months After Booster Dose. | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL. |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8. |
| Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL. |
| Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose. | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL. |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose. | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8. |
| Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose. | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. |
| Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21) | Positive cultures of H. influenzae\* (HI) and S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), M9 (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). \*Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay. |
| Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21) | Positive cultures of S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). |
| Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21) | Acquisition of new H. influenzae\* (HI) and S. pneumoniae (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). \*Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay. |
| Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21) | Acquisition of new S. pneumonia (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). |
| Number of Subjects With Solicited Local Symptoms - Primary Vaccination | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses | 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 spreading beyond (\>) 30 millimeters from injection site. |
| Number of Subjects With Solicited General Symptoms - Primary Vaccination | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses | Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 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. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination. | Within the 31-day (Days 0-30) post-primary vaccination | 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. |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination | At Month 3, one month after the administration of the third vaccine dose | Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL. |
| Number of Subjects With Solicited Local Symptoms -Booster Vaccination | During the 4-day (Days 0-3) post-vaccination period following booster dose | 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 from injection site. |
| Number of Subjects With Solicited General Symptoms - Booster Vaccination. | During the 4-day (Days 0-3) post-vaccination period following booster dose | Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 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. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination. | Within the 31-day (Days 0-30) after booster vaccination | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the entire study period (up to Month 21) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
| Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | At Month 3, one month after the administration of the third vaccine dose | Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL. |
Countries
Netherlands
Participant flow
Recruitment details
The study included a Primary (PRI) Phase, up to Month 3, followed by a Booster (BST) Phase, up to Month 9.
Pre-assignment details
At screening the following was performed: informed consent was obtained and signed from subjects' parents/guardians, check for inclusion/exclusion criteria and contraindications/precautions was performed as regards to vaccination, and medical history of subjects was collected. Subjects' pre-vaccination body temperature was evaluated.
Participants by arm
| Arm | Count |
|---|---|
| Synflorix + Infanrix Hexa Group Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | 260 |
| Synflorix + Pediacel Group Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. | 260 |
| Prevenar + Pediacel Group Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid. | 260 |
| Total | 780 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Booster Phase | Adverse event, non-fatal | 0 | 1 | 0 |
| Booster Phase | Other | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Synflorix + Infanrix Hexa Group | Synflorix + Pediacel Group | Prevenar + Pediacel Group | Total |
|---|---|---|---|---|
| Age, Continuous | 7.4 Weeks STANDARD_DEVIATION 1.2 | 7.6 Weeks STANDARD_DEVIATION 1.29 | 7.6 Weeks STANDARD_DEVIATION 1.26 | 7.53 Weeks STANDARD_DEVIATION 1.25 |
| Race/Ethnicity, Customized Geographic ancestry African heritage/African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Central/South Asian heritage | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Unspecified | 2 Participants | 3 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Arabic/North African heritage | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian/European heritage | 258 Participants | 255 Participants | 256 Participants | 769 Participants |
| Sex: Female, Male Female | 118 Participants | 130 Participants | 136 Participants | 384 Participants |
| Sex: Female, Male Male | 142 Participants | 130 Participants | 124 Participants | 396 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 260 | 0 / 260 | 0 / 260 |
| other Total, other adverse events | 260 / 260 | 260 / 260 | 260 / 260 |
| serious Total, serious adverse events | 35 / 260 | 26 / 260 | 35 / 260 |
Outcome results
Primary
Antibody Concentration Against Protein D (PD) - Primary Vaccination
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
Time frame: At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix + Infanrix Hexa Group | Antibody Concentration Against Protein D (PD) - Primary Vaccination | 1580 EL.U/mL |
| Synflorix + Pediacel Group | Antibody Concentration Against Protein D (PD) - Primary Vaccination | 1743 EL.U/mL |
| Prevenar + Pediacel Group | Antibody Concentration Against Protein D (PD) - Primary Vaccination | 69.7 EL.U/mL |
Comparison: The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns protein D.95% CI: [0.77, 1.06]ANOVA
Primary
Antibody Concentrations Against 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) - Primary Vaccination
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.
Time frame: At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-1 | 1.17 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-4 | 1.61 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-5 | 2.11 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-6B | 0.33 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-7F | 1.7 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-9V | 1.4 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-14 | 3.38 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-18C | 1.73 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-19F | 2.07 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-23F | 0.5 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-19F | 1.96 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-1 | 1.31 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-9V | 1.47 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-7F | 1.77 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-4 | 1.59 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-23F | 0.54 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-18C | 1.07 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-5 | 2.16 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-14 | 3.33 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-6B | 0.35 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-18C | 2.1 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-6B | 0.41 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-7F | 0.04 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-9V | 2.14 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-19F | 3.04 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-14 | 3.64 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-1 | 0.03 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-23F | 1.24 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-4 | 2.44 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Primary Vaccination | Anti-5 | 0.03 μg/mL |
Comparison: The 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 1.95% CI: [0.74, 1.07]ANOVA
Comparison: The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 4.95% CI: [0.84, 1.23]ANOVA
Comparison: The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 5.95% CI: [0.83, 1.15]ANOVA
Comparison: The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 6B.95% CI: [0.69, 1.26]ANOVA
Comparison: The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel Group groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 7F.95% CI: [0.82, 1.13]ANOVA
Comparison: The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 9V.95% CI: [0.78, 1.16]ANOVA
Comparison: The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 14.95% CI: [0.85, 1.21]ANOVA
Comparison: The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over ), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 18C.95% CI: [1.28, 2.03]ANOVA
Comparison: The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 19F.95% CI: [0.82, 1.36]ANOVA
Comparison: The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa Group and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 23F.95% CI: [0.7, 1.23]ANOVA
Secondary
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose.
Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.
Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose. | Anti-6A, Month 21 | 0.14 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose. | Anti-19A, Month 21 | 0.43 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose. | Anti-6A, Month 21 | 0.15 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose. | Anti-19A, Month 21 | 0.29 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose. | Anti-6A, Month 21 | 0.22 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose. | Anti-19A, Month 21 | 0.21 μg/mL |
Secondary
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination
Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.
