Infections, Streptococcal
Conditions
Keywords
Immunogenicity, Safety, Pneumococcal vaccine, Pneumococcal disease
Brief summary
This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age. The study has 2 groups. * One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated). * The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™. All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol posting deals with objectives & outcome measures of the primary study. The objectives & outcome measures of the Booster study are presented in a separate protocol posting (NCT number =00547248).
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Interventions
3 Intramuscular injections.
BIOLOGICALPrevenar
3 Intramuscular injections
BIOLOGICALTritanrix-HepB
3 Intramuscular injections
BIOLOGICALHiberix
Reconstituted with Tritanrix before injection
BIOLOGICALPolio Sabin.
3 oral doses.
BIOLOGICALPoliorix.
3 intramuscular injections
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination. * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Born after a gestation period between 36 and 42 weeks.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3. * Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations * History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease. * Acute disease at the time of enrolment * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | Within 4 day (Days 0-3) after each dose and across doses | Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within 4-day (Days 0-3) after each dose and across doses | Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Related (REL) = Symptom assessed by the investigator as causally related to vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | Within 31 days (Days 0-30) after each vaccination | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Serious Adverse (SAEs) | During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | Seropositivity status, defined as Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL). |
| Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | Cut-off values assessed were greater than or equal to 0.2 microgram per milliliter (µg/mL) in the sera of subjects. |
| Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | Cut-off values assessed were greater than or equal to 0.05 microgram per liter (µg/mL) in the sera of subjects. |
| Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8 |
| Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F ≥ 8. |
| Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | Seropositivity status, defined as Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL). |
| Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | Cut-off values assessed were greater than or equal to 0.05 microgram per milliliter (μg/mL) in the sera of subjects seronegative before vaccination. |
| Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8 |
| Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8 |
| Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Within 4 day (Days 0-3) after each dose and across doses | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity. |
| Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL) | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | Cut-off values assessed were greater than or equal to 100 ELISA units per milliliter (EL.U/mL) in the sera of subjects. |
| Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL) | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | Cut-off values assessed were greater than or equal to 0.15 microgram per milliliter (µg/ mL) in the sera of subjects. |
| Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | Cut-off values assessed were greater than or equal to 1.0 microgram per milliliter (µg/mL) in the sera of subjects. |
| Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | Seroprotection status, defined as Anti-PRP antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL |
| Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | Cut-off values assessed were greater than or equal to 0.1 International Units per milliliter (IU/mL) in the sera of subjects. |
| Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | Seroprotection status, defined as Anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL |
| Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL) | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | Cut-off values assessed were greater than or equal to 10 milli-International Units per milliliter (mIU/mL) in the sera of subjects. |
| Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | Seroprotection status, defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL |
| Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | Titers were expressed as geometric mean titres (GMTs). |
| Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | Seroprotection status, defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8 |
| Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity) | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | Cut-off values assessed were greater than or equal to 15 ELISA unit per milli-liter (EL.U/mL) in the sera of subjects seronegative before vaccination. |
| Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | Seropositivity status, defined as Anti-BPT antibody concentrations ≥ 15 EL.U/mL. |
| Number of Subjects With Vaccine Response to Bordetella Pertussis | One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™ | Vaccine response to B. pertussis;defined as appearance of antibodies in subjects initially seronegative (S-) (i.e., concentrations \< 15 EL.U/mL) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e., with concentrations ≥ 15 EL.U/mL). |
| Concentrations of Antibodies Against Protein D (Anti-PD) | One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™ | Seropositivity status, defined as Anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL) |
Countries
Philippines, Poland
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Synflorix 1 Group Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. | 300 |
| Synflorix 2 Group Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. | 303 |
| Prevenar 1 Group Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. | 100 |
| Prevenar 2 Group Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age. | 103 |
| Total | 806 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 0 | 2 |
Baseline characteristics
| Characteristic | Synflorix 1 Group | Synflorix 2 Group | Prevenar 1 Group | Prevenar 2 Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 7.5 Weeks STANDARD_DEVIATION 1.64 | 7.4 Weeks STANDARD_DEVIATION 1.5 | 7.4 Weeks STANDARD_DEVIATION 1.53 | 7.5 Weeks STANDARD_DEVIATION 1.55 | 7.45 Weeks STANDARD_DEVIATION 1.56 |
| Sex: Female, Male Female | 146 Participants | 141 Participants | 48 Participants | 46 Participants | 381 Participants |
| Sex: Female, Male Male | 154 Participants | 162 Participants | 52 Participants | 57 Participants | 425 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 300 | 0 / 303 | 0 / 100 | 0 / 103 |
| other Total, other adverse events | 296 / 300 | 300 / 303 | 95 / 100 | 98 / 103 |
| serious Total, serious adverse events | 16 / 300 | 52 / 303 | 4 / 100 | 19 / 103 |
Outcome results
Primary
Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)
Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.
