Infections, Streptococcal
Conditions
Keywords
Otitis media, Pneumonia, Community acquired pneumonia (CAP), Pneumococcal disease, Booster vaccination, Immunogenicity, Pneumococcal vaccine, Safety, Efficacy, Carriage
Brief summary
This is a study in a large number of healthy children less than 3 years old to measure the efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate vaccine (Synflorix vaccine, or GSK1024850A) to prevent cases of pneumonia (lung infection) likely caused by bacteria (Streptococcus pneumoniae and Haemophilus influenzae) or cases of otitis media (ear infection) in children under 3 years old.
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The following vaccines will be offered by the sponsor: * Two doses of hepatitis A vaccine will be offered to all subjects to comply with national recommendations. * NeisVac-C vaccine against Neisseria meningitis group C will be offered to all subjects in Argentina at 12 months of age. * Varicella vaccine will be offered to all subjects in Colombia and Panama at 12 months of age. * Two doses of Rotarix vaccine will be offered to all subjects in Colombia within the first six months of life. In addition, all subjects will receive a dose of Hepatitis B vaccine at birth according to national recommendations and a dose of measles, mumps and rubella (MMR) vaccine at 12 to 15 months of age according to local Extended Program of Immunization (EPI) . These vaccines will not be provided by the sponsor. The protocol posting has been updated according to the amendment of the protocol dated 25 Nov 2008. The protocol posting has been updated according to the amendment of the protocol dated 14 December 2009. The protocol posting has been updated according to the amendment of the protocol dated 09 September 2010.
Interventions
Intramuscular injection, 4 doses
BIOLOGICALHavrix
Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group
BIOLOGICALEngerix-B
Intramuscular injection, 3 doses
BIOLOGICALInfanrix hexa
Intramuscular injection,3 doses
BIOLOGICALGSK Biologicals' DTPa-IPV/Hib vaccine
Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 16 Weeks
Healthy volunteers
Yes
Inclusion criteria
* A male or female between, and including, 6 and 16 weeks of age at the time of the first vaccination. Pre-term born infants can be included in the study starting from 8 weeks of chronological age at the time of first vaccination and up to 16 weeks of chronological age * Subjects should be living in the area covered by the surveillance system for community acquired pneumonia (CAP), invasive disease and acute otitis media (AOM) •Written informed consent obtained from the parent or guardian of the subject. * Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context. * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
Exclusion criteria
* Use of any investigational or non-registered drug or planned use during the study period. * Use or planned use of any investigational or non-registered vaccine other than the study vaccine(s). * Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or Streptococcus. pneumoniae . Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine .Other locally recommended vaccines are always allowed, even if concomitantly administered with the study vaccines. •Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar is not allowed. If Prevnar immunization needs to be initiated, due to the presence of a high risk disease for pneumococcal infections for which the Prevnar vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific Prevnar immunization program. * 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 * For Colombia: infants with low birth weight ( less than (\<) 2.500 grams)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) | Any time from 2 weeks after Dose 3 up to 31 August 2010 | A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (\>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose. After analysis on primary outcome was performed, re-monitoring activities revealed Informed Consent Form issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the study (Month 0 to Month 22-25) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset | Throughout the study (Month 0 to Month 22-25) | An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. The Panama Subset included all subjects from Panama. |
| Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration | Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group. |
| Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration | Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group. |
| Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group | Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration. | Assessed symptoms were redness, swelling and pain. The Immunogenicity and Safety Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group. |
| Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration | Assessed symptoms were fever (defined as rectal temperature equal or higher than \[\>=\] 38 degrees Celsius \[°C\]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration | Assessed symptoms were fever (defined as rectal temperature equal or higher than \[\>=\] 38 degrees Celsius \[°C\]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | CXR alveolar consolidation was defined as CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. CXR pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs. |
| Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Any Bacterial Pathogen, in the Panama Subset | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | The Panama Subset contained all subjects enrolled in Panama. |
| Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes, in the Panama Subset | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Panama Subset contained all subjects enrolled in Panama. |
| Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes, in the Panama Subset. | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 6A, 18B, 19A and 23A. The Panama Subset contained all subjects enrolled in Panama. |
| Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other Pneumococcal Serotypes, in the Panama Subset. | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | Other pneumococcal serotypes were defined for this outcome measures as non-Streptococcus pneumoniae vaccine and cross-reactive serotypes. The Panama Subset contained all subjects enrolled in Panama. |
| Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Haemophilus Influenzae (H. Influenzae), in the Panama Subset | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | The Panama Subset contained all subjects enrolled in Panama. |
| Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Non-typeable Haemophilus Influenzae (H. Influenzae), in the Panama Subset | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | The Panama Subset contained all subjects enrolled in Panama |
| Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other AOM Pathogens, in the Panama Subset | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | Other pathogens assessed included among others Moraxella catarrhalis, Group A streptococci, and Staphyloccus aureus. The Panama Subset contained all subjects enrolled in Panama. |
| Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) With Positive Respiratory Viral Test (RVT) | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | A CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs. |
| Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal CXR With Positive Respiratory Viral Test (RVT) | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | An abnormal CXR was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs. |
| Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) With Positive Respiratory Viral Test (RVT). | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | — |
| Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | An episode of S-CAP involved either any subject who was referred to have a chest X-ray (CXR) performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI. |
| Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal Chest X-ray (CXR) | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | An abnormal CXR was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs. |
| Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | A case of S-CAP involved either any subject who was referred to have a CXR performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI. CRP cut-off values applied for this outcome measure were 40 milligrams per liter (mg/L), 80 mg/L, and 120 mg/L. |
| Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off. | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | CRP cut-off values applied for this outcome measure were 80 milligrams per liter (mg/L), and 120 mg/L. |
| Number of Subjects With a First Episode Reported of Vaccine-type Invasive Pneumococcal Disease (VT-IPD). | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | A VT-IPD was defined as a bacteriologically culture confirmed invasive pneumococcal disease case caused by any of the 10 pneumococcal Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
| Number of Subjects With a First Episode Reported of a Bacteriologically Confirmed Invasive Pneumococcal Disease (Bact.-Conf. ID). | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | A Bact.-conf. ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes as identified through positive culture. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
| Number of Subjects With a First Episode Reported of Pneumococcal Invasive Disease (Pneumococcal ID) | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | A Pneumococcal ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Pneumococcal ID cases were identified through non-culture pneumococcal diagnostic tests with additional non-culture vaccine type serotyping. Tests used included rapid in-vitro diagnostic tests or Latex agglutination. |
| Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Streptococcus (S. pn.) Cross-reactive Pneumococcal Serotypes. | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 19A, 6A and 9N. |
| Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Pneumococcal Serotypes Other Than Streptococcus (S. pn.) Vaccine and Cross-reactive Serotypes. | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | The serotypes assessed for this outcome measure included among others the pneumococcal serotypes 12F, 16F, 24F, 38 and 8. |
| Number of Subjects With a First Episode Reported of Invasive Disease (ID) Due to Haemophilus Influenzae | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | No subject was reported with any case of ID due to Haemophilus influenzae. |
| Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25 | The 10 pneumococcal S. pn. vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama. |
| Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25 | Any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for this analysis of carriage S. pn. cross-reactive serotypes. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama. |
| Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25 | S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama. |
| Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25 | Results included samples confirmed as positive for Haemophilus influenzae (H. influenzae) or non-typeable H. influenzae (NTHi) after differentiation from H. haemolyticus by polymerase chain reaction (PCR) assay. The Carriage Subset contained a subgroup of 2,000 subjects enrolled in Panama. |
| Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | At Months 10-13, 13-16, 14-17, 16-19 and 22-25 | The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama. |
| Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. | At Months 10-13, 13-16, 14-17, 16-19 and 22-25 | The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama. |
| Number of Subjects With Any Antibiotic Prescription at Least Once During the Entire Study Period, in the Carriage Subset. | Throughout the study (Month 0 to Month 22-25) | The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama. |
| Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | At Month 5, one month after the third dose of primary vaccination | Antibody concentrations were measured by 22F enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was \>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | At Month 5, one month after the third dose of primary vaccination | Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was \>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) | Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was \>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | At Month 5, one month after the third dose of primary vaccination | Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | At Month 5, one month after the third dose of primary vaccination | Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) | Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | At Month 5, one month after the third dose of primary vaccination | A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F =\> 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | At Month 5, one month after the third dose of primary vaccination | A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A\>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | At Month 5, one month after the third dose of primary vaccination, | The cut-off of the assay was \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | At Month 5, one month after the third dose of primary vaccination | The cut-off of the assay was \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) | The cut-off of the assay was \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | At Month 5, one month after the third dose of primary vaccination | A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With a First Episode Reported of Clinically Confirmed Acute Otitis Media (AOM) (C-AOM), in the Panama Subset | Any time from 2 weeks after Dose 3 to study end at Month 22-25 | The Panama Subset contained all subjects enrolled in Panama. |
| Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) | A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST). | A seropositive subject was a subject with titers for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset | At Month 5, one month after the third dose of primary vaccination | ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset | At Month 5, one month after the third dose of primary vaccination | A seropositive subject was defined as a subject with ANTI-PD antibody concentrations \>= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset. | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST | A seropositive subject was defined as a subject with ANTI-PD antibody concentrations \>= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
| Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | At Month 5, one month after the third dose of primary vaccination | A seropositive subject was defined as a subject with titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. |
Countries
Argentina, Colombia, Panama
Participant flow
Recruitment details
Analysis on the primary outcome was performed when at least 535 first bacterial CAP episodes were reported from 2 weeks after vaccine Dose 3 (31 August 2010) with 23738 subjects (11875 and 11863 in Synflorix and Control groups) and analysis at study end was performed on 23597 subjects.
Participants by arm
| Arm | Count |
|---|---|
| Synflorix Group Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose). | 11,798 |
| Control Group Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh. | 11,799 |
| Total | 23,597 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Primary Outcome Analysis Period | Other: study still ongoing | 11,875 | 11,863 |
| Study End Analysis Period | Adverse Event | 35 | 43 |
| Study End Analysis Period | Lost to Follow-up | 1,137 | 1,167 |
| Study End Analysis Period | Other - Forbidden vaccination | 21 | 10 |
| Study End Analysis Period | Other - Subject without a legal guardian | 1 | 0 |
| Study End Analysis Period | Other - Unconformity in team's treatment | 0 | 1 |
| Study End Analysis Period | Physician Decision | 29 | 29 |
| Study End Analysis Period | Protocol Violation | 9 | 17 |
| Study End Analysis Period | Withdrawal by Subject | 1,264 | 1,267 |
Baseline characteristics
| Characteristic | Synflorix Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 9.2 Weeks STANDARD_DEVIATION 1.93 | 9.2 Weeks STANDARD_DEVIATION 1.92 | 9.2 Weeks STANDARD_DEVIATION 1.92 |
| Region of Enrollment Argentina | 6990 Subjects | 6991 Subjects | 13981 Subjects |
| Region of Enrollment Columbia | 1206 Subjects | 1196 Subjects | 2402 Subjects |
| Region of Enrollment Panama | 3602 Subjects | 3612 Subjects | 7214 Subjects |
| Sex: Female, Male Female | 5796 Participants | 5767 Participants | 11563 Participants |
| Sex: Female, Male Male | 6002 Participants | 6032 Participants | 12034 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 19 / 11,798 | 26 / 11,799 |
| other Total, other adverse events | 3,530 / 3,602 | 3,518 / 3,612 |
| serious Total, serious adverse events | 2,534 / 11,798 | 2,668 / 11,799 |
Outcome results
Primary
Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP)
A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (\>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose. After analysis on primary outcome was performed, re-monitoring activities revealed Informed Consent Form issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome.
Time frame: Any time from 2 weeks after Dose 3 up to 31 August 2010
Population: Analysis was performed on the Interim ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of 31 August 2010.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) | 240 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) | 304 Subjects |
Secondary
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was \>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-6A, PRE (N=231;214) | 0.22 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-6A, M1 POST-BST (N=219;204) | 1.14 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-6A, M9 POST-BST (N=206;183) | 0.31 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-19A, PRE (N=229;212) | 0.25 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-19A, M1 POST-BST (N=218;201) | 1.34 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-19A, M9 POST-BST (N=206;181) | 0.54 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-19A, M1 POST-BST (N=218;201) | 0.06 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-6A, PRE (N=231;214) | 0.04 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-19A, PRE (N=229;212) | 0.05 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-6A, M1 POST-BST (N=219;204) | 0.04 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-19A, M9 POST-BST (N=206;181) | 0.09 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-6A, M9 POST-BST (N=206;183) | 0.05 µg/mL |
Secondary
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was \>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: At Month 5, one month after the third dose of primary vaccination
Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-6A (N=334;321) | 0.32 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-19A (N=334;326) | 0.29 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-6A (N=334;321) | 0.03 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ANTI-19A (N=334;326) | 0.04 µg/mL |
Secondary
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was \>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-9V, PRE (N=230;214) | 1.14 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-5, M9 POST-BST (N=206;182) | 1.19 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-9V, M1 POST-BST (N=218;203) | 7.34 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-1, M1 POST-BST (N=219;196) | 3.58 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-9V, M9 POST-BST (N=206;182) | 1.80 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-6B, PRE (N=229;212) | 0.55 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-14, PRE (N=231;214) | 1.15 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-4, M9 POST-BST (N=206;183) | 0.87 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-14, M1 POST-BST (N=219;200) | 9.31 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-6B, M1 POST-BST (N=217;198) | 3.32 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-14, M9 POST-BST (N=206;183) | 1.98 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-4, PRE (N=231;214) | 0.48 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-18C, PRE (N=231;210) | 0.90 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-6B, M9 POST-BST (N=206;182) | 0.83 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-18C, M1 POST-BST (N=219;203) | 16.38 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-5, PRE (N=231;209) | 0.90 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-18C, M9 POST-BST (N=206;181) | 2.50 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-7F, PRE (N=231;210) | 0.94 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-19F, PRE (N=231;206) | 1.27 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-1, M9 POST-BST (N=206;181) | 0.65 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-19F, M1 POST-BST (N=219;198) | 9.40 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-7F, M1 POST-BST (N=218;198) | 5.77 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-19F, M9 POST-BST (N=205;181) | 2.47 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-5, M1 POST-BST (N=219;199) | 5.73 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-23F, PRE (N=229;204) | 0.62 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-7F, M9 POST-BST (N=206;182) | 1.32 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-23F, M1 POST-BST (N=218;201) | 4.02 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-4, M1 POST-BST (N=217;204) | 6.55 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-23F, M9 POST-BST (N=206;179) | 0.92 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-1, PRE (N=231;203) | 0.35 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-23F, M9 POST-BST (N=206;179) | 0.05 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-1, PRE (N=231;203) | 0.05 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-1, M1 POST-BST (N=219;196) | 0.06 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-1, M9 POST-BST (N=206;181) | 0.06 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-4, PRE (N=231;214) | 0.04 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-4, M1 POST-BST (N=217;204) | 0.05 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-4, M9 POST-BST (N=206;183) | 0.04 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-5, PRE (N=231;209) | 0.07 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-5, M1 POST-BST (N=219;199) | 0.07 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-5, M9 POST-BST (N=206;182) | 0.09 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-6B, PRE (N=229;212) | 0.04 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-6B, M1 POST-BST (N=217;198) | 0.04 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-6B, M9 POST-BST (N=206;182) | 0.05 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-7F, PRE (N=231;210) | 0.06 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-7F, M1 POST-BST (N=218;198) | 0.06 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-7F, M9 POST-BST (N=206;182) | 0.07 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-9V, PRE (N=230;214) | 0.04 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-9V, M1 POST-BST (N=218;203) | 0.04 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-9V, M9 POST-BST (N=206;182) | 0.05 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-14, PRE (N=231;214) | 0.11 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-14, M1 POST-BST (N=219;200) | 0.12 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-14, M9 POST-BST (N=206;183) | 0.17 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-18C, PRE (N=231;210) | 0.05 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-18C, M1 POST-BST (N=219;203) | 0.05 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-18C, M9 POST-BST (N=206;181) | 0.05 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-19F, PRE (N=231;206) | 0.06 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-19F, M1 POST-BST (N=219;198) | 0.07 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-19F, M9 POST-BST (N=205;181) | 0.10 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-23F, PRE (N=229;204) | 0.04 µg/mL |
| Control Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-23F, M1 POST-BST (N=218;201) | 0.04 µg/mL |
Secondary
Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset
ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST)
Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset | ANTI-PD, PRE (N=230;211) | 638.6 EL.U/mL |
| Synflorix Group | Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset | ANTI-PD, M1 POST BST (N=218;195) | 2787.0 EL.U/mL |
| Synflorix Group | Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset | ANTI-PD, M9 POST-BST (N=206;182) | 824.1 EL.U/mL |
| Control Group | Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset | ANTI-PD, PRE (N=230;211) | 103.1 EL.U/mL |
| Control Group | Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset | ANTI-PD, M1 POST BST (N=218;195) | 92.4 EL.U/mL |
| Control Group | Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset | ANTI-PD, M9 POST-BST (N=206;182) | 94.5 EL.U/mL |
Secondary
Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset
ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: At Month 5, one month after the third dose of primary vaccination
Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix Group | Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset | 2455.2 EL.U/mL |
| Control Group | Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset | 101.2 EL.U/mL |
Secondary
Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset.
The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
Time frame: At Months 10-13, 13-16, 14-17, 16-19 and 22-25
Population: The analysis was performed on all vaccinated subjects included in the carriage subset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 22-25 (N=628;640) | 28 Subjects |
| Synflorix Group | Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 10-13 (N=788;785) | 39 Subjects |
| Synflorix Group | Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 13-16 (N=757;762) | 27 Subjects |
| Synflorix Group | Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 14-17 (N=720;737) | 23 Subjects |
| Synflorix Group | Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 16-19 (N=696;690) | 22 Subjects |
| Control Group | Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 16-19 (N=696;690) | 32 Subjects |
| Control Group | Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 14-17 (N=720;737) | 28 Subjects |
| Control Group | Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 10-13 (N=788;785) | 37 Subjects |
| Control Group | Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 22-25 (N=628;640) | 31 Subjects |
| Control Group | Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 13-16 (N=757;762) | 33 Subjects |
Secondary
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset
The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
Time frame: At Months 10-13, 13-16, 14-17, 16-19 and 22-25
Population: The analysis was performed on all vaccinated subjects included in the carriage subset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 13-16 (N=758;762) | 145 Subjects |
| Synflorix Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 16-19 (N=696;690) | 126 Subjects |
| Synflorix Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 14-17 (N=720;738) | 110 Subjects |
| Synflorix Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 22-25;N=627;639) | 123 Subjects |
| Synflorix Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 10-13 (N=788;784) | 171 Subjects |
| Control Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 22-25;N=627;639) | 124 Subjects |
| Control Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 10-13 (N=788;784) | 175 Subjects |
| Control Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 13-16 (N=758;762) | 165 Subjects |
| Control Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 14-17 (N=720;738) | 137 Subjects |
| Control Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 16-19 (N=696;690) | 137 Subjects |
Secondary
Number of Subjects With a First Episode Reported of a Bacteriologically Confirmed Invasive Pneumococcal Disease (Bact.-Conf. ID).
A Bact.-conf. ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes as identified through positive culture. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of a Bacteriologically Confirmed Invasive Pneumococcal Disease (Bact.-Conf. ID). | 6 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of a Bacteriologically Confirmed Invasive Pneumococcal Disease (Bact.-Conf. ID). | 17 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) With Positive Respiratory Viral Test (RVT).
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) With Positive Respiratory Viral Test (RVT). | 35 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) With Positive Respiratory Viral Test (RVT). | 39 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Any Bacterial Pathogen, in the Panama Subset
The Panama Subset contained all subjects enrolled in Panama.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Any Bacterial Pathogen, in the Panama Subset | 32 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Any Bacterial Pathogen, in the Panama Subset | 45 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Haemophilus Influenzae (H. Influenzae), in the Panama Subset
The Panama Subset contained all subjects enrolled in Panama.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Haemophilus Influenzae (H. Influenzae), in the Panama Subset | 12 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Haemophilus Influenzae (H. Influenzae), in the Panama Subset | 14 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Non-typeable Haemophilus Influenzae (H. Influenzae), in the Panama Subset
The Panama Subset contained all subjects enrolled in Panama
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Non-typeable Haemophilus Influenzae (H. Influenzae), in the Panama Subset | 12 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Non-typeable Haemophilus Influenzae (H. Influenzae), in the Panama Subset | 14 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other AOM Pathogens, in the Panama Subset
Other pathogens assessed included among others Moraxella catarrhalis, Group A streptococci, and Staphyloccus aureus. The Panama Subset contained all subjects enrolled in Panama.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other AOM Pathogens, in the Panama Subset | 8 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other AOM Pathogens, in the Panama Subset | 7 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other Pneumococcal Serotypes, in the Panama Subset.
Other pneumococcal serotypes were defined for this outcome measures as non-Streptococcus pneumoniae vaccine and cross-reactive serotypes. The Panama Subset contained all subjects enrolled in Panama.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other Pneumococcal Serotypes, in the Panama Subset. | 3 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other Pneumococcal Serotypes, in the Panama Subset. | 4 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes, in the Panama Subset.
