Infections, Streptococcal
Conditions
Keywords
Pneumococcal vaccine, Preterm, Safety, Pneumococcal disease, Immunogenicity
Brief summary
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life. 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 = 00609492)
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
Intramuscular injection, 3 doses
BIOLOGICALInfanrix hexa
Intramuscular injection, 3 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Weeks to 16 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol * A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Born after a gestation period of \>27 weeks (at least 189 days). * If full term born, healthy subjects as established by medical history and clinical examination before entering into the study * If premature, medically stable condition (not requiring significant medical support or ongoing management for debilitating disease and having demonstrated a clinical course of sustained recovery).
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose. * Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month before the first dose of vaccines and up to Visit 6. * Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus 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, Haemophilus influenzae type b disease, Neisseria meningitidis. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of any neurologic disorders or seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past). * Acute disease at the time of enrolment. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within one month preceding the first dose of study vaccines or planned administration during the active phase of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4) | Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited General Symptoms | Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4) | Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Any was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. |
| Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off | One month after the 3rd vaccine dose (Month 5) | The cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL). |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 31 days (Days 0-30) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4) | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. |
| Number of Subjects With Any Serious Adverse Events (SAEs) | Throughout the active phase of the study (from the first vaccine administration (Month 0) up to 1 month after the third vaccine administration (Month5). | Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity. |
| Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | One month after the 3rd vaccine dose (Month 5) | The cut-off for the assay was ≥ 0.20 microgram per mililiter (μg/ mL). |
| Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | One month after the 3rd vaccine dose (Month 5) | The cut-off for the assay was ≥ 0.05 microgram per mililiter (μg/mL). |
| Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | One month after the 3rd vaccine dose (Month 5) | 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 Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | One month after the 3rd vaccine dose (Month 5) | The cut-off for the assay was ≥ 8 |
| Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | One month after the 3rd vaccine dose (Month 5) | 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 Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | One month after the 3rd vaccine dose (Month 5) | The cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL). |
| Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | One month after the 3rd vaccine dose (Month 5) | Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL). |
| Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | One month after the 3rd vaccine dose (Month 5) | The cut-off for the assay was ≥ 8. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4) | Solicited local symptoms assessed included 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 greater than (\>) 30 millimeters (mm). Any was defined as incidence of the specified symptom regardless of intensity. |
| Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) ≥ the Cut-off | One month after the 3rd vaccine dose (Month 5) | The cut-off for the assay was ≥ 100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). |
| Concentrations of Antibodies Against Protein D (Anti-PD) | One month after the 3rd vaccine dose (Month 5) | Seropositivity status was defined as anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL). |
| Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off | One month after the 3rd vaccine dose (Month 5) | Seroprotection status was defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL |
| Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off | One month after the 3rd vaccine dose (Month 5) | The cut-off for the assay was ≥ 0.15 microgram per milliliter (μg/mL). |
| Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations ≥ th Cut-off | One month after the 3rd vaccine dose (Month 5) | Seroprotection status was defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL |
| Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off | One month after the 3rd vaccine dose (Month 5) | The cut-off for the assay was ≥ 5 ELISA unit per milliliter (EL.U/mL). |
| Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | One month after the 3rd vaccine dose (Month 5) | Seropositivity status was defined as anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ 5 EL.U/mL. |
| Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off. | One month after the 3rd vaccine dose (Month 5) | The cut-off for the assay was ≥ 10 milli-international units per milliliter (mIU/mL). |
| Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | One month after the 3rd vaccine dose (Month 5) | Seroprotection status was defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL |
| Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres | One month after the 3rd vaccine dose (Month 5) | The cut-off for the assay was ≥ 8. |
| Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off | One month after the 3rd vaccine dose (Month 5) | Seroprotection status was defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8. |
| Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | One month after the 3rd vaccine dose (Month 5) | Vaccine response to PT, FHA and PRN was defined as appearance of antibodies in subjects who are initially seronegative (S-), or at least maintenance of pre-vaccination antibody concentrations in those who are initially seropositive (S+). For the SYNFLORIX™ + INFANRIX™ HEXA GROUP I, no subjects presented initial seropositivity for PT and PRN antigens. |
| Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | One month after the 3rd vaccine dose (Month 5) | Seropositivity status was defined as opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8. |
Countries
Greece, Spain
Participant flow
Recruitment details
For each subject the study duration was approximately 5 months for the active phase (Month 0 untill one month after last vaccination) and 10 months, including the 5 months extended safety follow-up.