Time frame: Within 4 day (Days 0-3) after each dose and across doses
Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in. For reasons of safety analysis related to rectal temperature, subjects were pooled to form the Synflorix Pooled Group and Prevenar Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Pooled Group | Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | Fever > 39.0°C, post Dose 1 | 31 Participants |
| Synflorix Pooled Group | Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | Fever > 39.0°C, post Dose 2 | 30 Participants |
| Synflorix Pooled Group | Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | Fever > 39.0°C, post Dose 3 | 42 Participants |
| Synflorix Pooled Group | Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | Fever > 39.0°C, across doses | 88 Participants |
| Prevenar Pooled Group | Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | Fever > 39.0°C, across doses | 23 Participants |
| Prevenar Pooled Group | Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | Fever > 39.0°C, post Dose 1 | 6 Participants |
| Prevenar Pooled Group | Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | Fever > 39.0°C, post Dose 3 | 8 Participants |
| Prevenar Pooled Group | Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | Fever > 39.0°C, post Dose 2 | 13 Participants |
Comparison: Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.95% CI: [-1.51, 4.88]
Comparison: Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.95% CI: [-6.05, 1.92]
Comparison: Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.95% CI: [-1.02, 6.19]
Comparison: Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.95% CI: [-2.65, 8.01]
Secondary
Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations
Seropositivity status, defined as Anti-BPT antibody concentrations ≥ 15 EL.U/mL.
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix Pooled Group | Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations | 72.465 EL.U/mL |
| Prevenar Pooled Group | Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations | 53.481 EL.U/mL |
| Prevenar 1 Group | Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations | 77.175 EL.U/mL |
| Prevenar 2 Group | Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations | 60.003 EL.U/mL |
Secondary
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Seroprotection status, defined as Anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Pooled Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-diphtheria | 1.735 IU/mL |
| Synflorix Pooled Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-tetanus | 5.195 IU/mL |
| Prevenar Pooled Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-tetanus | 3.505 IU/mL |
| Prevenar Pooled Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-diphtheria | 1.549 IU/mL |
| Prevenar 1 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-diphtheria | 1.252 IU/mL |
| Prevenar 1 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-tetanus | 3.476 IU/mL |
| Prevenar 2 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-diphtheria | 1.039 IU/mL |
| Prevenar 2 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-tetanus | 2.659 IU/mL |
Secondary
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Seroprotection status, defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix Pooled Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | 101.6 mIU/mL |
| Prevenar Pooled Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | 756.7 mIU/mL |
| Prevenar 1 Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | 129.8 mIU/mL |
| Prevenar 2 Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | 792.2 mIU/mL |
Secondary
Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers
Seroprotection status, defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Pooled Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-polio 1 | 641.5 Titers |
| Synflorix Pooled Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-polio 3 | 204.5 Titers |
| Synflorix Pooled Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-polio 2 | 523.6 Titers |
| Prevenar Pooled Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-polio 1 | 331.1 Titers |
| Prevenar Pooled Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-polio 3 | 540.8 Titers |
| Prevenar Pooled Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-polio 2 | 276.8 Titers |
| Prevenar 1 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-polio 2 | 546.2 Titers |
| Prevenar 1 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-polio 1 | 373.7 Titers |
| Prevenar 1 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-polio 3 | 101.9 Titers |
| Prevenar 2 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-polio 1 | 267.6 Titers |
| Prevenar 2 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-polio 3 | 611.5 Titers |
| Prevenar 2 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-polio 2 | 303.5 Titers |
Secondary
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations
Seroprotection status, defined as Anti-PRP antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix Pooled Group | Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations | 26.001 μg/mL |
| Prevenar Pooled Group | Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations | 9.376 μg/mL |
| Prevenar 1 Group | Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations | 25.758 μg/mL |
| Prevenar 2 Group | Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations | 8.86 μg/mL |
Secondary
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Seropositivity status, defined as Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Pooled Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-6A | 0.3 μg/mL |