Time frame: Prior (Month 9) to and one month after the administration of the booster dose (Month 10)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-6A, Month 9 | 0.1 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-19A, Month 9 | 0.12 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-6A, Month 10 | 0.45 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-19A, Month 10 | 0.5 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-19A, Month 10 | 0.52 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-6A, Month 9 | 0.11 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-6A, Month 10 | 0.49 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-19A, Month 9 | 0.12 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-19A, Month 10 | 0.21 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-19A, Month 9 | 0.06 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-6A, Month 10 | 0.71 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-6A, Month 9 | 0.06 μg/mL |
Secondary
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination
Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations (Anti-6A and -19A) were measured by 22F-inhibition ELISA; presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.
Time frame: At Month 3, one month after the administration of the third vaccine dose
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination | Anti-6A | 0.1 µg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination | Anti-19A | 0.1 µg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination | Anti-6A | 0.1 µg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination | Anti-19A | 0.09 µg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination | Anti-6A | 0.08 µg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination | Anti-19A | 0.08 µg/mL |
Secondary
Antibody Concentrations Against 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) - 12 Months After Booster Dose.
Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.
Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-1, Month 21 | 0.3 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-4, Month 21 | 0.25 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-5, Month 21 | 0.45 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-6B, Month 21 | 0.3 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-7F, Month 21 | 0.72 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-9V, Month 21 | 0.74 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-14, Month 21 | 0.73 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-18C, Month 21 | 1.03 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-19F, Month 21 | 1.48 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-23F, Month 21 | 0.51 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-19F, Month 21 | 1.46 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-1, Month 21 | 0.32 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-9V, Month 21 | 0.78 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-7F, Month 21 | 0.73 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-4, Month 21 | 0.29 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-23F, Month 21 | 0.52 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-18C, Month 21 | 0.64 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-5, Month 21 | 0.47 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-14, Month 21 | 0.85 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-6B, Month 21 | 0.32 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-18C, Month 21 | 1.66 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-6B, Month 21 | 0.46 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-7F, Month 21 | 0.04 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-9V, Month 21 | 0.81 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-19F, Month 21 | 1.76 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-14, Month 21 | 1.28 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-1, Month 21 | 0.04 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-23F, Month 21 | 1.01 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-4, Month 21 | 0.36 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - 12 Months After Booster Dose. | Anti-5, Month 21 | 0.05 μg/mL |
Secondary
Antibody Concentrations Against 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) - Booster Vaccination
Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.
Time frame: Prior (Month 9) to and one month after the administration of the booster dose (Month 10)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-7F, Month 10 | 3.79 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-18C, Month 9 | 0.58 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-1, Month 9 | 0.2 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-6B, Month 10 | 1.45 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-19F, Month 9 | 0.79 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-6B, Month 9 | 0.3 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-5, Month 10 | 3.27 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-23F, Month 9 | 0.33 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-23F, Month 10 | 2.32 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-4, Month 10 | 3.04 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-1, Month 10 | 2.16 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-18C, Month 10 | 6.36 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-7F, Month 9 | 0.6 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-19F, Month 10 | 5.45 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-14, Month 10 | 4.59 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-9V, Month 9 | 0.68 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-5, Month 9 | 0.41 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-9V, Month 10 | 3.96 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-14, Month 9 | 1.06 μg/mL |
| Synflorix + Infanrix Hexa Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-4, Month 9 | 0.39 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-18C, Month 10 | 4.63 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-1, Month 9 | 0.22 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-4, Month 9 | 0.43 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-5, Month 9 | 0.42 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-6B, Month 9 | 0.32 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-7F, Month 9 | 0.62 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-9V, Month 9 | 0.76 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-14, Month 9 | 1.14 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-18C, Month 9 | 0.43 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-19F, Month 9 | 0.9 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-23F, Month 9 | 0.38 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-1, Month 10 | 2.5 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-4, Month 10 | 3.29 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-5, Month 10 | 3.27 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-6B, Month 10 | 1.41 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-7F, Month 10 | 4.06 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-9V, Month 10 | 4.23 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-14, Month 10 | 4.95 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-19F, Month 10 | 5.8 μg/mL |
| Synflorix + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-23F, Month 10 | 2.6 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-4, Month 9 | 0.38 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-6B, Month 10 | 2.52 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-14, Month 9 | 1.55 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-23F, Month 10 | 5.32 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-7F, Month 10 | 0.03 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-9V, Month 9 | 0.55 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-19F, Month 10 | 2.4 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-9V, Month 10 | 6.05 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-7F, Month 9 | 0.03 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-1, Month 9 | 0.03 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-14, Month 10 | 7.31 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-6B, Month 9 | 0.13 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-1, Month 10 | 0.03 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-23F, Month 9 | 0.26 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-5, Month 9 | 0.03 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-4, Month 10 | 4.01 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-19F, Month 9 | 0.31 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-18C, Month 10 | 5.08 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-5, Month 10 | 0.04 μg/mL |
| Prevenar + Pediacel Group | Antibody Concentrations Against 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) - Booster Vaccination | Anti-18C, Month 9 | 0.4 μg/mL |
Secondary
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values \> 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration \> 100 mIU/mL or CLIA concentration \> 10 mIU/mL.
Time frame: Prior (Month 9) to and one month after (Month 10) the administration of the booster dose
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination. | Anti-HBs, Month 9 | 142.1 mIU/mL |
| Synflorix + Infanrix Hexa Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination. | Anti-HBs, Month 10 | 1981 mIU/mL |
| Synflorix + Pediacel Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination. | Anti-HBs, Month 9 | 9.9 mIU/mL |
| Synflorix + Pediacel Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination. | Anti-HBs, Month 10 | 8.6 mIU/mL |
| Prevenar + Pediacel Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination. | Anti-HBs, Month 9 | 9.9 mIU/mL |
| Prevenar + Pediacel Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination. | Anti-HBs, Month 10 | 8.5 mIU/mL |
Secondary
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values \> 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration \> 100 mIU/mL or CLIA concentration \> 10 mIU/mL.
Time frame: At Month 3, one month after the administration of the third vaccine dose
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix + Infanrix Hexa Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination. | 356.9 mIU/mL |
| Synflorix + Pediacel Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination. | 14 mIU/mL |
| Prevenar + Pediacel Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination. | 11.5 mIU/mL |
Secondary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.
Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.
Time frame: Prior (Month 9) to and one month after (Month 10) the administration of the booster dose
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PT, Month 9 | 7.4 EL.U/mL |
| Synflorix + Infanrix Hexa Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-FHA, Month 9 | 34 EL.U/mL |
| Synflorix + Infanrix Hexa Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PRN, Month 9 | 14.1 EL.U/mL |
| Synflorix + Infanrix Hexa Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PT, Month 10 | 53.5 EL.U/mL |
| Synflorix + Infanrix Hexa Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-FHA, Month 10 | 343.5 EL.U/mL |
| Synflorix + Infanrix Hexa Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PRN, Month 10 | 281.7 EL.U/mL |
| Synflorix + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PRN, Month 10 | 97.8 EL.U/mL |
| Synflorix + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PT, Month 9 | 6 EL.U/mL |
| Synflorix + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PT, Month 10 | 47.4 EL.U/mL |
| Synflorix + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-FHA, Month 10 | 135.7 EL.U/mL |
| Synflorix + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-FHA, Month 9 | 35.3 EL.U/mL |
| Synflorix + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PRN, Month 9 | 6.8 EL.U/mL |
| Prevenar + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-FHA, Month 9 | 34.7 EL.U/mL |
| Prevenar + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PRN, Month 9 | 8.6 EL.U/mL |
| Prevenar + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PRN, Month 10 | 106.4 EL.U/mL |
| Prevenar + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PT, Month 10 | 54.8 EL.U/mL |
| Prevenar + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PT, Month 9 | 6.6 EL.U/mL |
| Prevenar + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-FHA, Month 10 | 140 EL.U/mL |
Secondary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination
Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.
Time frame: At Month 3, one month after the administration of the third vaccine dose
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination | Anti-FHA | 145.6 EL.U/mL |
| Synflorix + Infanrix Hexa Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination | Anti-PT | 42.7 EL.U/mL |
| Synflorix + Infanrix Hexa Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination | Anti-PRN | 97.6 EL.U/mL |
| Synflorix + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination | Anti-FHA | 100.8 EL.U/mL |
| Synflorix + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination | Anti-PT | 36.4 EL.U/mL |
| Synflorix + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination | Anti-PRN | 40.1 EL.U/mL |
| Prevenar + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination | Anti-PT | 40.1 EL.U/mL |
| Prevenar + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination | Anti-PRN | 45.1 EL.U/mL |
| Prevenar + Pediacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination | Anti-FHA | 100.5 EL.U/mL |
Secondary
Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.
Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.
Time frame: Prior (Month 9) to and one month after (Month 10) the administration of the booster dose
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 1, Month 9 | 8.3 Titers |
| Synflorix + Infanrix Hexa Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 2, Month 9 | 13.4 Titers |
| Synflorix + Infanrix Hexa Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 3, Month 9 | 11.3 Titers |
| Synflorix + Infanrix Hexa Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 1, Month 10 | 370.7 Titers |
| Synflorix + Infanrix Hexa Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 2, Month 10 | 710.8 Titers |
| Synflorix + Infanrix Hexa Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 3, Month 10 | 631.5 Titers |
| Synflorix + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 3, Month 10 | 311.9 Titers |
| Synflorix + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 1, Month 9 | 7.3 Titers |
| Synflorix + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 1, Month 10 | 177.5 Titers |
| Synflorix + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 2, Month 10 | 338.8 Titers |
| Synflorix + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 2, Month 9 | 10.6 Titers |
| Synflorix + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 3, Month 9 | 9 Titers |
| Prevenar + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 2, Month 9 | 10.4 Titers |
| Prevenar + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 3, Month 9 | 8.7 Titers |
| Prevenar + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 3, Month 10 | 348.3 Titers |
| Prevenar + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 1, Month 10 | 221.2 Titers |
| Prevenar + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 1, Month 9 | 7 Titers |
| Prevenar + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 2, Month 10 | 481.4 Titers |
Secondary
Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination.
Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.
Time frame: At Month 3, one month after the administration of the third vaccine dose
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination. | Anti-polio 2 | 37.1 Titers |
| Synflorix + Infanrix Hexa Group | Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination. | Anti-polio 1 | 27.2 Titers |
| Synflorix + Infanrix Hexa Group | Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination. | Anti-polio 3 | 47.3 Titers |
| Synflorix + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination. | Anti-polio 2 | 29 Titers |
| Synflorix + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination. | Anti-polio 1 | 16 Titers |
| Synflorix + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination. | Anti-polio 3 | 34.2 Titers |
| Prevenar + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination. | Anti-polio 1 | 18.1 Titers |
| Prevenar + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination. | Anti-polio 3 | 26.7 Titers |
| Prevenar + Pediacel Group | Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination. | Anti-polio 2 | 23.2 Titers |
Secondary
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination
Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.
Time frame: Prior to (Month 9) and one month after (Month 10) the administration of the booster dose
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination | Anti-PRP, Month 9 | 0.475 µg/mL |
| Synflorix + Infanrix Hexa Group | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination | Anti-PRP, Month 10 | 19.331 µg/mL |
| Synflorix + Pediacel Group | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination | Anti-PRP, Month 9 | 0.855 µg/mL |
| Synflorix + Pediacel Group | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination | Anti-PRP, Month 10 | 39.383 µg/mL |
| Prevenar + Pediacel Group | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination | Anti-PRP, Month 9 | 0.371 µg/mL |
| Prevenar + Pediacel Group | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination | Anti-PRP, Month 10 | 23.676 µg/mL |
Secondary
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination
Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.
Time frame: At Month 3, one month after the administration of the third vaccine dose
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix + Infanrix Hexa Group | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination | 2.139 µg/mL |
| Synflorix + Pediacel Group | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination | 4.796 µg/mL |
| Prevenar + Pediacel Group | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination | 2.219 µg/mL |
Secondary
Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination.
Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.