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™ + Infanrix™ Hexa Group I Very preterm infants born after a gestation period of 27-30 weeks (189-216 days) | 50 |
| Synflorix™ + Infanrix™ Hexa Group II Mild preterm infants born after a gestation period of 31-36 weeks (217-258 days) | 87 |
| Synflorix™ + Infanrix™ Hexa Group III Infants born after a full-term gestation period of more than 36 weeks (more than 258 days) | 149 |
| Total | 286 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 5 |
| Overall Study | Migrated/moved from study area | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 2 |
Baseline characteristics
| Characteristic | Synflorix™ + Infanrix™ Hexa Group I | Synflorix™ + Infanrix™ Hexa Group II | Synflorix™ + Infanrix™ Hexa Group III | Total |
|---|---|---|---|---|
| Age, Continuous | 11.0 Weeks STANDARD_DEVIATION 3.2 | 9.5 Weeks STANDARD_DEVIATION 1.45 | 9.3 Weeks STANDARD_DEVIATION 1.45 | 9.66 Weeks STANDARD_DEVIATION 1.97 |
| Race/Ethnicity, Customized Race/Etnicity African heritage/ African american | 2 Participants | 1 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Race/Etnicity American Indian or Alaskan native | 4 Participants | 6 Participants | 2 Participants | 12 Participants |
| Race/Ethnicity, Customized Race/Etnicity Asian - south east Asian heritage | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Etnicity Other (unspecified) | 7 Participants | 2 Participants | 1 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Etnicity White - Arabic/ north African heritage | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Etnicity White - Caucasian/ European heritage | 36 Participants | 77 Participants | 140 Participants | 253 Participants |
| Sex: Female, Male Female | 19 Participants | 40 Participants | 62 Participants | 121 Participants |
| Sex: Female, Male Male | 31 Participants | 47 Participants | 87 Participants | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 50 | 0 / 87 | 0 / 149 |
| other Total, other adverse events | 42 / 50 | 76 / 87 | 136 / 149 |
| serious Total, serious adverse events | 17 / 50 | 11 / 87 | 19 / 149 |
Outcome results
Primary
Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off
Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine.
Time frame: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants Pooled Group I + II) and Full term group (i.e. Synflorix™ + Infanrix™ Hexa Group III).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Fever > 39.0°C, post Dose 1 | 5 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Fever > 39.0°C, post Dose 2 | 1 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Fever > 39.0°C, post Dose 3 | 3 Participants |
| Pooled Group I + II | Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Fever > 39.0°C, post Dose 1 | 2 Participants |
| Pooled Group I + II | Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Fever > 39.0°C, post Dose 2 | 1 Participants |
| Pooled Group I + II | Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Fever > 39.0°C, post Dose 3 | 1 Participants |
Secondary
Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Seropositivity status was defined as anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA | 188.6 EL.U/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT | 41.9 EL.U/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN | 127.6 EL.U/mL |
| Pooled Group I + II | Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA | 169 EL.U/mL |
| Pooled Group I + II | Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT | 37.9 EL.U/mL |
| Pooled Group I + II | Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN | 109.1 EL.U/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT | 47.3 EL.U/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN | 119.1 EL.U/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA | 163.1 EL.U/mL |
Secondary
Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off
Seroprotection status was defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off | Anti-diphtheria | 2.495 IU/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off | Anti-tetanus | 7.745 IU/mL |
| Pooled Group I + II | Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off | Anti-diphtheria | 3.23 IU/mL |
| Pooled Group I + II | Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off | Anti-tetanus | 8.617 IU/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off | Anti-diphtheria | 3.077 IU/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off | Anti-tetanus | 7.695 IU/mL |
Secondary
Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off
Seroprotection status was defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8.