| Synflorix Pooled Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-19A | 0.36 μg/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-19A | 0.29 μg/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-6A | 0.17 μg/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-6A | 0.23 μg/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-19A | 0.18 μg/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-6A | 0.26 μg/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-19A | 0.12 μg/mL |
Secondary
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Seropositivity status, defined as Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-7F POST | 4.84 μg/mL |
| Synflorix Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-9V POST | 4.04 μg/mL |
| Synflorix Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-14 POST | 6.45 μg/mL |
| Synflorix Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-4 POST | 4.96 μg/mL |
| Synflorix Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-23F POST | 2.23 μg/mL |
| Synflorix Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-19F POST | 10.46 μg/mL |
| Synflorix Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-5 POST | 4.87 μg/mL |
| Synflorix Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-1 POST | 3.23 μg/mL |
| Synflorix Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-6B POST | 1.19 μg/mL |
| Synflorix Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-18C POST | 11.56 μg/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-7F POST | 2.25 μg/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-23F POST | 1.11 μg/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-14 POST | 3.31 μg/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-6B POST | 0.73 μg/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-9V POST | 1.51 μg/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-19F POST | 5.3 μg/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-5 POST | 1.62 μg/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-1 POST | 1.04 μg/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-4 POST | 1.64 μg/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-18C POST | 3.74 μg/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-19F POST | 4.68 μg/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-1 POST | 0.03 μg/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-4 POST | 5.68 μg/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-5 POST | 0.03 μg/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-6B POST | 1.06 μg/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-7F POST | 0.05 μg/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-9V POST | 5.07 μg/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-14 POST | 5.88 μg/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-18C POST | 3.71 μg/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-23F POST | 2.28 μg/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-14 POST | 5.23 μg/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-6B POST | 1.23 μg/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-5 POST | 0.03 μg/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-23F POST | 2.2 μg/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-18C POST | 2.64 μg/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-4 POST | 2.14 μg/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-1 POST | 0.03 μg/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-9V POST | 2.7 μg/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-7F POST | 0.04 μg/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-19F POST | 2.38 μg/mL |
Secondary
Concentrations of Antibodies Against Protein D (Anti-PD)
Seropositivity status, defined as Anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL)
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix Pooled Group | Concentrations of Antibodies Against Protein D (Anti-PD) | 3800 EL.U/mL |
| Prevenar Pooled Group | Concentrations of Antibodies Against Protein D (Anti-PD) | 2002 EL.U/mL |
| Prevenar 1 Group | Concentrations of Antibodies Against Protein D (Anti-PD) | 105.2 EL.U/mL |
| Prevenar 2 Group | Concentrations of Antibodies Against Protein D (Anti-PD) | 66.6 EL.U/mL |
Secondary
Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity)
Cut-off values assessed were greater than or equal to 15 ELISA unit per milli-liter (EL.U/mL) in the sera of subjects seronegative before vaccination.
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity) | 137 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity) | 126 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity) | 47 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity) | 42 Participants |
Secondary
Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL)
Cut-off values assessed were greater than or equal to 0.1 International Units per milliliter (IU/mL) in the sera of subjects.
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | Anti-diphtheria | 137 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | Anti-tetanus | 139 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | Anti-tetanus | 140 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | Anti-diphtheria | 140 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | Anti-diphtheria | 49 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | Anti-tetanus | 48 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | Anti-diphtheria | 46 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | Anti-tetanus | 47 Participants |
Secondary
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL)
Cut-off values assessed were greater than or equal to 10 milli-International Units per milliliter (mIU/mL) in the sera of subjects.
