Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Conditions
Brief summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born children at the age of 16-18 months. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number =NCT00390910 ). Subjects participating in this study should have received three doses of pneumococcal vaccine in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALGSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)
Single dose, intramuscular injection
BIOLOGICALInfanrix™-IPV/Hib
Single dose, intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 16-18 months of age at the time of the booster vaccination. * A male or female who previously participated in study 107737 and received three doses of pneumococcal conjugate vaccine. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up). * Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccine. * Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month (30 days) before the booster dose of study vaccines (Visit 1) and up to the follow-up visit (Visit 2). * Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae other than the study vaccines from study 107737 * History of or intercurrent diphtheria, tetanus, hepatitis B, pertussis, polio, Haemophilus influenzae type b disease. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of seizures or progressive neurological disease * Acute disease at the time of enrolment. * Febrile illness defined as oral, axillary or tympanic temperature \< 37.5°C / rectal temperature \< 38°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject. * 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 three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | Within 4-days (Day 0-3) after booster vaccination | Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited General Symptoms | Within 4-days (Day 0-3) after booster vaccination | 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 is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | Within 31-days (Day 0-30) after booster vaccination | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined as incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the active phase of the study (Month 0 to Month 1) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine | A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL). |
| Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | A seroprotected subjects was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The anti-pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
| Antibody Concentrations Against Pneumococcal Serotypes | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | Seropositivity status was defined as the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs). |
| Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine | A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 6A and 19A concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL). |
| Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | Seropositivity status was defined as the anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs). |
| Number of Seropositive Subjects for Protein D Antibodies (Anti-PD) | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | A seropositive subject was defined as a subject who had anti-PD concentration greater than or equal to (≥) the value of 100 ELISA units per milliliter (EL.U/mL). |
| Antibody Concentrations Against Protein D (Anti-PD) | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | Seropositivity status was defined as the anti-protein D (Anti-PD) antibody concentrations greater than or equal to (≥) 100 ELISA units per milliliter (EL.U/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs). |
| Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | A seroprotected subject was defined as a subject who had anti-DT and anti-TT concentrations greater than or equal to (≥) the value of 0.1 international units per milliliter (IU/mL). |
| Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | Seropositivity status was defined as the anti-diphtheria toxoid (Anti-DT) and anti-tetanus toxoid (Anti-TT) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within 4-days (Day 0-3) after booster vaccination | 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 larger than (\>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity. |
| Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | The concentration of anti-polyribosyl-ribitol phosphate (Anti-PRP) antibody assessed was greater than or equal to (≥) the value of 1.0 micrograms per milliliter (µg /mL). |
| Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP) | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine | Seropositivity status was defined as the anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg /mL) and ≥ 1.0 µg/mL. Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs). |
| Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | A seropositive subject was defined as a subject who had anti-PT, anti-FHA and anti-PRN concentrations greater than or equal to (≥) the value of 5 ELISA units per milliliter (EL.U/mL). |
| Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | Seropositivity status was defined as the anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U /mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs). |
| Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | Vaccine response was defined as antibody concentrations ≥ 5 EL.U/mL at post-booster, for initially seronegative subjects (S-) (with concentrations \< 5 EL.U/mL) and for initially seropositive subjects (S+) (with concentrations ≥ 5 EL.U/mL), antibody concentrations at post-booster ≥ 2 fold the pre-vaccination antibody concentration. |
| Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | A seroprotected subject was defined as a subject who had anti-polio types 1, 2 and 3 titers greater than or equal to (≥) the value of 8. |
| Antibody Titers Against Anti-polio Type 1, 2 and 3 | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | Seroprotection status was defined as the anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers greater than or equal to (≥) the cut-off value of 8, presented as geometric mean titers (GMTs). |
| Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs) | Prior to (Pre-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | Seroprotection status was defined as the Anti-HBs antibody concentrations greater than or equal to (≥) 10 milli international units per milliliter (mIU/mL), presented as geometric mean concentrations (GMCs). |
| Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | A seropositive subject was defines as a subject with opsonophagocytic activity cut-off value greater than or equal to (≥) the value of 8. The vaccine pneumococcal serotypes investigated were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
| Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs). |
| Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | A seropositive subject was defined as a subject with opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A greater than or equal to (≥) the cut-off value of 8. |
| Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs). |
| Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine | A seroprotected subject was defined as a subject who had anti-PRP concentrations greater than or equal to (≥) the value of 0.15 micrograms per milliliter (µg /mL). |
Countries
Greece, Spain
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Preterm I Group Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age. | 44 |
| Preterm II Group Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age. | 72 |
| Full Term Group Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age. | 129 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 3 |
Baseline characteristics
| Characteristic | Preterm I Group | Preterm II Group | Full Term Group | Total |
|---|---|---|---|---|
| Age, Continuous | 16.8 Months STANDARD_DEVIATION 0.63 | 17.2 Months STANDARD_DEVIATION 0.68 | 16.6 Months STANDARD_DEVIATION 0.73 | 16.81 Months STANDARD_DEVIATION 0.74 |
| Sex: Female, Male Female | 16 Participants | 29 Participants | 50 Participants | 95 Participants |
| Sex: Female, Male Male | 28 Participants | 43 Participants | 79 Participants | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 71 / 116 | 98 / 129 |
| serious Total, serious adverse events | 3 / 116 | 1 / 129 |
Outcome results
Primary
Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)
Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.