The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 6A, 18B, 19A and 23A. The Panama Subset contained all subjects enrolled in Panama.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes, in the Panama Subset. | 3 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes, in the Panama Subset. | 4 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes, in the Panama Subset
The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Panama Subset contained all subjects enrolled in Panama.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes, in the Panama Subset | 6 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes, in the Panama Subset | 18 Subjects |
Secondary
Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off.
CRP cut-off values applied for this outcome measure were 80 milligrams per liter (mg/L), and 120 mg/L.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off. | C-CAP or NAI-CAP with CRP >= 120 mg/L | 191 Subjects |
| Synflorix Group | Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off. | C-CAP or NAI-CAP with CRP >= 80 mg/L | 208 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off. | C-CAP or NAI-CAP with CRP >= 80 mg/L | 256 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off. | C-CAP or NAI-CAP with CRP >= 120 mg/L | 240 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Clinically Confirmed Acute Otitis Media (AOM) (C-AOM), in the Panama Subset
The Panama Subset contained all subjects enrolled in Panama.
Time frame: Any time from 2 weeks after Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Clinically Confirmed Acute Otitis Media (AOM) (C-AOM), in the Panama Subset | 204 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Clinically Confirmed Acute Otitis Media (AOM) (C-AOM), in the Panama Subset | 239 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP)
CXR alveolar consolidation was defined as CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. CXR pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) | 181 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) | 231 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) With Positive Respiratory Viral Test (RVT)
A CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) With Positive Respiratory Viral Test (RVT) | 21 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) With Positive Respiratory Viral Test (RVT) | 25 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal Chest X-ray (CXR)
An abnormal CXR was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal Chest X-ray (CXR) | 681 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal Chest X-ray (CXR) | 764 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal CXR With Positive Respiratory Viral Test (RVT)
An abnormal CXR was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal CXR With Positive Respiratory Viral Test (RVT) | 104 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal CXR With Positive Respiratory Viral Test (RVT) | 112 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Invasive Disease (ID) Due to Haemophilus Influenzae
No subject was reported with any case of ID due to Haemophilus influenzae.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Secondary
Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Pneumococcal Serotypes Other Than Streptococcus (S. pn.) Vaccine and Cross-reactive Serotypes.
The serotypes assessed for this outcome measure included among others the pneumococcal serotypes 12F, 16F, 24F, 38 and 8.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Pneumococcal Serotypes Other Than Streptococcus (S. pn.) Vaccine and Cross-reactive Serotypes. | 3 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Pneumococcal Serotypes Other Than Streptococcus (S. pn.) Vaccine and Cross-reactive Serotypes. | 0 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Streptococcus (S. pn.) Cross-reactive Pneumococcal Serotypes.
The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 19A, 6A and 9N.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Streptococcus (S. pn.) Cross-reactive Pneumococcal Serotypes. | 2 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Streptococcus (S. pn.) Cross-reactive Pneumococcal Serotypes. | 1 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Pneumococcal Invasive Disease (Pneumococcal ID)
A Pneumococcal ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Pneumococcal ID cases were identified through non-culture pneumococcal diagnostic tests with additional non-culture vaccine type serotyping. Tests used included rapid in-vitro diagnostic tests or Latex agglutination.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Pneumococcal Invasive Disease (Pneumococcal ID) | 6 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Pneumococcal Invasive Disease (Pneumococcal ID) | 17 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP)
An episode of S-CAP involved either any subject who was referred to have a chest X-ray (CXR) performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) | 2108 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) | 2237 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading
A case of S-CAP involved either any subject who was referred to have a CXR performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI. CRP cut-off values applied for this outcome measure were 40 milligrams per liter (mg/L), 80 mg/L, and 120 mg/L.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading | S-CAP with CRP >= 40 mg/L regardless of CXR exam | 425 Subjects |
| Synflorix Group | Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading | S-CAP with CRP >= 80 mg/L regardless of CXR exam | 175 Subjects |
| Synflorix Group | Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading | S-CAP with CRP >= 120 mg/L regardless of CXR exam | 85 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading | S-CAP with CRP >= 40 mg/L regardless of CXR exam | 499 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading | S-CAP with CRP >= 80 mg/L regardless of CXR exam | 237 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading | S-CAP with CRP >= 120 mg/L regardless of CXR exam | 119 Subjects |
Secondary
Number of Subjects With a First Episode Reported of Vaccine-type Invasive Pneumococcal Disease (VT-IPD).
A VT-IPD was defined as a bacteriologically culture confirmed invasive pneumococcal disease case caused by any of the 10 pneumococcal Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With a First Episode Reported of Vaccine-type Invasive Pneumococcal Disease (VT-IPD). | 0 Subjects |
| Control Group | Number of Subjects With a First Episode Reported of Vaccine-type Invasive Pneumococcal Disease (VT-IPD). | 16 Subjects |
Secondary
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: At Month 5, one month after the third dose of primary vaccination
Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6A (N=334;321) | 215 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19A (N=334;326) | 204 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6A (N=334;321) | 5 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19A (N=334;326) | 18 Subjects |
Secondary
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: At Month 5, one month after the third dose of primary vaccination
Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1 (N=334;312) | 333 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4 (N=334;328) | 332 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5 (N=334;324) | 333 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANITI-6B (N=334;322) | 311 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F (N=334;330) | 333 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V (N=334;331) | 330 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14 (N=334;330) | 328 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C (N=334;328) | 330 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F (N=334;327) | 325 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F (N=334;331) | 321 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C (N=334;328) | 21 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1 (N=334;312) | 13 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V (N=334;331) | 19 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4 (N=334;328) | 11 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F (N=334;331) | 15 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5 (N=334;324) | 22 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14 (N=334;330) | 77 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANITI-6B (N=334;322) | 8 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F (N=334;327) | 40 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F (N=334;330) | 28 Subjects |
Secondary
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed with the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V, M9 POST-BST (N=206;182) | 206 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6B, M1 POST-BST (N=217;198) | 215 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14, PRE (N=231;214) | 217 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4, PRE (N=231;214) | 190 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14, M1 POST-BST (N=219;200) | 219 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6B, M9 POST-BST (N=206;182) | 192 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14, M9 POST-BST (N=206;183) | 204 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5, M1 POST-BST (N=219;199) | 219 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C, PRE (N=231;210) | 217 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F, PRE (N=231;210) | 222 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C, M1 POST-BST (N=219;203) | 219 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4, M9 POST-BST (N=206;183) | 198 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C, M9 POST-BST (N=206;181) | 205 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F, M1 POST-BST (N=218;198) | 218 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F, PRE (N=231;206) | 221 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5, M9 POST-BST (N=206;182) | 200 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F, M1 POST-BST (N=219;198) | 218 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F, M9 POST-BST (N=206;182) | 205 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F, M9 POST-BST (N=205;181) | 204 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4, M1 POST-BST (N=217;204) | 217 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F, PRE (N=229;204) | 198 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V, PRE (N=230;214) | 221 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F, M1 POST-BST (N=218;201) | 216 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6B, PRE (N=229;212) | 182 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F, M9 POST-BST (N=206;179) | 196 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V, M1 POST-BST (N=218;203) | 218 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1, PRE (N=231;203) | 164 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5, PRE (N=231;209) | 218 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1, M1 POST-BST (N=219;196) | 219 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1, M9 POST-BST (N=206;181) | 186 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1, M1 POST-BST (N=219;196) | 19 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1, M9 POST-BST (N=206;181) | 14 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4, PRE (N=231;214) | 26 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4, M1 POST-BST (N=217;204) | 24 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4, M9 POST-BST (N=206;183) | 15 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5, PRE (N=231;209) | 27 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5, M1 POST-BST (N=219;199) | 30 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5, M9 POST-BST (N=206;182) | 34 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6B, PRE (N=229;212) | 12 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6B, M1 POST-BST (N=217;198) | 13 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6B, M9 POST-BST (N=206;182) | 21 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F, PRE (N=231;210) | 34 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F, M1 POST-BST (N=218;198) | 36 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F, M9 POST-BST (N=206;182) | 31 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V, PRE (N=230;214) | 22 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V, M1 POST-BST (N=218;203) | 14 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V, M9 POST-BST (N=206;182) | 26 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14, PRE (N=231;214) | 51 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14, M1 POST-BST (N=219;200) | 52 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14, M9 POST-BST (N=206;183) | 68 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C, PRE (N=231;210) | 22 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C, M1 POST-BST (N=219;203) | 21 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C, M9 POST-BST (N=206;181) | 18 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F, PRE (N=231;206) | 35 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F, M1 POST-BST (N=219;198) | 39 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F, M9 POST-BST (N=205;181) | 52 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F, PRE (N=229;204) | 15 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F, M1 POST-BST (N=218;201) | 14 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F, M9 POST-BST (N=206;179) | 25 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1, PRE (N=231;203) | 14 Subjects |
Secondary
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset
A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F =\> 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: At Month 5, one month after the third dose of primary vaccination
Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1 (N=334;312) | 333 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4 (N=334;328) | 333 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5 (N=334;324) | 334 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANITI-6B (N=334;322) | 324 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F (N=334;330) | 333 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V (N=334;331) | 331 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14 (N=334;330) | 333 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C (N=334;328) | 333 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F (N=334;327) | 331 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F (N=334;331) | 328 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C (N=334;328) | 92 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1 (N=334;312) | 88 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V (N=334;331) | 68 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4 (N=334;328) | 48 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F (N=334;331) | 78 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5 (N=334;324) | 153 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14 (N=334;330) | 234 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANITI-6B (N=334;322) | 48 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F (N=334;327) | 176 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F (N=334;330) | 116 Subjects |
Secondary
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset
A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F =\> 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST
Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V, PRE (N=230;214) | 230 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5, M9 POST-BST (N=206;182) | 206 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V, M1 POST-BST (N=218;203) | 218 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1, M1 POST-BST (N=219;196) | 219 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V, M9 POST-BST (N=206;182) | 206 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6B, PRE (N=229;212) | 226 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14, PRE (N=231;214) | 231 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4, M9 POST-BST (N=206;183) | 206 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14, M1 POST-BST (N=219;200) | 219 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6B, M1 POST-BST (N=217;198) | 216 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14, M9 POST-BST (N=206;183) | 206 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4, PRE (N=231;214) | 231 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C, PRE (N=231;210) | 230 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6B, M9 POST-BST (N=206;182) | 206 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C, M1 POST-BST (N=219;203) | 219 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5, PRE (N=231;209) | 231 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C, M9 POST-BST (N=206;181) | 206 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F, PRE (N=231;210) | 231 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F, PRE (N=231;206) | 231 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1, M9 POST-BST (N=206;181) | 206 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F, M1 POST-BST (N=219;198) | 219 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F, M1 POST-BST (N=218;198) | 218 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F, M9 POST-BST (N=205;181) | 205 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5, M1 POST-BST (N=219;199) | 219 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F, PRE (N=229;204) | 223 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F, M9 POST-BST (N=206;182) | 206 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F, M1 POST-BST (N=218;201) | 216 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4, M1 POST-BST (N=217;204) | 217 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F, M9 POST-BST (N=206;179) | 206 Subjects |
| Synflorix Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1, PRE (N=231;203) | 231 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F, M9 POST-BST (N=206;179) | 62 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1, PRE (N=231;203) | 87 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1, M1 POST-BST (N=219;196) | 101 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-1, M9 POST-BST (N=206;181) | 95 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4, PRE (N=231;214) | 52 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4, M1 POST-BST (N=217;204) | 65 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-4, M9 POST-BST (N=206;183) | 58 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5, PRE (N=231;209) | 150 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5, M1 POST-BST (N=219;199) | 142 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-5, M9 POST-BST (N=206;182) | 133 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6B, PRE (N=229;212) | 60 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6B, M1 POST-BST (N=217;198) | 54 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6B, M9 POST-BST (N=206;182) | 72 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F, PRE (N=231;210) | 79 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F, M1 POST-BST (N=218;198) | 79 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-7F, M9 POST-BST (N=206;182) | 87 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V, PRE (N=230;214) | 51 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V, M1 POST-BST (N=218;203) | 58 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-9V, M9 POST-BST (N=206;182) | 68 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14, PRE (N=231;214) | 157 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14, M1 POST-BST (N=219;200) | 160 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-14, M9 POST-BST (N=206;183) | 154 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C, PRE (N=231;210) | 72 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C, M1 POST-BST (N=219;203) | 71 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-18C, M9 POST-BST (N=206;181) | 73 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F, PRE (N=231;206) | 71 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F, M1 POST-BST (N=219;198) | 85 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19F, M9 POST-BST (N=205;181) | 93 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F, PRE (N=229;204) | 44 Subjects |
| Control Group | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-23F, M1 POST-BST (N=218;201) | 44 Subjects |
Secondary
Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset
A seropositive subject was defined as a subject with ANTI-PD antibody concentrations \>= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: At Month 5, one month after the third dose of primary vaccination
Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset | 333 Subjects |
| Control Group | Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset | 141 Subjects |
Secondary
Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset.
A seropositive subject was defined as a subject with ANTI-PD antibody concentrations \>= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST
Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset. | ANTI-PD, PRE (N=230;211) | 223 Subjects |
| Synflorix Group | Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset. | ANTI-PD, M1 POST BST (N=218;195) | 218 Subjects |
| Synflorix Group | Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset. | ANTI-PD, M9 POST-BST (N=206;182) | 198 Subjects |
| Control Group | Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset. | ANTI-PD, PRE (N=230;211) | 96 Subjects |
| Control Group | Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset. | ANTI-PD, M1 POST BST (N=218;195) | 83 Subjects |
| Control Group | Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset. | ANTI-PD, M9 POST-BST (N=206;182) | 84 Subjects |
Secondary
Number of Subjects With Any Antibiotic Prescription at Least Once During the Entire Study Period, in the Carriage Subset.
The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
Time frame: Throughout the study (Month 0 to Month 22-25)
Population: The analysis was performed on all vaccinated subjects included in the carriage subset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With Any Antibiotic Prescription at Least Once During the Entire Study Period, in the Carriage Subset. | 611 Subjects |
| Control Group | Number of Subjects With Any Antibiotic Prescription at Least Once During the Entire Study Period, in the Carriage Subset. | 626 Subjects |
Secondary
Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. The Panama Subset included all subjects from Panama.