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL) | 127 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL) | 132 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL) | 44 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL) | 44 Participants |
Secondary
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL)
Cut-off values assessed were greater than or equal to 0.05 microgram per liter (µg/mL) in the sera of subjects.
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-5 POST | 285 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-9V POST | 285 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-1 POST | 285 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-14 POST | 285 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-6B POST | 279 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-18C POST | 284 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-4 POST | 285 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-19F POST | 285 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-7F POST | 285 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-23F POST | 285 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-7F POST | 285 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-9V POST | 285 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-14 POST | 285 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-4 POST | 285 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-1 POST | 285 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-5 POST | 285 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-19F POST | 285 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-6B POST | 274 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-23F POST | 279 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-18C POST | 285 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-7F POST | 37 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-18C POST | 95 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-1 POST | 20 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-4 POST | 95 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-5 POST | 19 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-6B POST | 92 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-9V POST | 95 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-14 POST | 95 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-19F POST | 95 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-23F POST | 91 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-7F POST | 22 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-18C POST | 95 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-6B POST | 91 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-5 POST | 13 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-23F POST | 96 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-19F POST | 95 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-4 POST | 96 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-9V POST | 96 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-1 POST | 13 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) | Anti-14 POST | 96 Participants |
Secondary
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL)
Cut-off values assessed were greater than or equal to 0.2 microgram per milliliter (µg/mL) in the sera of subjects.
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-9V POST | 284 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-5 POST | 285 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-19F POST | 285 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-1 POST | 285 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-7F POST | 284 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-6B POST | 260 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-18C POST | 284 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-4 POST | 283 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-23F POST | 277 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-14 POST | 285 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-7F POST | 285 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-1 POST | 280 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-9V POST | 285 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-18C POST | 281 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-4 POST | 282 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-5 POST | 282 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-6B POST | 244 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-14 POST | 285 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-19F POST | 282 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-23F POST | 269 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-4 POST | 95 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-9V POST | 95 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-1 POST | 3 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-23F POST | 90 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-19F POST | 94 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-14 POST | 95 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-18C POST | 95 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-6B POST | 82 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-7F POST | 9 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-5 POST | 3 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-5 POST | 2 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-7F POST | 5 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-4 POST | 96 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-9V POST | 96 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-23F POST | 95 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-14 POST | 96 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-1 POST | 3 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-18C POST | 95 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-19F POST | 95 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) | Anti-6B POST | 91 Participants |
Secondary
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8
Titers were expressed as geometric mean titres (GMTs).
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Anti-polio 1 | 120 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Anti-polio 3 | 116 Participants |
| Synflorix Pooled Group | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Anti-polio 2 | 124 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Anti-polio 1 | 120 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Anti-polio 3 | 107 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Anti-polio 2 | 115 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Anti-polio 2 | 43 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Anti-polio 1 | 40 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Anti-polio 3 | 32 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Anti-polio 1 | 40 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Anti-polio 3 | 39 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 | Anti-polio 2 | 41 Participants |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL)
Cut-off values assessed were greater than or equal to 0.15 microgram per milliliter (µg/ mL) in the sera of subjects.
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL) | 140 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL) | 140 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL) | 49 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL) | 47 Participants |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)
Cut-off values assessed were greater than or equal to 1.0 microgram per milliliter (µg/mL) in the sera of subjects.
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | 139 Participants |
| Prevenar Pooled Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | 137 Participants |
| Prevenar 1 Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | 48 Participants |
| Prevenar 2 Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | 45 Participants |
Secondary
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity.