Time frame: Prior to (Month 9) and one month after (Month 10) the administration of the booster dose
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-diphteria, Month 9 | 0.235 IU/mL |
| Synflorix + Infanrix Hexa Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-tetanus, Month 9 | 0.728 IU/mL |
| Synflorix + Infanrix Hexa Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-diphteria, Month 10 | 4.061 IU/mL |
| Synflorix + Infanrix Hexa Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-tetanus, Month 10 | 8.628 IU/mL |
| Synflorix + Pediacel Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-tetanus, Month 10 | 5.989 IU/mL |
| Synflorix + Pediacel Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-diphteria, Month 9 | 0.232 IU/mL |
| Synflorix + Pediacel Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-diphteria, Month 10 | 3.226 IU/mL |
| Synflorix + Pediacel Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-tetanus, Month 9 | 0.536 IU/mL |
| Prevenar + Pediacel Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-tetanus, Month 10 | 3.248 IU/mL |
| Prevenar + Pediacel Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-tetanus, Month 9 | 0.232 IU/mL |
| Prevenar + Pediacel Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-diphteria, Month 10 | 4.882 IU/mL |
| Prevenar + Pediacel Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-diphteria, Month 9 | 0.266 IU/mL |
Secondary
Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination
Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.
Time frame: At Month 3, one month after the administration of the third vaccine dose
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination | Anti-diphteria | 1.475 IU/mL |
| Synflorix + Infanrix Hexa Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination | Anti-tetanus | 2.873 IU/mL |
| Synflorix + Pediacel Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination | Anti-diphteria | 1.078 IU/mL |
| Synflorix + Pediacel Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination | Anti-tetanus | 1.702 IU/mL |
| Prevenar + Pediacel Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination | Anti-diphteria | 1.077 IU/mL |
| Prevenar + Pediacel Group | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination | Anti-tetanus | 0.934 IU/mL |
Secondary
Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose.
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix + Infanrix Hexa Group | Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose. | 332 EL.U/mL |
| Synflorix + Pediacel Group | Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose. | 423 EL.U/mL |
| Prevenar + Pediacel Group | Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose. | 81.4 EL.U/mL |
Secondary
Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination.
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
Time frame: Prior (Month 9) to and one month after (Month 10) the administration of the booster dose
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination. | Anti-PD, Month 9 | 421 EL.U/mL |
| Synflorix + Infanrix Hexa Group | Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination. | Anti-PD, Month 10 | 1715 EL.U/mL |
| Synflorix + Pediacel Group | Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination. | Anti-PD, Month 9 | 520.5 EL.U/mL |
| Synflorix + Pediacel Group | Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination. | Anti-PD, Month 10 | 1936.8 EL.U/mL |
| Prevenar + Pediacel Group | Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination. | Anti-PD, Month 9 | 80.8 EL.U/mL |
| Prevenar + Pediacel Group | Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination. | Anti-PD, Month 10 | 84.1 EL.U/mL |
Secondary
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.
Acquisition of new H. influenzae\* (HI) and S. pneumoniae (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). \*Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.
Time frame: Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)
Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any SP, M9 | 103 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any SP, M12 | 86 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any SP, M16 | 128 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any SP, M21 | 132 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any HI, M9 | 88 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any HI, M12 | 47 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any HI, M16 | 71 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any HI, M21 | 73 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any SP, M16 | 105 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any HI, M16 | 55 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any SP, M21 | 113 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any HI, M9 | 84 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any HI, M12 | 48 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any SP, M9 | 114 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any SP, M12 | 95 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any HI, M21 | 75 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any SP, M16 | 125 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any SP, M12 | 90 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any SP, M9 | 107 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any SP, M21 | 110 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any HI, M16 | 64 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any HI, M12 | 58 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any HI, M9 | 83 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Any HI, M21 | 71 Participants |
Secondary
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
Acquisition of new S. pneumonia (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).
Time frame: Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)
Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, VS - M9 | 14 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, VS - M12 | 8 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, VS - M16 | 13 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, VS - M21 | 4 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, CRS - M9 | 13 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, CRS - M12 | 19 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, CRS - M16 | 27 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, CRS - M21 | 22 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, OS - M9 | 64 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, OS - M12 | 52 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, OS - M16 | 74 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, OS - M21 | 87 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, OS - M21 | 69 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, VS - M9 | 11 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, CRS - M16 | 25 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, OS - M9 | 55 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, VS - M12 | 9 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, CRS - M12 | 15 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, OS - M16 | 55 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, VS - M16 | 7 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, CRS - M21 | 8 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, CRS - M9 | 26 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, VS - M21 | 7 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, OS - M12 | 59 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, VS - M21 | 6 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, CRS - M9 | 20 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, OS - M12 | 52 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, CRS - M12 | 20 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, CRS - M16 | 24 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, CRS - M21 | 18 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, OS - M16 | 77 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, VS - M9 | 15 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, VS - M12 | 8 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, OS - M9 | 57 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, VS - M16 | 9 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | S. pneumoniae, OS - M21 | 69 Participants |
Secondary
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.
Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-6A, Month 21 | 54 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-19A, Month 21 | 120 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-6A, Month 21 | 57 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-19A, Month 21 | 97 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-6A, Month 21 | 92 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-19A, Month 21 | 80 Participants |
Secondary
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination.
Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.
Time frame: Prior (Month 9) to and one month after the administration of the booster dose(Month 10)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Anti-6A, Month 9 | 50 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Anti-19A, Month 9 | 61 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Anti-6A, Month 10 | 135 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Anti-19A, Month 10 | 130 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Anti-19A, Month 10 | 139 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Anti-6A, Month 9 | 56 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Anti-6A, Month 10 | 142 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Anti-19A, Month 9 | 63 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Anti-19A, Month 10 | 97 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Anti-19A, Month 9 | 29 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Anti-6A, Month 10 | 160 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Anti-6A, Month 9 | 28 Participants |
Secondary
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination.
Antibody concentrations against the cross- reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.
Time frame: At Month 3, one month after the administration of the third vaccine dose
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination. | Anti-6A | 58 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination. | Anti-19A | 56 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination. | Anti-6A | 51 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination. | Anti-19A | 50 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination. | Anti-6A | 41 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination. | Anti-19A | 40 Participants |
Secondary
Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.
Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-1, Month 21 | 106 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-4, Month 21 | 101 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-5, Month 21 | 129 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-6B, Month 21 | 94 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-7F, Month 21 | 157 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-9V, Month 21 | 155 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-14, Month 21 | 149 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-18C, Month 21 | 160 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-19F, Month 21 | 158 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-23F, Month 21 | 123 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-19F, Month 21 | 158 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-1, Month 21 | 108 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-9V, Month 21 | 157 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-7F, Month 21 | 157 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-4, Month 21 | 102 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-23F, Month 21 | 126 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-18C, Month 21 | 155 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-5, Month 21 | 129 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-14, Month 21 | 156 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-6B, Month 21 | 96 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-18C, Month 21 | 161 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-6B, Month 21 | 133 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-7F, Month 21 | 15 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-9V, Month 21 | 160 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-19F, Month 21 | 134 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-14, Month 21 | 173 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-1, Month 21 | 6 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-23F, Month 21 | 153 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-4, Month 21 | 130 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Anti-5, Month 21 | 10 Participants |
Secondary
Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination
Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.
Time frame: Prior to (Month 9) and one month after the administration of the booster dose (Month 10)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-7F, Month 10 | 189 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-18C, Month 9 | 152 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-1, Month 9 | 84 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-6B, Month 10 | 176 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-19F, Month 9 | 149 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-6B, Month 9 | 117 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-5, Month 10 | 185 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-23F, Month 9 | 123 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-23F, Month 10 | 179 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-4, Month 10 | 187 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-1, Month 10 | 187 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-18C, Month 10 | 188 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-7F, Month 9 | 165 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-19F, Month 10 | 180 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-14, Month 10 | 190 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-9V, Month 9 | 168 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-5, Month 9 | 142 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-9V, Month 10 | 188 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-14, Month 9 | 170 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-4, Month 9 | 136 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-18C, Month 10 | 196 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-1, Month 9 | 92 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-4, Month 9 | 147 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-5, Month 9 | 152 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-6B, Month 9 | 127 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-7F, Month 9 | 164 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-9V, Month 9 | 168 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-14, Month 9 | 172 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-18C, Month 9 | 143 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-19F, Month 9 | 157 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-23F, Month 9 | 140 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-1, Month 10 | 195 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-4, Month 10 | 194 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-5, Month 10 | 191 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-6B, Month 10 | 181 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-7F, Month 10 | 198 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-9V, Month 10 | 197 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-14, Month 10 | 197 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-19F, Month 10 | 191 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-23F, Month 10 | 190 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-4, Month 9 | 148 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-6B, Month 10 | 192 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-14, Month 9 | 190 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-23F, Month 10 | 194 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-7F, Month 10 | 8 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-9V, Month 9 | 176 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-19F, Month 10 | 196 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-9V, Month 10 | 202 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-7F, Month 9 | 5 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-1, Month 9 | 6 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-14, Month 10 | 198 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-6B, Month 9 | 62 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-1, Month 10 | 7 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-23F, Month 9 | 108 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-5, Month 9 | 3 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-4, Month 10 | 198 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-19F, Month 9 | 109 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-18C, Month 10 | 200 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-5, Month 10 | 4 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Booster Vaccination | Anti-18C, Month 9 | 151 Participants |
Secondary
Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination
Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.
Time frame: At Month 3, one month after the administration of the third vaccine dose
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-1 | 174 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-4 | 188 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-5 | 187 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-6B | 122 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-7F | 190 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-9V | 176 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-14 | 191 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-18C | 183 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-19F | 180 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-23F | 134 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-19F | 174 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-1 | 176 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-9V | 181 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-7F | 186 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-4 | 180 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-23F | 133 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-18C | 178 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-5 | 179 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-14 | 187 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-6B | 113 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-18C | 187 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-6B | 124 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-7F | 11 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-9V | 184 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-19F | 189 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-14 | 192 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-1 | 5 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-23F | 171 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-4 | 189 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Antibody Concentrations Against 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) ≥ 0.2 μg/mL - Primary Vaccination | Anti-5 | 0 Participants |
Secondary
Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.
A booster responder to PT/FHA/PRN was defined as a subject with antibodies concentration ≥ 5 EL.U/mL against PT/FHA/PRN in subjects who were initially seronegative for anti-PT/FHA/PRN antibodies (i.e., subjects with anti-PT/FHA/PRN antibody concentrations \< 5 EL.U/mL), or antibody concentration ≥ 2 fold the pre-vaccination antibody concentration in subjects who were initially seropositive (i.e., subjects with anti-PT/FHA/PRN antibody concentrations ≥ 5 EL.U/mL).
Time frame: One month after (Month 10) the administration of the booster dose
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-PT, S- seronegative | 40 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-PT, S+ seropositive | 95 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-FHA, S- seronegative | 4 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-FHA, S+ seropositive | 128 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-PRN, S- seronegative | 18 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-PRN, S+ seropositive | 122 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-PRN, S+ seropositive | 88 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-PT, S- seronegative | 47 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-FHA, S+ seropositive | 119 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-PRN, S- seronegative | 56 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-PT, S+ seropositive | 94 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-FHA, S- seronegative | 1 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-PT, S+ seropositive | 98 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-FHA, S- seronegative | 2 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-PRN, S+ seropositive | 101 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-FHA, S+ seropositive | 125 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-PT, S- seronegative | 48 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | Anti-PRN, S- seronegative | 51 Participants |
Secondary
Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.
Positive cultures of H. influenzae\* (HI) and S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), M9 (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). \*Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.
Time frame: One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)
Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 3 | 102 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 9 | 115 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 12 | 121 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 16 | 151 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 21 | 154 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 3 | 94 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 9 | 152 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 12 | 159 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 16 | 185 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 21 | 192 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 16 | 169 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 3 | 109 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 3 | 91 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 21 | 139 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 9 | 134 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 21 | 192 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 12 | 160 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 12 | 131 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 9 | 155 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 16 | 135 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 12 | 165 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 16 | 148 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 21 | 131 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 3 | 85 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 16 | 162 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 9 | 144 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 3 | 100 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any HI, Month 21 | 177 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 9 | 119 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Any SP, Month 12 | 126 Participants |
Secondary
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
Positive cultures of S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).