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off | Anti-Polio 3 | 248.4 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off | Anti-Polio 2 | 341.7 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off | Anti-Polio 1 | 271.3 Titers |
| Pooled Group I + II | Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off | Anti-Polio 2 | 319 Titers |
| Pooled Group I + II | Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off | Anti-Polio 1 | 189.5 Titers |
| Pooled Group I + II | Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off | Anti-Polio 3 | 344.7 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off | Anti-Polio 1 | 230.1 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off | Anti-Polio 3 | 384.8 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off | Anti-Polio 2 | 194.4 Titers |
Secondary
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Seroprotection status was defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | 431.9 mIU/mL |
| Pooled Group I + II | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | 356 mIU/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | 462.9 mIU/mL |
Secondary
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations ≥ th Cut-off
Seroprotection status was defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations ≥ th Cut-off | 4.031 μg/mL |
| Pooled Group I + II | Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations ≥ th Cut-off | 5.804 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations ≥ th Cut-off | 7.952 μg/mL |
Secondary
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Seropositivity status was 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 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-6A | 0.14 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-19A | 0.08 μg/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-6A | 0.21 μg/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-19A | 0.21 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-6A | 0.2 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-19A | 0.26 μg/mL |
Secondary
Concentrations of Antibodies Against Protein D (Anti-PD)
Seropositivity status was defined as anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL).
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Protein D (Anti-PD) | 1688.6 EL.U/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Protein D (Anti-PD) | 1415.4 EL.U/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Protein D (Anti-PD) | 1496.8 EL.U/mL |
Secondary
Concentrations of Antibodies Against Vaccine 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 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-14 | 3.52 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-4 | 1.53 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-18C | 3.28 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-19F | 3.6 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-23F | 1.05 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-5 | 1.45 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-1 | 0.97 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-6B | 0.85 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-7F | 1.87 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-9V | 1.43 μg/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-1 | 1.1 μg/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-5 | 1.93 μg/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-14 | 3.28 μg/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-18C | 4.86 μg/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-4 | 1.88 μg/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-7F | 2.37 μg/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-19F | 4.8 μg/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-9V | 1.69 μg/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-23F | 1.33 μg/mL |
| Pooled Group I + II | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-6B | 1.11 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-23F | 1.54 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-1 | 1.35 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-4 | 2.42 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-5 | 2.31 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-6B | 1.18 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-9V | 2.41 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-14 | 3.71 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-18C | 5.22 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-19F | 4.56 μg/mL |
| Synflorix™ + Infanrix™ Hexa Group III | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-7F | 2.69 μg/mL |
Secondary
Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off
The cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off | Anti-diphtheria | 18 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off | Anti-tetanus | 18 Participants |
| Pooled Group I + II | Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off | Anti-diphtheria | 41 Participants |
| Pooled Group I + II | Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off | Anti-tetanus | 41 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off | Anti-diphtheria | 61 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off | Anti-tetanus | 61 Participants |
Secondary
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off.
The cut-off for the assay was ≥ 10 milli-international units per milliliter (mIU/mL).
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off. | 8 Participants |
| Pooled Group I + II | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off. | 26 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off. | 12 Participants |
Secondary
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off
The cut-off for the assay was ≥ 5 ELISA unit per milliliter (EL.U/mL).
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off | Anti-FHA | 18 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off | Anti-PT | 18 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off | Anti-PRN | 17 Participants |
| Pooled Group I + II | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off | Anti-FHA | 41 Participants |
| Pooled Group I + II | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off | Anti-PT | 41 Participants |
| Pooled Group I + II | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off | Anti-PRN | 40 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off | Anti-PT | 61 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off | Anti-PRN | 60 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off | Anti-FHA | 61 Participants |
Secondary
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres
The cut-off for the assay was ≥ 8.