Time frame: Throughout the study (Month 0 to Month 22-25)
Population: The analysis was performed on all vaccinated subjects included in the Panama subset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset | 3530 Subjects |
| Control Group | Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset | 3518 Subjects |
Secondary
Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset
Results included samples confirmed as positive for Haemophilus influenzae (H. influenzae) or non-typeable H. influenzae (NTHi) after differentiation from H. haemolyticus by polymerase chain reaction (PCR) assay. The Carriage Subset contained a subgroup of 2,000 subjects enrolled in Panama.
Time frame: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25
Population: The analysis was performed on all vaccinated subjects included in the carriage subset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 5 (N=824; 820) | 36 Subjects |
| Synflorix Group | Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 10-13 (N=788;785) | 45 Subjects |
| Synflorix Group | Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 13-16 (N=757;762) | 32 Subjects |
| Synflorix Group | Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 14-17 (N=720; 737) | 28 Subjects |
| Synflorix Group | Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 16-19 (N=696; 690) | 28 Subjects |
| Synflorix Group | Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 22-25 (N=628; 640) | 29 Subjects |
| Control Group | Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 16-19 (N=696; 690) | 38 Subjects |
| Control Group | Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 5 (N=824; 820) | 40 Subjects |
| Control Group | Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 14-17 (N=720; 737) | 34 Subjects |
| Control Group | Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 10-13 (N=788;785) | 44 Subjects |
| Control Group | Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 22-25 (N=628; 640) | 33 Subjects |
| Control Group | Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset | Month 13-16 (N=757;762) | 39 Subjects |
Secondary
Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6A, M1 POST-BST (N=219;204) | 187 Subjects |
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19A, PRE (N=229;212) | 131 Subjects |
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6A, PRE (N=231;214) | 119 Subjects |
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19A, M1 POST-BST (N=218;201) | 197 Subjects |
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6A, M9 POST-BST (N=206;183) | 129 Subjects |
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19A, M9 POST-BST (N=206;181) | 165 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6A, M9 POST-BST (N=206;183) | 24 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6A, PRE (N=231;214) | 14 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-6A, M1 POST-BST (N=219;204) | 12 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19A, M9 POST-BST (N=206;181) | 47 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19A, PRE (N=229;212) | 28 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | ANTI-19A, M1 POST-BST (N=218;201) | 27 Subjects |
Secondary
Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset
A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A\>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: At Month 5, one month after the third dose of primary vaccination
Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-6A (N=334;321) | 306 Subjects |
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-19A (N=334;326) | 303 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-6A (N=334;321) | 77 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-19A (N=334;326) | 120 Subjects |
Secondary
Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset
A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A\>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) .
Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-6A, PRE (N=231;214) | 210 Subjects |
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-6A, M1 POST-BST (N=219;204) | 214 Subjects |
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-6A, M9 POST-BST (N=206;183) | 196 Subjects |
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-19A, PRE (N=229;212) | 208 Subjects |
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-19A, M1 POST-BST (N=218;201) | 212 Subjects |
| Synflorix Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-19A, M9 POST-BST (N=206;181) | 201 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-19A, M1 POST-BST (N=218;201) | 83 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-6A, PRE (N=231;214) | 61 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-19A, PRE (N=229;212) | 76 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-6A, M1 POST-BST (N=219;204) | 61 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-19A, M9 POST-BST (N=206;181) | 89 Subjects |
| Control Group | Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | ANTI-6A, M9 POST-BST (N=206;183) | 69 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Throughout the study (Month 0 to Month 22-25)
Population: The analysis was performed on all vaccinated subjects whose data were exploited towards analysis of results at the end of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 2534 Subjects |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | 2668 Subjects |
Secondary
Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset
Assessed symptoms were fever (defined as rectal temperature equal or higher than \[\>=\] 38 degrees Celsius \[°C\]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration
Population: The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Drowsiness | 74 Subjects |
| Synflorix Group | Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Fever (rectal temperature >= 38°C) | 93 Subjects |
| Synflorix Group | Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Irritability | 121 Subjects |
| Synflorix Group | Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Loss of appetite | 51 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Loss of appetite | 46 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Drowsiness | 65 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Irritability | 95 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Fever (rectal temperature >= 38°C) | 73 Subjects |
Secondary
Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset
Assessed symptoms were fever (defined as rectal temperature equal or higher than \[\>=\] 38 degrees Celsius \[°C\]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration
Population: The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Drowsiness | 236 Subjects |
| Synflorix Group | Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Fever (rectal temperature >= 38°C) | 247 Subjects |
| Synflorix Group | Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Irritability | 289 Subjects |
| Synflorix Group | Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Loss of appetite | 133 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Loss of appetite | 80 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Drowsiness | 168 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Irritability | 206 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Fever (rectal temperature >= 38°C) | 125 Subjects |
Secondary
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset
Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.
Time frame: Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration
Population: The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Pain after vaccination with Synflorix | 129 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Pain after vaccination with Infanrix-IPV/Hib | 131 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Redness after vaccination with Synflorix | 104 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Redness after vaccination with Infanrix-IPV/Hib | 98 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Swelling after vaccination with Synflorix | 74 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset | Swelling after vaccination with Infanrix-IPV/Hib | 69 Subjects |
Secondary
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group
Assessed symptoms were redness, swelling and pain. The Immunogenicity and Safety Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.
Time frame: Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration.
Population: The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group | Pain after vaccination with Infanrix-IPV/Hib | 81 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group | Pain after vaccination with Havrix | 89 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group | Redness after vaccination with Infanrix-IPV/Hib | 81 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group | Redness after vaccination with Havrix | 73 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group | Swelling after vaccination with Infanrix-IPV/Hib | 70 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group | Swelling after vaccination with Havrix | 55 Subjects |
Secondary
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset
Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.
Time frame: Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration
Population: The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Pain after vaccination with Infanrix-IPV/Hib | 169 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Pain after vaccination with Engerix | 165 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Redness after vaccination with Infanrix-IPV/Hib | 118 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Redness after vaccination with Engerix | 109 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Swelling after vaccination with Infanrix-IPV/Hib | 98 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Swelling after vaccination with Engerix | 91 Subjects |
Secondary
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset
Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.
Time frame: Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration
Population: The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Pain after vaccination with Synflorix | 275 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Pain after vaccination with Infanrix Hexa | 270 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Redness after vaccination with Synflorix | 182 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Redness after vaccination with Infanrix Hexa | 171 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Swelling after vaccination with Synflorix | 141 Subjects |
| Synflorix Group | Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset | Swelling after vaccination with Infanrix Hexa | 143 Subjects |
Secondary
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset.