Time frame: Within 4 day (Days 0-3) after each dose and across doses
Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Post Dose 1 | 126 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Post Dose 1 | 240 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Post Dose 1 | 52 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Post Dose 1 | 10 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Post Dose 1 | 142 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Post Dose 1 | 41 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Post Dose 2 | 191 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Post Dose 2 | 18 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Post Dose 2 | 135 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Post Dose 2 | 8 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Post Dose 2 | 98 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Post Dose 2 | 27 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Post Dose 3 | 168 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Post Dose 3 | 14 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Post Dose 3 | 158 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Post Dose 3 | 3 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Post Dose 3 | 84 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Post Dose 3 | 15 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 258 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 64 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 221 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 18 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 174 Participants |
| Synflorix Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 57 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 65 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Post Dose 3 | 173 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 83 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 226 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 42 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Post Dose 3 | 23 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Post Dose 2 | 204 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Post Dose 3 | 151 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Post Dose 2 | 186 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Post Dose 3 | 209 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Post Dose 1 | 59 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Post Dose 3 | 8 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 255 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Post Dose 2 | 9 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Post Dose 2 | 31 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Post Dose 1 | 206 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 265 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Post Dose 2 | 163 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Post Dose 1 | 153 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Post Dose 1 | 43 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Post Dose 1 | 199 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Post Dose 2 | 19 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Post Dose 1 | 30 Participants |
| Prevenar Pooled Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Post Dose 3 | 19 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 82 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Post Dose 2 | 55 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 22 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Post Dose 2 | 8 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Post Dose 2 | 44 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Post Dose 2 | 1 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Post Dose 2 | 29 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Post Dose 2 | 5 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Post Dose 3 | 44 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Post Dose 3 | 1 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 6 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Post Dose 3 | 45 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Post Dose 3 | 0 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 16 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 67 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Post Dose 3 | 25 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Post Dose 3 | 4 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Post Dose 1 | 15 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 42 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Post Dose 1 | 76 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Post Dose 1 | 19 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Post Dose 1 | 35 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Post Dose 1 | 6 Participants |
| Prevenar 1 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Post Dose 1 | 39 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Post Dose 3 | 10 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 90 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Post Dose 2 | 51 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Post Dose 1 | 8 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 89 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Post Dose 2 | 2 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Post Dose 2 | 61 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Post Dose 1 | 65 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 16 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Post Dose 2 | 59 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Post Dose 1 | 9 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Post Dose 1 | 17 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 12 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Post Dose 3 | 70 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Post Dose 1 | 56 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Redness, Post Dose 3 | 4 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Redness, Post Dose 1 | 65 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Post Dose 3 | 8 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 25 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Pain, Post Dose 2 | 12 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Post Dose 3 | 53 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Pain, Post Dose 3 | 56 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Post Dose 2 | 5 Participants |
| Prevenar 2 Group | Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 75 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Related (REL) = Symptom assessed by the investigator as causally related to vaccination.
Time frame: Within 4-day (Days 0-3) after each dose and across doses
Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Dose 2 | 0 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Dose 3 | 61 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Dose 2 | 66 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 214 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 90 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Dose 3 | 2 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Dose 3 | 1 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness, Dose 3 | 90 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Dose 1 | 236 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 147 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Across Doses | 22 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 61 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Dose 3 | 0 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Dose 1 | 0 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Dose 3 | 147 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Dose 3 | 169 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 169 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Dose 3 | 7 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Dose 1 | 214 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Dose 1 | 1 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 258 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 236 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Across | 1 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Dose 1 | 11 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 104 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across | 140 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Across Doses | 255 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 154 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Dose 1 | 104 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Across Doses | 0 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 102 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 182 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Dose 2 | 1 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 255 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness, Dose 2 | 102 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Dose 1 | 6 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness, Across Doses | 184 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Dose 2 | 0 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Dose 2 | 182 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 185 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Across Doses | 9 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Across Doses | 258 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Dose 2 | 8 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness Dose 1 | 154 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Dose 2 | 185 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 184 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 66 Participants |