Time frame: One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)
Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M3 | 25 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M12 | 11 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M3 | 45 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M9 | 15 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M9 | 16 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M21 | 28 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M12 | 25 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M12 | 74 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M16 | 33 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M16 | 15 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M21 | 97 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M3 | 18 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M21 | 8 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M16 | 86 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M9 | 69 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M9 | 61 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M3 | 25 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M9 | 20 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M12 | 18 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M16 | 12 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M21 | 8 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M3 | 32 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M9 | 30 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M12 | 26 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M16 | 33 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M21 | 13 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M3 | 40 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M12 | 69 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M16 | 67 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M21 | 81 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M3 | 20 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M16 | 89 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M3 | 51 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M21 | 8 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M16 | 12 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M9 | 60 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M12 | 13 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M3 | 21 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M12 | 70 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M12 | 27 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, VS - M9 | 18 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M16 | 31 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M9 | 25 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, OS - M21 | 80 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | S. pneumoniae, CRS - M21 | 25 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: Throughout the entire study period (up to Month 21)
Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Serious Adverse Events (SAEs) | 35 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Serious Adverse Events (SAEs) | 26 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Serious Adverse Events (SAEs) | 35 Participants |
Secondary
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 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. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following booster dose
Population: The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Any Drowsiness | 131 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Grade 3 Drowsiness | 6 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Related Drowsiness | 126 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Any Temperature | 100 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Grade 3 Temperature | 1 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Related Temperature | 95 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Any Irritability | 167 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Grade 3 Irritability | 11 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Related Irritability | 161 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Any Loss of appetite | 93 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Grade 3 Loss of appetite | 5 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Related Loss of appetite | 89 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Related Loss of appetite | 72 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Any Drowsiness | 118 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Any Irritability | 161 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Related Irritability | 147 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Grade 3 Drowsiness | 5 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Related Temperature | 89 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Grade 3 Loss of appetite | 0 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Related Drowsiness | 110 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Grade 3 Irritability | 8 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Grade 3 Temperature | 2 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Any Temperature | 100 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Any Loss of appetite | 83 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Any Temperature | 103 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Grade 3 Temperature | 1 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Any Loss of appetite | 111 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Related Temperature | 93 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Any Irritability | 166 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Grade 3 Irritability | 1 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Grade 3 Loss of appetite | 2 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Any Drowsiness | 128 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Grade 3 Drowsiness | 3 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Related Irritability | 159 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Related Drowsiness | 121 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Related Loss of appetite | 101 Participants |
Secondary
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 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. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Irritability, Dose 3 | 132 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Loss of appetite, Dose 2 | 82 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Irritability, Dose 1 | 190 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Irritability, Across doses | 42 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Irritability, Dose 2 | 177 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Irritability, Dose 1 | 18 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Drowsiness, Across doses | 227 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Irritability, Dose 2 | 14 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Irritability, Dose 1 | 186 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Irritability, Dose 3 | 19 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Irritability, Dose 2 | 181 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Loss of appetite, Dose 1 | 88 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Irritability, Across doses | 238 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Temperature, Dose 2 | 81 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Loss of appetite, Dose 1 | 3 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Loss of appetite, Dose 3 | 58 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Temperature, Dose 2 | 0 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Loss of appetite, Dose 1 | 85 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Irritability, Dose 3 | 138 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Temperature, Dose 2 | 82 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Drowsiness, Dose 2 | 157 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Loss of appetite, Across doses | 155 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Drowsiness, Dose 2 | 152 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Drowsiness, Dose 2 | 5 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Temperature, Across doses | 0 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Temperature, Dose 3 | 67 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Loss of appetite, Across doses | 4 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Drowsiness, Across doses | 14 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Temperature, Dose 3 | 0 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Loss of appetite, Across doses | 152 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Temperature, Dose 3 | 70 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Drowsiness, Dose 1 | 183 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Temperature, Across doses | 149 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Drowsiness, Dose 3 | 124 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Drowsiness, Dose 1 | 4 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Drowsiness, Across doses | 231 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Drowsiness, Dose 3 | 7 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Drowsiness, Dose 1 | 178 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Loss of appetite, Dose 3 | 63 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Drowsiness, Dose 3 | 127 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Temperature, Dose 1 | 88 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Irritability, Across doses | 241 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Loss of appetite, Dose 2 | 80 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Temperature, Dose 1 | 0 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Temperature, Across doses | 153 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Loss of appetite, Dose 2 | 1 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Temperature, Dose 1 | 88 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Irritability, Dose 2 | 12 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Drowsiness, Across doses | 219 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Temperature, Across doses | 124 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Temperature, Across doses | 0 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Temperature, Across doses | 120 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Irritability, Across doses | 230 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Irritability, Across doses | 37 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Irritability, Across doses | 227 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Loss of appetite, Across doses | 145 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Loss of appetite, Across doses | 4 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Loss of appetite, Across doses | 144 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Drowsiness, Dose 1 | 171 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Drowsiness, Dose 1 | 7 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Drowsiness, Dose 1 | 171 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Temperature, Dose 1 | 63 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Temperature, Dose 1 | 0 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Temperature, Dose 1 | 62 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Irritability, Dose 1 | 185 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Irritability, Dose 1 | 18 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Irritability, Dose 1 | 182 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Loss of appetite, Dose 1 | 94 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Loss of appetite, Dose 1 | 94 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Drowsiness, Dose 2 | 141 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Drowsiness, Dose 2 | 5 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Drowsiness, Dose 2 | 141 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Temperature, Dose 2 | 60 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Temperature, Dose 2 | 0 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Temperature, Dose 2 | 58 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Irritability, Dose 2 | 176 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Drowsiness, Across doses | 13 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Irritability, Dose 2 | 172 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Loss of appetite, Dose 2 | 73 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Loss of appetite, Dose 2 | 2 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Loss of appetite, Dose 