Any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for this analysis of carriage S. pn. cross-reactive serotypes. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
Time frame: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25
Population: The analysis was performed on all vaccinated subjects included in the carriage subset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 5 (N=814; 814) | 63 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 10-13 (N=788; 784) | 81 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 13-16 (N=758; 762) | 57 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 14-17 (N=720; 738) | 57 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 16-19 (N=696; 690) | 55 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 22-25 (N=627; 639) | 38 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 16-19 (N=696; 690) | 57 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 5 (N=814; 814) | 67 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 14-17 (N=720; 738) | 49 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 10-13 (N=788; 784) | 63 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 22-25 (N=627; 639) | 46 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 13-16 (N=758; 762) | 63 Subjects |
Secondary
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset
S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
Time frame: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25
Population: The analysis was performed on all vaccinated subjects included in the carriage subset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | Month 5 (N=814; 814) | 99 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | Month 10-13 (N=788; 784) | 85 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | Month 13-16 (N=758; 762) | 83 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | Month 14-17 (N=720; 738) | 78 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | Month 16-19 (N=696; 690) | 89 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | Month 22-25 (N=627; 639) | 74 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | Month 16-19 (N=696; 690) | 69 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | Month 5 (N=814; 814) | 86 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | Month 14-17 (N=720; 738) | 85 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | Month 10-13 (N=788; 784) | 85 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | Month 22-25 (N=627; 639) | 61 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset | Month 13-16 (N=758; 762) | 85 Subjects |
Secondary
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset.
The 10 pneumococcal S. pn. vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
Time frame: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25
Population: The analysis was performed on all vaccinated subjects included in the carriage subset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 5 (N=814; 814) | 104 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 10-13 (N=788; 784) | 92 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 13-16 (N=758; 762) | 88 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 14-17 (N=720; 738) | 74 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 16-19 (N=696; 690) | 68 Subjects |
| Synflorix Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 22-25 (N=627; 639) | 61 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 16-19 (N=696; 690) | 98 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 5 (N=814; 814) | 123 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 14-17 (N=720; 738) | 103 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 10-13 (N=788; 784) | 123 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 22-25 (N=627; 639) | 86 Subjects |
| Control Group | Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. | Month 13-16 (N=758; 762) | 109 Subjects |
Secondary
Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset
A seropositive subject was defined as a subject with titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: At Month 5, one month after the third dose of primary vaccination
Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6A (N=297;305) | 232 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19A (N=302;309) | 121 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6A (N=297;305) | 16 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19A (N=302;309) | 5 Subjects |
Secondary
Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset
A seropositive subject was a subject with titers for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST).
Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6A, PRE (N=189;194) | 99 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6A, M1 POST BST (N=185;185) | 150 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6A, M9 POST-BST (N=175;156) | 104 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19A, PRE (N=217;204) | 32 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19A, M1 POST-BST (N=200;197) | 161 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19A, M9 POST-BST (N=187;171) | 108 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19A, M1 POST-BST (N=200;197) | 20 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6A, PRE (N=189;194) | 24 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19A, PRE (N=217;204) | 14 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6A, M1 POST BST (N=185;185) | 26 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19A, M9 POST-BST (N=187;171) | 32 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6A, M9 POST-BST (N=175;156) | 50 Subjects |
Secondary
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset
A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: At Month 5, one month after the third dose of primary vaccination
Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-1 (N=306;305) | 280 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-4 (N=310;299) | 306 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-5 (N=313;314) | 303 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-6B (N=315;309) | 286 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-7F (N=302;266) | 302 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-9V (N=312;302) | 311 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-14 (N=308;273) | 306 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-18C (N=308;317) | 290 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-19F (N=304;314) | 277 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-23F (N=317;282) | 311 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-18C (N=308;317) | 8 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-1 (N=306;305) | 25 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-9V (N=312;302) | 98 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-4 (N=310;299) | 15 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-23F (N=317;282) | 68 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-5 (N=313;314) | 13 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-14 (N=308;273) | 95 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-6B (N=315;309) | 16 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-19F (N=304;314) | 16 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | OPSONO-7F (N=302;266) | 162 Subjects |
Secondary
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset
A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-9V, PRE (N=213;188) | 212 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-5, M9 POST-BST (N=192;173) | 157 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-9V, M1 POST-BST (N=200;189) | 200 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-1, M1 POST-BST (N=209;200) | 195 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-9V, M9 POST-BST (N=194;168) | 194 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6B, PRE (N=209;197) | 162 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-14, PRE (N=205;192) | 158 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-4, M9 POST-BST (N=192;173) | 147 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-14, M1 POST-BST (N=209;188) | 208 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6B, M1 POST-BST (N=203;190) | 200 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-14, M9 POST-BST (N=185;159) | 160 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-4, PRE (N=208;193) | 108 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-18C, PRE (N=204;191) | 86 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6B, M9 POST-BST (N=178;165) | 146 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-18C, M1 POST-BST (N=188;187) | 187 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-5, PRE (N=205;204) | 138 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-18C, M9 POST-BST (N=170;164) | 165 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-7F, PRE (N=217;202) | 217 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19F, PRE (N=218;205) | 150 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-1, M9 POST-BST (N=196;176) | 127 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19F, M1 POST-BST (N=199;200) | 186 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-7F, M1 POST-BST (N=205;196) | 203 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19F, M9 POST-BST (N=194;170) | 168 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-5, M1 POST-BST (N=196;187) | 194 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-23F, PRE (N=215;199) | 190 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-7F, M9 POST-BST (N=192;172) | 192 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-23F, M1 POST-BST (N=206;190) | 205 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-4, M1 POST-BST (N=207;193) | 206 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-23F, M9 POST-BST (N=187;167) | 167 Subjects |
| Synflorix Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-1, PRE (N=221;210) | 58 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-23F, M9 POST-BST (N=187;167) | 85 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-1, PRE (N=221;210) | 9 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-1, M1 POST-BST (N=209;200) | 14 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-1, M9 POST-BST (N=196;176) | 10 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-4, PRE (N=208;193) | 25 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-4, M1 POST-BST (N=207;193) | 26 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-4, M9 POST-BST (N=192;173) | 22 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-5, PRE (N=205;204) | 7 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-5, M1 POST-BST (N=196;187) | 10 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-5, M9 POST-BST (N=192;173) | 3 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6B, PRE (N=209;197) | 27 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6B, M1 POST-BST (N=203;190) | 23 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-6B, M9 POST-BST (N=178;165) | 35 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-7F, PRE (N=217;202) | 197 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-7F, M1 POST-BST (N=205;196) | 185 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-7F, M9 POST-BST (N=192;172) | 169 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-9V, PRE (N=213;188) | 159 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-9V, M1 POST-BST (N=200;189) | 157 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-9V, M9 POST-BST (N=194;168) | 148 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-14, PRE (N=205;192) | 73 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-14, M1 POST-BST (N=209;188) | 61 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-14, M9 POST-BST (N=185;159) | 57 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-18C, PRE (N=204;191) | 8 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-18C, M1 POST-BST (N=188;187) | 11 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-18C, M9 POST-BST (N=170;164) | 10 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19F, PRE (N=218;205) | 14 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19F, M1 POST-BST (N=199;200) | 13 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-19F, M9 POST-BST (N=194;170) | 11 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-23F, PRE (N=215;199) | 94 Subjects |
| Control Group | Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | OPSONO-23F, M1 POST-BST (N=206;190) | 97 Subjects |
Secondary
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.