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres | Anti-Polio 2 | 12 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres | Anti-Polio 1 | 12 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres | Anti-Polio 3 | 10 Participants |
| Pooled Group I + II | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres | Anti-Polio 2 | 22 Participants |
| Pooled Group I + II | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres | Anti-Polio 1 | 22 Participants |
| Pooled Group I + II | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres | Anti-Polio 3 | 21 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres | Anti-Polio 1 | 29 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres | Anti-Polio 3 | 29 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres | Anti-Polio 2 | 29 Participants |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
The cut-off for the assay was ≥ 1.0 microgram per milliliter (μg/mL).
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off | 16 Participants |
| Pooled Group I + II | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off | 38 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off | 60 Participants |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
The cut-off for the assay was ≥ 0.15 microgram per milliliter (μg/mL).
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off | 18 Participants |
| Pooled Group I + II | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off | 41 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off | 63 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Any was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Time frame: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants Pooled Group I + II) and Full term group (i.e. Synflorix™ + Infanrix™ Hexa Group III).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any loss of appetite, Post Dose 1 | 36 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 drowsiness, Post Dose 1 | 2 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any fever(rectally), Post Dose 1 | 38 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 fever(rectally), Post Dose 1 | 1 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any irritability, Post Dose 1 | 73 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 irritability, Post Dose 1 | 9 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any drowsiness, Post Dose 1 | 53 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite, Post Dose 1 | 0 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any drowsiness, Post Dose 2 | 34 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 drowsiness, Post Dose 2 | 0 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any fever(rectally), Post Dose 2 | 34 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 fever(rectally), Post Dose 2 | 0 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any irritability, Post Dose 2 | 53 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 irritability, Post Dose 2 | 2 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any loss of appetite, Post Dose 2 | 23 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite, Post Dose 2 | 0 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any drowsiness, Post Dose 3 | 22 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 drowsiness, Post Dose 3 | 1 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any fever(rectally), Post Dose 3 | 25 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 fever(rectally), Post Dose 3 | 1 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any irritability, Post Dose 3 | 44 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 irritability, Post Dose 3 | 1 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any loss of appetite, Post Dose 3 | 22 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite, Post Dose 3 | 0 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any loss of appetite, Post Dose 3 | 26 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any drowsiness, Post Dose 1 | 44 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any irritability, Post Dose 2 | 51 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 drowsiness, Post Dose 1 | 1 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any fever(rectally), Post Dose 3 | 16 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any fever(rectally), Post Dose 1 | 41 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 irritability, Post Dose 2 | 4 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 fever(rectally), Post Dose 1 | 0 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 irritability, Post Dose 3 | 3 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any irritability, Post Dose 1 | 53 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any loss of appetite, Post Dose 2 | 35 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 irritability, Post Dose 1 | 6 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 fever(rectally), Post Dose 3 | 0 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any loss of appetite, Post Dose 1 | 33 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite, Post Dose 2 | 2 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite, Post Dose 1 | 0 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite, Post Dose 3 | 1 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any drowsiness, Post Dose 2 | 32 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any drowsiness, Post Dose 3 | 18 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 drowsiness, Post Dose 2 | 1 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any irritability, Post Dose 3 | 40 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any fever(rectally), Post Dose 2 | 40 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 drowsiness, Post Dose 3 | 4 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 fever(rectally), Post Dose 2 | 0 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed included 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 greater than (\>) 30 millimeters (mm). Any was defined as incidence of the specified symptom regardless of intensity.