2 | 69 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Drowsiness, Dose 3 | 114 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Drowsiness, Dose 3 | 3 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Drowsiness, Dose 3 | 111 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Temperature, Dose 3 | 50 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Temperature, Dose 3 | 0 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Temperature, Dose 3 | 47 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Irritability, Dose 3 | 137 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Irritability, Dose 3 | 15 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Irritability, Dose 3 | 133 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Loss of appetite, Dose 3 | 59 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Loss of appetite, Dose 3 | 2 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Loss of appetite, Dose 3 | 55 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Drowsiness, Across doses | 220 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Irritability, Across doses | 235 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Loss of appetite, Dose 2 | 85 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Temperature, Dose 1 | 0 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Loss of appetite, Dose 3 | 54 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Temperature, Dose 1 | 40 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Irritability, Dose 3 | 133 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Loss of appetite, Dose 2 | 81 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Drowsiness, Dose 1 | 160 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Temperature, Across doses | 106 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Drowsiness, Dose 3 | 118 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Drowsiness, Dose 1 | 6 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Drowsiness, Across doses | 213 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Drowsiness, Dose 3 | 1 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Drowsiness, Dose 1 | 164 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Loss of appetite, Dose 3 | 59 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Drowsiness, Dose 3 | 115 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Loss of appetite, Across doses | 148 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Temperature, Across doses | 0 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Temperature, Dose 3 | 38 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Loss of appetite, Across doses | 1 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Drowsiness, Across doses | 7 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Temperature, Dose 3 | 0 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Loss of appetite, Across doses | 153 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Drowsiness, Dose 2 | 1 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Drowsiness, Dose 2 | 143 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Temperature, Dose 3 | 34 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Drowsiness, Dose 2 | 141 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Loss of appetite, Dose 1 | 84 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Irritability, Across doses | 232 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Temperature, Dose 2 | 60 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Loss of appetite, Dose 1 | 1 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Temperature, Across doses | 110 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Temperature, Dose 2 | 0 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Loss of appetite, Dose 1 | 87 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Irritability, Dose 3 | 138 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Temperature, Dose 2 | 59 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Irritability, Dose 1 | 173 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Irritability, Across doses | 16 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Irritability, Dose 2 | 165 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Irritability, Dose 1 | 8 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Drowsiness, Across doses | 215 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Irritability, Dose 2 | 5 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Any Irritability, Dose 1 | 180 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Grade 3 Irritability, Dose 3 | 5 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Irritability, Dose 2 | 154 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Related Temperature, Dose 1 | 40 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms -Booster Vaccination
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 from injection site.
Time frame: During the 4-day (Days 0-3) post-vaccination period following booster dose
Population: The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Grade 3 Swelling | 27 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Any Redness | 175 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Any Swelling | 185 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Any Pain | 174 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Grade 3 Redness | 22 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Grade 3 Pain | 21 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Grade 3 Redness | 10 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Any Swelling | 146 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Grade 3 Pain | 21 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Grade 3 Swelling | 15 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Any Pain | 161 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Any Redness | 144 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Any Redness | 180 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Any Pain | 145 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Grade 3 Pain | 7 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Grade 3 Swelling | 11 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Grade 3 Redness | 10 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Any Swelling | 160 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
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 spreading beyond (\>) 30 millimeters from injection site.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Pain, Dose 2 | 130 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Redness, Dose 2 | 125 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Redness, Across doses | 197 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Pain, Dose 1 | 168 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Redness, Dose 2 | 4 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Pain, Across doses | 205 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Redness, Dose 1 | 7 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Swelling, Dose 2 | 143 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Swelling, Dose 3 | 4 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Redness, Across doses | 12 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Swelling, Dose 2 | 7 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Redness, Dose 1 | 105 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Pain, Dose 1 | 30 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Pain, Dose 3 | 100 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Swelling, Across doses | 205 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Swelling, Dose 1 | 140 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Pain, Dose 3 | 9 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Swelling, Dose 3 | 142 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Pain, Dose 2 | 11 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Redness, Dose 3 | 141 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Swelling, Across doses | 18 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Pain, Across doses | 42 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Redness, Dose 3 | 1 Participants |
| Synflorix + Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Swelling, Dose 1 | 12 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Redness, Dose 3 | 1 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Swelling, Dose 3 | 133 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Swelling, Dose 3 | 7 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Swelling, Dose 1 | 18 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Pain, Across doses | 193 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Pain, Dose 1 | 159 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Pain, Across doses | 40 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Redness, Across doses | 193 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Pain, Dose 2 | 120 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Swelling, Across doses | 199 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Swelling, Across doses | 29 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Pain, Dose 2 | 12 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Redness, Dose 1 | 134 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Redness, Dose 2 | 131 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Redness, Dose 2 | 8 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Swelling, Dose 2 | 135 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Redness, Dose 1 | 21 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Swelling, Dose 2 | 8 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Pain, Dose 3 | 87 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Pain, Dose 3 | 4 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Swelling, Dose 1 | 145 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Redness, Dose 3 | 119 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Redness, Across doses | 26 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Pain, Dose 1 | 31 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Redness, Dose 3 | 121 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Pain, Dose 1 | 142 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Pain, Dose 1 | 22 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Redness, Dose 1 | 120 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Redness, Dose 1 | 15 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Swelling, Dose 1 | 113 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Swelling, Dose 1 | 15 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Pain, Dose 2 | 104 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Pain, Dose 2 | 13 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Redness, Dose 2 | 121 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Redness, Dose 2 | 4 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Swelling, Dose 2 | 125 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Swelling, Dose 2 | 8 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Pain, Dose 3 | 73 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Pain, Dose 3 | 5 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Redness, Dose 3 | 1 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Swelling, Dose 3 | 118 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Swelling, Dose 3 | 10 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Pain, Across doses | 178 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Pain, Across doses | 29 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Redness, Across doses | 184 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Redness, Across doses | 19 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Any Swelling, Across doses | 179 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Grade 3 Swelling, Across doses | 24 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination.
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.
Time frame: Within the 31-day (Days 0-30) after booster vaccination
Population: The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination. | 106 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination. | 105 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination. | 105 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination.
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.
Time frame: Within the 31-day (Days 0-30) post-primary vaccination
Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix + Infanrix Hexa Group | Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination. | 181 Participants |
| Synflorix + Pediacel Group | Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination. | 177 Participants |
| Prevenar + Pediacel Group | Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination. | 185 Participants |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose.