Antibody concentrations were measured by 22F enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was \>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: At Month 5, one month after the third dose of primary vaccination
Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-1 (N=334;312) | 2.51 µg/mL |
| Synflorix Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-4 (N=334;328) | 3.26 µg/mL |
| Synflorix Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-5 (N=334;324) | 4.20 µg/mL |
| Synflorix Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANITI-6B (N=334;322) | 1.34 µg/mL |
| Synflorix Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-7F (N=334;330) | 3.86 µg/mL |
| Synflorix Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-9V (N=334;331) | 3.15 µg/mL |
| Synflorix Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-14 (N=334;330) | 4.55 µg/mL |
| Synflorix Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-18C (N=334;328) | 5.32 µg/mL |
| Synflorix Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-19F (N=334;327) | 5.33 µg/mL |
| Synflorix Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-23F (N=334;331) | 1.99 µg/mL |
| Control Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-18C (N=334;328) | 0.04 µg/mL |
| Control Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-1 (N=334;312) | 0.04 µg/mL |
| Control Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-9V (N=334;331) | 0.04 µg/mL |
| Control Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-4 (N=334;328) | 0.03 µg/mL |
| Control Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-23F (N=334;331) | 0.04 µg/mL |
| Control Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-5 (N=334;324) | 0.05 µg/mL |
| Control Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-14 (N=334;330) | 0.09 µg/mL |
| Control Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANITI-6B (N=334;322) | 0.03 µg/mL |
| Control Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-19F (N=334;327) | 0.06 µg/mL |
| Control Group | Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. | ANTI-7F (N=334;330) | 0.04 µg/mL |
Secondary
Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset
The cut-off of the assay was \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: At Month 5, one month after the third dose of primary vaccination
Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | OPSONO-6A (N=297;305) | 156.9 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | OPSONO-19A (N=302;309) | 18.2 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | OPSONO-6A (N=297;305) | 5.0 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | OPSONO-19A (N=302;309) | 4.1 Titers |
Secondary
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset
The cut-off of the assay was \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | OPSONO-6A, PRE (N=189;194) | 43.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | OPSONO-6A, M1 POST BST (N=185;185) | 277.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | OPSONO-6A, M9 POST-BST (N=175;156) | 63.9 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | OPSONO-19A, PRE (N=217;204) | 6.3 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | OPSONO-19A, M1 POST-BST (N=200;197) | 132.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | OPSONO-19A, M9 POST-BST (N=187;171) | 26.1 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | OPSONO-19A, M1 POST-BST (N=200;197) | 5.4 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | OPSONO-6A, PRE (N=189;194) | 7.1 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | OPSONO-19A, PRE (N=217;204) | 5.0 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | OPSONO-6A, M1 POST BST (N=185;185) | 7.6 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | OPSONO-19A, M9 POST-BST (N=187;171) | 6.3 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | OPSONO-6A, M9 POST-BST (N=175;156) | 17.2 Titers |
Secondary
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset
The cut-off of the assay was \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-9V, PRE (N=213;188) | 709.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-5, M9 POST-BST (N=192;173) | 44.1 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-9V, M1 POST-BST (N=200;189) | 3763.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-1, M1 POST-BST (N=209;200) | 357.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-9V, M9 POST-BST (N=194;168) | 1320.3 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-6B, PRE (N=209;197) | 95.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-14, PRE (N=205;192) | 121.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-4, M9 POST-BST (N=192;173) | 165.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-14, M1 POST-BST (N=209;188) | 2659.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-6B, M1 POST-BST (N=203;190) | 1123.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-14, M9 POST-BST (N=185;159) | 330.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-4, PRE (N=208;193) | 29.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-18C, PRE (N=204;191) | 15.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-6B, M9 POST-BST (N=178;165) | 128.9 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-18C, M1 POST-BST (N=188;187) | 2426.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-5, PRE (N=205;204) | 18.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-18C, M9 POST-BST (N=170;164) | 722.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-7F, PRE (N=217;202) | 1522.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-19F, PRE (N=218;205) | 24.3 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-1, M9 POST-BST (N=196;176) | 34.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-19F, M1 POST-BST (N=199;200) | 657.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-7F, M1 POST-BST (N=205;196) | 4336.3 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-19F, M9 POST-BST (N=194;170) | 118.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-5, M1 POST-BST (N=196;187) | 306.1 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-23F, PRE (N=215;199) | 679.3 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-7F, M9 POST-BST (N=192;172) | 2598.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-23F, M1 POST-BST (N=206;190) | 4278.3 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-4, M1 POST-BST (N=207;193) | 2853.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-23F, M9 POST-BST (N=187;167) | 999.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-1, PRE (N=221;210) | 9.0 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-23F, M9 POST-BST (N=187;167) | 109.4 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-1, PRE (N=221;210) | 4.6 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-1, M1 POST-BST (N=209;200) | 4.8 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-1, M9 POST-BST (N=196;176) | 4.6 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-4, PRE (N=208;193) | 8.6 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-4, M1 POST-BST (N=207;193) | 8.3 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-4, M9 POST-BST (N=192;173) | 8.1 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-5, PRE (N=205;204) | 4.3 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-5, M1 POST-BST (N=196;187) | 4.4 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-5, M9 POST-BST (N=192;173) | 4.2 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-6B, PRE (N=209;197) | 7.6 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-6B, M1 POST-BST (N=203;190) | 7.1 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-6B, M9 POST-BST (N=178;165) | 11.4 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-7F, PRE (N=217;202) | 979.5 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-7F, M1 POST-BST (N=205;196) | 746.4 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-7F, M9 POST-BST (N=192;172) | 1214.3 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-9V, PRE (N=213;188) | 233.7 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-9V, M1 POST-BST (N=200;189) | 250.9 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-9V, M9 POST-BST (N=194;168) | 337.4 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-14, PRE (N=205;192) | 27.0 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-14, M1 POST-BST (N=209;188) | 21.7 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-14, M9 POST-BST (N=185;159) | 27.6 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-18C, PRE (N=204;191) | 4.8 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-18C, M1 POST-BST (N=188;187) | 5.2 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-18C, M9 POST-BST (N=170;164) | 5.3 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-19F, PRE (N=218;205) | 5.0 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-19F, M1 POST-BST (N=199;200) | 5.0 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-19F, M9 POST-BST (N=194;170) | 4.8 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-23F, PRE (N=215;199) | 76.9 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-23F, M1 POST-BST (N=206;190) | 99.7 Titers |
Secondary
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset
The cut-off of the assay was \>= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Time frame: At Month 5, one month after the third dose of primary vaccination,
Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-1 (N=306;305) | 139.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-4 (N=310;299) | 771.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-5 (N=313;314) | 224.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-6B (N=315;309) | 689.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-7F (N=302;266) | 4656.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-9V (N=312;302) | 1690.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-14 (N=308;273) | 908.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-18C (N=308;317) | 310.9 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-19F (N=304;314) | 383.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-23F (N=317;282) | 2167.4 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-18C (N=308;317) | 4.4 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-1 (N=306;305) | 4.8 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-9V (N=312;302) | 14.6 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-4 (N=310;299) | 5.1 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-23F (N=317;282) | 14.5 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-5 (N=313;314) | 4.5 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-14 (N=308;273) | 16.5 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-6B (N=315;309) | 5.4 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-19F (N=304;314) | 4.7 Titers |
| Control Group | Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | OPSONO-7F (N=302;266) | 110.4 Titers |