Time frame: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants Pooled Group I + II) and Full term group (i.e. Synflorix™ + Infanrix™ Hexa Group III).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 pain, Post Dose 1 | 6 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 redness, Post Dose 2 | 7 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any swelling, Post Dose 1 | 67 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any swelling, Post Dose 2 | 60 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any pain, Post Dose 1 | 58 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling, Post Dose 2 | 4 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling, Post Dose 1 | 2 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any pain, Post Dose 3 | 42 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any redness, Post Dose 1 | 67 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 pain, Post Dose 3 | 6 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any pain, Post Dose 2 | 39 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any redness, Post Dose 3 | 66 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any redness, Post Dose 2 | 72 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 redness, Post Dose 3 | 9 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 pain, Post Dose 2 | 1 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any swelling, Post Dose 3 | 58 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 redness, Post Dose 1 | 0 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling, Post Dose 3 | 6 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any redness, Post Dose 2 | 41 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any pain, Post Dose 1 | 40 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 pain, Post Dose 1 | 6 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any redness, Post Dose 1 | 39 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 redness, Post Dose 1 | 1 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any swelling, Post Dose 1 | 30 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling, Post Dose 1 | 1 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any pain, Post Dose 2 | 39 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 pain, Post Dose 2 | 9 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling, Post Dose 3 | 2 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 redness, Post Dose 2 | 0 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any swelling, Post Dose 2 | 30 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling, Post Dose 2 | 0 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any pain, Post Dose 3 | 30 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 pain, Post Dose 3 | 3 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any redness, Post Dose 3 | 33 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 redness, Post Dose 3 | 3 Participants |
| Pooled Group I + II | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any swelling, Post Dose 3 | 24 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Time frame: Throughout the entire study period starting from the first vaccine dose administration (Month 0) up to the end of the 6-month safety follow-up (ESFU- Month 10).
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants Pooled Group I + II) and Full term group (i.e. Synflorix™ + Infanrix™ Hexa Group III).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any Serious Adverse Events (SAEs) | 19 Participants |
| Pooled Group I + II | Number of Subjects With Any Serious Adverse Events (SAEs) | 29 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Time frame: Throughout the active phase of the study (from the first vaccine administration (Month 0) up to 1 month after the third vaccine administration (Month5).
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants Pooled Group I + II) and Full term group (i.e. Synflorix™ + Infanrix™ Hexa Group III).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any Serious Adverse Events (SAEs) | 13 Participants |
| Pooled Group I + II | Number of Subjects With Any Serious Adverse Events (SAEs) | 18 Participants |
Secondary
Number of Subjects With Any 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 was 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 vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants Pooled Group I + II) and Full term group (i.e. Synflorix™ + Infanrix™ Hexa Group III).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 58 Participants |
| Pooled Group I + II | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 43 Participants |
Secondary
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
The cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | Anti-6A | 32 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | Anti-19A | 26 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | Anti-6A | 68 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | Anti-19A | 72 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | Anti-6A | 114 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | Anti-19A | 120 Participants |
Secondary
Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) ≥ the Cut-off
The cut-off for the assay was ≥ 100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) ≥ the Cut-off | 42 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) ≥ the Cut-off | 82 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) ≥ the Cut-off | 130 Participants |
Secondary
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
The cut-off for the assay was ≥ 0.20 microgram per mililiter (μg/ mL).
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-1 | 41 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-4 | 40 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-5 | 42 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-6B | 38 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-7F | 41 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-9V | 40 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-14 | 41 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-18C | 41 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-19F | 42 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-23F | 39 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-19F | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-1 | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-9V | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-7F | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-4 | 81 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-23F | 79 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-18C | 81 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-5 | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-14 | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-6B | 78 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-18C | 130 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-6B | 123 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-7F | 131 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-9V | 132 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-19F | 132 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-14 | 132 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-1 | 129 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-23F | 125 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-4 | 130 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off | Anti-5 | 129 Participants |
Secondary
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
The cut-off for the assay was ≥ 0.05 microgram per mililiter (μg/mL).
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the ATP cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-1 | 42 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-4 | 41 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-5 | 42 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-6B | 40 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-7F | 41 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-9V | 41 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-14 | 41 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-18C | 41 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-19F | 42 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-23F | 39 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-19F | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-1 | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-9V | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-7F | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-4 | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-23F | 81 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-18C | 81 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-5 | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-14 | 82 Participants |
| Pooled Group I + II | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-6B | 81 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-18C | 131 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-6B | 131 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-7F | 131 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-9V | 132 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-19F | 132 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-14 | 132 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-1 | 130 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-23F | 129 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-4 | 130 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Anti-5 | 129 Participants |
Secondary
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
The cut-off for the assay was ≥ 8.