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.
Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose. | Opsono-6A, Month 21 | 21.6 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose. | Opsono-19A, Month 21 | 12.6 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose. | Opsono-6A, Month 21 | 24.8 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose. | Opsono-19A, Month 21 | 9.1 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose. | Opsono-6A, Month 21 | 56.5 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose. | Opsono-19A, Month 21 | 9.6 Titers |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination.
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.
Time frame: Prior to (Month 9) and one month after the administration of the booster dose (Month 10)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Opsono-6A, Month 9 | 23.3 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Opsono-19A, Month 9 | 5.7 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Opsono-6A, Month 10 | 143.3 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Opsono-19A, Month 10 | 34.9 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Opsono-19A, Month 10 | 24.6 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Opsono-6A, Month 9 | 30.7 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Opsono-6A, Month 10 | 197.1 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Opsono-19A, Month 9 | 5.5 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Opsono-19A, Month 10 | 7.7 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Opsono-19A, Month 9 | 5.5 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Opsono-6A, Month 10 | 493.3 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Opsono-6A, Month 9 | 15.5 Titers |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination.
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 8.
Time frame: At Month 3, one month after the administration of the third vaccine dose
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination. | Opsono-6A | 23.2 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination. | Opsono-19A | 9 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination. | Opsono-6A | 25.4 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination. | Opsono-19A | 8 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination. | Opsono-6A | 33 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination. | Opsono-19A | 4.9 Titers |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.
Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-14, Month 21 | 93.1 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-5, Month 21 | 12.9 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-18C, Month 21 | 21.6 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-19F, Month 21 | 31.1 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-23F, Month 21 | 366.5 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-1, Month 21 | 10.9 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-6B, Month 21 | 77.7 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-4, Month 21 | 12 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-7F, Month 21 | 1982.9 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-9V, Month 21 | 465.9 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-14, Month 21 | 151.6 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-6B, Month 21 | 137.6 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-9V, Month 21 | 470 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-18C, Month 21 | 12.5 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-5, Month 21 | 13.7 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-1, Month 21 | 9.9 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-19F, Month 21 | 32.9 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-7F, Month 21 | 2205.6 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-23F, Month 21 | 706.1 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-4, Month 21 | 15.5 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-23F, Month 21 | 3879.8 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-1, Month 21 | 4.3 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-4, Month 21 | 45.2 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-5, Month 21 | 4.1 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-6B, Month 21 | 220 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-7F, Month 21 | 738.1 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-9V, Month 21 | 476.2 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-14, Month 21 | 238.7 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-18C, Month 21 | 15.3 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Opsono-19F, Month 21 | 15.1 Titers |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.
Time frame: Prior (Month 9) to and one month after the administration of the booster dose(Month 10)
Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-7F, Month 10 | 3936.5 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-18C, Month 9 | 8.2 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-1, Month 9 | 5.5 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-6B, Month 10 | 681.4 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-19F, Month 9 | 13.8 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-6B, Month 9 | 52 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-5, Month 10 | 149.3 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-23F, Month 9 | 314.1 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-23F, Month 10 | 2895.4 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-4, Month 10 | 1046.8 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-1, Month 10 | 208.8 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-18C, Month 10 | 720.7 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-7F, Month 9 | 818.9 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-19F, Month 10 | 435.7 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-14, Month 10 | 1534.2 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-9V, Month 9 | 267.2 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-5, Month 9 | 7.2 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-9V, Month 10 | 2512.9 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-14, Month 9 | 117.3 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-4, Month 9 | 11.3 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-18C, Month 10 | 385.9 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-1, Month 9 | 5.6 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-4, Month 9 | 15.3 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-5, Month 9 | 7 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-6B, Month 9 | 96.7 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-7F, Month 9 | 754.3 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-9V, Month 9 | 338.7 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-14, Month 9 | 142.5 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-18C, Month 9 | 6.8 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-19F, Month 9 | 15.4 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-23F, Month 9 | 350.4 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-1, Month 10 | 221.4 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-4, Month 10 | 1121.6 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-5, Month 10 | 132.4 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-6B, Month 10 | 763.3 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-7F, Month 10 | 3976 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-9V, Month 10 | 2257.6 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-14, Month 10 | 1896.3 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-19F, Month 10 | 475.4 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-23F, Month 10 | 2895.3 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-4, Month 9 | 12.3 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-6B, Month 10 | 1807.5 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-14, Month 9 | 156 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-23F, Month 10 | 12418.7 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-7F, Month 10 | 129.1 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-9V, Month 9 | 149.5 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-19F, Month 10 | 123.2 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-9V, Month 10 | 3889.5 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-7F, Month 9 | 138.1 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-1, Month 9 | 5 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-14, Month 10 | 1867.9 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-6B, Month 9 | 27.4 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-1, Month 10 | 4.6 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-23F, Month 9 | 338.9 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-5, Month 9 | 4.3 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-4, Month 10 | 2335.8 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-19F, Month 9 | 7.8 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-18C, Month 10 | 660.4 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-5, Month 10 | 4.1 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Opsono-18C, Month 9 | 7 Titers |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.
Time frame: At Month 3, one month after the administration of the third vaccine dose
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-1 | 20.7 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-4 | 592.9 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-5 | 54.8 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-6B | 261.3 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-7F | 2063.3 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-9V | 863.6 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-14 | 990.4 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-18C | 122.6 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-19F | 133 Titers |
| Synflorix + Infanrix Hexa Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-23F | 847.4 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-19F | 143.8 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-1 | 20.8 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-9V | 1277.7 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-7F | 2136.1 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-4 | 600.4 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-23F | 1089 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-18C | 84.2 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-5 | 60.1 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-14 | 1086.4 Titers |
| Synflorix + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-6B | 296.4 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-18C | 213.6 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-6B | 633 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-7F | 18.4 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-9V | 1194 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-19F | 39.2 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-14 | 1373.3 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-1 | 4.7 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-23F | 3703.4 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-4 | 838.4 Titers |
| Prevenar + Pediacel Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Opsono-5 | 4.2 Titers |