| Synflorix Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Across | 140 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Dose 2 | 37 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Across Doses | 89 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 166 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Dose 3 | 113 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Dose 2 | 116 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Dose 2 | 0 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Dose 3 | 1 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Dose 1 | 1 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 152 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Dose 1 | 10 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Dose 3 | 5 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 190 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Across Doses | 0 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Across Doses | 17 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness, Dose 3 | 151 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Dose 1 | 165 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 113 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 223 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 163 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 256 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Dose 2 | 184 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 172 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Dose 3 | 0 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 117 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Dose 3 | 223 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 261 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Dose 3 | 162 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Dose 1 | 0 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Dose 2 | 237 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Dose 2 | 9 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 225 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Dose 3 | 22 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 238 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Across | 2 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 289 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness Dose 1 | 222 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness, Dose 2 | 172 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Across Doses | 289 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness, Across Doses | 256 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 269 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 184 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Dose 2 | 0 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Dose 1 | 60 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Across | 220 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Dose 1 | 190 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Dose 1 | 266 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across | 221 Participants |
| Prevenar Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Across Doses | 261 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Across Doses | 88 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Dose 2 | 1 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 25 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 43 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Across Doses | 3 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 45 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Dose 1 | 3 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness Dose 1 | 45 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 74 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Dose 1 | 0 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Dose 1 | 74 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 78 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Dose 1 | 3 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Dose 1 | 78 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 26 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Dose 1 | 1 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Dose 1 | 26 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 25 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness, Dose 2 | 24 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 63 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Dose 2 | 0 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Dose 2 | 63 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 49 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Dose 2 | 3 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Dose 2 | 48 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 20 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Dose 2 | 0 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Dose 2 | 19 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Dose 3 | 0 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness, Dose 3 | 25 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 50 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Dose 3 | 0 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Dose 3 | 50 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Dose 3 | 1 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Dose 3 | 43 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 19 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Dose 3 | 0 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Dose 3 | 19 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 56 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness, Across Doses | 56 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 88 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Across Doses | 0 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 82 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Across Doses | 6 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Across Doses | 82 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across | 39 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Across | 1 Participants |
| Prevenar 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Across | 39 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 28 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Across Doses | 3 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Dose 3 | 19 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Dose 2 | 72 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Dose 2 | 9 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 83 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 85 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Dose 2 | 50 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Dose 2 | 0 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 51 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness, Dose 2 | 56 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across | 64 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness, Across Doses | 85 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Dose 2 | 2 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 57 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 19 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 77 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Dose 1 | 51 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Dose 1 | 1 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 41 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Across Doses | 1 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 52 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Dose 1 | 83 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Dose 1 | 17 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Across Doses | 77 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Dose 1 | 54 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Dose 1 | 0 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Across | 63 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 93 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 54 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness Dose 1 | 75 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Across | 1 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Across Doses | 24 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 64 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Dose 1 | 1 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Irritability, Dose 3 | 2 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Fever, Dose 3 | 49 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Fever, Dose 3 | 1 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 75 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Dose 3 | 64 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 49 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Drowsiness, Dose 3 | 40 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 73 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Drowsiness, Dose 3 | 0 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Loss of appetite, Dose 2 | 27 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | REL Irritability, Across Doses | 93 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Dose 3 | 0 Participants |
| Prevenar 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | G3 Loss of appetite, Dose 2 | 0 Participants |
Secondary
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL)
Cut-off values assessed were greater than or equal to 0.05 microgram per milliliter (μg/mL) in the sera of subjects seronegative before vaccination.
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) | Anti-6A | 261 Participants |
| Synflorix Pooled Group | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) | Anti-19A | 169 Participants |
| Prevenar Pooled Group | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) | Anti-19A | 164 Participants |
| Prevenar Pooled Group | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) | Anti-6A | 230 Participants |
| Prevenar 1 Group | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) | Anti-6A | 84 Participants |
| Prevenar 1 Group | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) | Anti-19A | 90 Participants |
| Prevenar 2 Group | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) | Anti-6A | 84 Participants |
| Prevenar 2 Group | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) | Anti-19A | 83 Participants |
Secondary
Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL)
Cut-off values assessed were greater than or equal to 100 ELISA units per milliliter (EL.U/mL) in the sera of subjects.