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | Opsono-6A | 25 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | Opsono-19A | 2 Participants |
| Pooled Group I + II | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | Opsono-6A | 54 Participants |
| Pooled Group I + II | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | Opsono-19A | 10 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | Opsono-6A | 58 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off | Opsono-19A | 17 Participants |
Secondary
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
The cut-off for the assay was ≥ 8
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-1 | 20 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-4 | 36 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-5 | 29 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-6B | 30 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-7F | 36 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-9V | 36 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-14 | 36 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-18C | 34 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-19F | 31 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-23F | 35 Participants |
| Pooled Group I + II | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-19F | 71 Participants |
| Pooled Group I + II | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-1 | 49 Participants |
| Pooled Group I + II | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-9V | 72 Participants |
| Pooled Group I + II | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-7F | 74 Participants |
| Pooled Group I + II | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-4 | 72 Participants |
| Pooled Group I + II | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-23F | 70 Participants |
| Pooled Group I + II | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-18C | 65 Participants |
| Pooled Group I + II | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-5 | 69 Participants |
| Pooled Group I + II | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-14 | 73 Participants |
| Pooled Group I + II | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-6B | 59 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-18C | 99 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-6B | 85 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-7F | 113 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-9V | 103 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-19F | 105 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-14 | 110 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-1 | 80 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-23F | 109 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-4 | 110 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off | Opsono-5 | 104 Participants |
Secondary
Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Vaccine response to PT, FHA and PRN was defined as appearance of antibodies in subjects who are initially seronegative (S-), or at least maintenance of pre-vaccination antibody concentrations in those who are initially seropositive (S+). For the SYNFLORIX™ + INFANRIX™ HEXA GROUP I, no subjects presented initial seropositivity for PT and PRN antigens.
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, S- | 18 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, S+ | 0 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, S- | 15 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, S+ | 3 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, S- | 17 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, S+ | 0 Participants |
| Pooled Group I + II | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, S+ | 4 Participants |
| Pooled Group I + II | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, S- | 27 Participants |
| Pooled Group I + II | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, S+ | 17 Participants |
| Pooled Group I + II | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, S- | 34 Participants |
| Pooled Group I + II | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, S+ | 8 Participants |
| Pooled Group I + II | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, S- | 22 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, S+ | 12 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, S- | 18 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, S+ | 12 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, S+ | 41 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, S- | 45 Participants |
| Synflorix™ + Infanrix™ Hexa Group III | Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, S- | 45 Participants |
Secondary
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Seropositivity status was defined as opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.
Time frame: One month after the 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-6A | 114.5 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-19A | 4.5 Titers |
| Pooled Group I + II | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-6A | 157.3 Titers |
| Pooled Group I + II | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-19A | 7.1 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-6A | 49.5 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-19A | 7 Titers |
Secondary
Opsonophagocytic Activity 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 3rd vaccine dose (Month 5)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. 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™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1 | 23 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4 | 644.1 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5 | 45.2 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B | 278.3 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F | 4086.3 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V | 930.5 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14 | 775.4 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C | 262.5 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F | 104.2 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F | 1659.4 Titers |
| Pooled Group I + II | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F | 201.1 Titers |
| Pooled Group I + II | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1 | 30.3 Titers |
| Pooled Group I + II | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V | 837.9 Titers |
| Pooled Group I + II | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F | 3047.3 Titers |
| Pooled Group I + II | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4 | 500.9 Titers |
| Pooled Group I + II | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F | 1147.2 Titers |
| Pooled Group I + II | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C | 321.5 Titers |
| Pooled Group I + II | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5 | 70.8 Titers |
| Pooled Group I + II | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14 | 901.6 Titers |
| Pooled Group I + II | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B | 305.1 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C | 251 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B | 268.2 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F | 2395.2 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V | 1144.8 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F | 182.7 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14 | 644.6 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1 | 46.3 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F | 1558.8 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4 | 543.5 Titers |
| Synflorix™ + Infanrix™ Hexa Group III | Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5 | 94.8 Titers |