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL) | 284 Participants |
| Prevenar Pooled Group | Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL) | 285 Participants |
| Prevenar 1 Group | Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL) | 39 Participants |
| Prevenar 2 Group | Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL) | 18 Participants |
Secondary
Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 | OPA Anti-19A | 35 Participants |
| Synflorix Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 | OPA Anti-6A | 91 Participants |
| Prevenar Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 | OPA Anti-6A | 83 Participants |
| Prevenar Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 | OPA Anti-19A | 41 Participants |
| Prevenar 1 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 | OPA Anti-6A | 34 Participants |
| Prevenar 1 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 | OPA Anti-19A | 1 Participants |
| Prevenar 2 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 | OPA Anti-19A | 0 Participants |
| Prevenar 2 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 | OPA Anti-6A | 36 Participants |
Secondary
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F ≥ 8.
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-1 | 117 Participants |
| Synflorix Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-4 | 137 Participants |
| Synflorix Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-5 | 139 Participants |
| Synflorix Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-6B | 132 Participants |
| Synflorix Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-7F | 137 Participants |
| Synflorix Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-9V | 130 Participants |
| Synflorix Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-14 | 138 Participants |
| Synflorix Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-18C | 138 Participants |
| Synflorix Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-19F | 137 Participants |
| Synflorix Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-23F | 141 Participants |
| Prevenar Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-5 | 127 Participants |
| Prevenar Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-19F | 142 Participants |
| Prevenar Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-6B | 122 Participants |
| Prevenar Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-7F | 141 Participants |
| Prevenar Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-9V | 144 Participants |
| Prevenar Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-14 | 142 Participants |
| Prevenar Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-23F | 132 Participants |
| Prevenar Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-18C | 137 Participants |
| Prevenar Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-1 | 62 Participants |
| Prevenar Pooled Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-4 | 143 Participants |
| Prevenar 1 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-18C | 45 Participants |
| Prevenar 1 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-14 | 43 Participants |
| Prevenar 1 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-23F | 42 Participants |
| Prevenar 1 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-1 | 1 Participants |
| Prevenar 1 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-6B | 40 Participants |
| Prevenar 1 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-9V | 43 Participants |
| Prevenar 1 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-19F | 42 Participants |
| Prevenar 1 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-4 | 43 Participants |
| Prevenar 1 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-7F | 10 Participants |
| Prevenar 1 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-5 | 0 Participants |
| Prevenar 2 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-7F | 5 Participants |
| Prevenar 2 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-18C | 48 Participants |
| Prevenar 2 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-9V | 49 Participants |
| Prevenar 2 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-23F | 49 Participants |
| Prevenar 2 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-14 | 48 Participants |
| Prevenar 2 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-4 | 49 Participants |
| Prevenar 2 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-5 | 0 Participants |
| Prevenar 2 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-6B | 44 Participants |
| Prevenar 2 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-1 | 0 Participants |
| Prevenar 2 Group | Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 | OPA Anti-19F | 45 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group
Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |
| Prevenar Pooled Group | Number of Subjects With Serious Adverse Events (SAEs) | 34 Participants |
| Prevenar 1 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Prevenar 2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 9 Participants |
Secondary
Number of Subjects With Serious Adverse (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group
Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Serious Adverse (SAEs) | 16 Participants |
| Prevenar Pooled Group | Number of Subjects With Serious Adverse (SAEs) | 52 Participants |
| Prevenar 1 Group | Number of Subjects With Serious Adverse (SAEs) | 4 Participants |
| Prevenar 2 Group | Number of Subjects With Serious Adverse (SAEs) | 19 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Time frame: Within 31 days (Days 0-30) after each vaccination
Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 168 Participants |
| Prevenar Pooled Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 166 Participants |
| Prevenar 1 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 46 Participants |
| Prevenar 2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 61 Participants |
Secondary
Number of Subjects With Vaccine Response to Bordetella Pertussis
Vaccine response to B. pertussis;defined as appearance of antibodies in subjects initially seronegative (S-) (i.e., concentrations \< 15 EL.U/mL) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e., with concentrations ≥ 15 EL.U/mL).
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Pooled Group | Number of Subjects With Vaccine Response to Bordetella Pertussis | S- | 127 Participants |
| Synflorix Pooled Group | Number of Subjects With Vaccine Response to Bordetella Pertussis | S+ | 9 Participants |
| Prevenar Pooled Group | Number of Subjects With Vaccine Response to Bordetella Pertussis | S+ | 12 Participants |
| Prevenar Pooled Group | Number of Subjects With Vaccine Response to Bordetella Pertussis | S- | 112 Participants |
| Prevenar 1 Group | Number of Subjects With Vaccine Response to Bordetella Pertussis | S- | 46 Participants |
| Prevenar 1 Group | Number of Subjects With Vaccine Response to Bordetella Pertussis | S+ | 1 Participants |
| Prevenar 2 Group | Number of Subjects With Vaccine Response to Bordetella Pertussis | S- | 38 Participants |
| Prevenar 2 Group | Number of Subjects With Vaccine Response to Bordetella Pertussis | S+ | 2 Participants |
Secondary
Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Pooled Group | Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A | OPA Anti-6A | 93.1 Titers |
| Synflorix Pooled Group | Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A | OPA Anti-19A | 10.6 Titers |
| Prevenar Pooled Group | Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A | OPA Anti-19A | 10.1 Titers |
| Prevenar Pooled Group | Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A | OPA Anti-6A | 60.5 Titers |
| Prevenar 1 Group | Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A | OPA Anti-6A | 137.3 Titers |
| Prevenar 1 Group | Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A | OPA Anti-19A | 4.2 Titers |
| Prevenar 2 Group | Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A | OPA Anti-6A | 175.1 Titers |
| Prevenar 2 Group | Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A | OPA Anti-19A | 4 Titers |
Secondary
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-1 | 93.7 Titers |
| Synflorix Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-4 | 1008.7 Titers |
| Synflorix Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-5 | 209.3 Titers |
| Synflorix Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-6B | 963.5 Titers |
| Synflorix Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-7F | 5196.4 Titers |
| Synflorix Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-9V | 1631.9 Titers |
| Synflorix Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-14 | 1669.1 Titers |
| Synflorix Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-18C | 673.3 Titers |
| Synflorix Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-19F | 1121.7 Titers |
| Synflorix Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-23F | 2186.6 Titers |
| Prevenar Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-5 | 67.2 Titers |
| Prevenar Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-19F | 337.8 Titers |
| Prevenar Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-6B | 361.9 Titers |
| Prevenar Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-7F | 2002.2 Titers |
| Prevenar Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-9V | 1171.7 Titers |
| Prevenar Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-14 | 640 Titers |
| Prevenar Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-23F | 920.6 Titers |
| Prevenar Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-18C | 174.9 Titers |
| Prevenar Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-1 | 14.8 Titers |
| Prevenar Pooled Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-4 | 602.9 Titers |
| Prevenar 1 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-18C | 283.7 Titers |
| Prevenar 1 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-14 | 2117.4 Titers |
| Prevenar 1 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-23F | 4126.6 Titers |
| Prevenar 1 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-1 | 4.2 Titers |
| Prevenar 1 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-6B | 1762.2 Titers |
| Prevenar 1 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-9V | 1713.3 Titers |
| Prevenar 1 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-19F | 81.6 Titers |
| Prevenar 1 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-4 | 1229.9 Titers |
| Prevenar 1 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-7F | 14.2 Titers |
| Prevenar 1 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-5 | 4 Titers |
| Prevenar 2 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-7F | 6.9 Titers |
| Prevenar 2 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-18C | 127 Titers |
| Prevenar 2 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-9V | 1166 Titers |
| Prevenar 2 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-23F | 3895.4 Titers |
| Prevenar 2 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-14 | 947.6 Titers |
| Prevenar 2 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-4 | 513 Titers |
| Prevenar 2 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-5 | 4 Titers |
| Prevenar 2 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-6B | 805 Titers |
| Prevenar 2 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-1 | 4 Titers |
| Prevenar 2 Group | Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA Anti-19F | 35.9 Titers |