Time frame: Within 4-days (Day 0-3) after booster vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preterm Group | Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | 8 Subjects |
| Full Term Group | Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) | 6 Subjects |
Secondary
Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)
Seropositivity status was defined as the anti-diphtheria toxoid (Anti-DT) and anti-tetanus toxoid (Anti-TT) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable 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) |
|---|---|---|---|
| Preterm Group | Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-DT, Post-booster [N=21;34;60] | 6.252 IU/mL |
| Preterm Group | Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-TT, Post-booster [N=21;34;60] | 12.374 IU/mL |
| Preterm Group | Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-TT, Pre-booster [N=23;32;59] | 0.821 IU/mL |
| Preterm Group | Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-DT, Pre-booster [N=23;31;59] | 0.381 IU/mL |
| Full Term Group | Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-DT, Post-booster [N=21;34;60] | 9.982 IU/mL |
| Full Term Group | Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-TT, Post-booster [N=21;34;60] | 14.392 IU/mL |
| Full Term Group | Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-DT, Pre-booster [N=23;31;59] | 0.674 IU/mL |
| Full Term Group | Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-TT, Pre-booster [N=23;32;59] | 0.726 IU/mL |
| Full Term Group | Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-TT, Post-booster [N=21;34;60] | 13.026 IU/mL |
| Full Term Group | Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-TT, Pre-booster [N=23;32;59] | 0.918 IU/mL |
| Full Term Group | Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-DT, Pre-booster [N=23;31;59] | 0.481 IU/mL |
| Full Term Group | Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-DT, Post-booster [N=21;34;60] | 6.730 IU/mL |
Secondary
Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs)
Seroprotection status was defined as the Anti-HBs antibody concentrations greater than or equal to (≥) 10 milli international units per milliliter (mIU/mL), presented as geometric mean concentrations (GMCs).
Time frame: Prior to (Pre-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Preterm Group | Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs) | 21.9 mIU/mL |
| Full Term Group | Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs) | 117.2 mIU/mL |
| Full Term Group | Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs) | 37.2 mIU/mL |
Secondary
Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Seropositivity status was defined as the anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U /mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable 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) |
|---|---|---|---|
| Preterm Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, Pre-booster [N=22;32;58] | 5.7 EL.U/mL |
| Preterm Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, Post-booster [N=21;34;59] | 38.4 EL.U/mL |
| Preterm Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, Pre-booster [N=20;27;47] | 39.4 EL.U/mL |
| Preterm Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, Post-booster [N=21;34;59] | 250.3 EL.U/mL |
| Preterm Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, Post-booster [N=21;34;60] | 259.7 EL.U/mL |
| Preterm Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, Pre-booster [N=23;32;59] | 16.7 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, Pre-booster [N=22;32;58] | 3.8 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, Pre-booster [N=23;32;59] | 10.3 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, Post-booster [N=21;34;59] | 32.7 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, Post-booster [N=21;34;60] | 286.5 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, Pre-booster [N=20;27;47] | 13.7 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, Post-booster [N=21;34;59] | 275.3 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, Pre-booster [N=20;27;47] | 17.0 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, Pre-booster [N=23;32;59] | 11.3 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, Post-booster [N=21;34;60] | 264.5 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, Pre-booster [N=22;32;58] | 5.5 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, Post-booster [N=21;34;59] | 45.1 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, Post-booster [N=21;34;59] | 229.0 EL.U/mL |
Secondary
Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP)
Seropositivity status was defined as the anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg /mL) and ≥ 1.0 µg/mL. Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable 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) |
|---|---|---|---|
| Preterm Group | Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP) | Anti-PRP, Post-booster [N=20;34;59] | 33.731 µg/mL |
| Preterm Group | Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP) | Anti-PRP, Pre-booster [N=23;32;59] | 0.376 µg/mL |
| Full Term Group | Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP) | Anti-PRP, Pre-booster [N=23;32;59] | 0.509 µg/mL |
| Full Term Group | Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP) | Anti-PRP, Post-booster [N=20;34;59] | 36.902 µg/mL |
| Full Term Group | Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP) | Anti-PRP, Pre-booster [N=23;32;59] | 0.577 µg/mL |
| Full Term Group | Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP) | Anti-PRP, Post-booster [N=20;34;59] | 38.713 µg/mL |
Secondary
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Seropositivity status was defined as the anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable 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) |
|---|---|---|---|
| Preterm Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-6A, Post-booster [N=42;66;118] | 0.70 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-19A, Post-booster [N=42;66;118] | 0.65 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-6A, Pre-booster [N=42;67;122] | 0.12 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-19A, Pre-booster [N=43;67;121] | 0.14 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-6A, Pre-booster [N=42;67;122] | 0.12 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-6A, Post-booster [N=42;66;118] | 0.77 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-19A, Pre-booster [N=43;67;121] | 0.15 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-19A, Post-booster [N=42;66;118] | 0.93 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-6A, Post-booster [N=42;66;118] | 0.79 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-19A, Pre-booster [N=43;67;121] | 0.16 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-19A, Post-booster [N=42;66;118] | 1.10 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-6A, Pre-booster [N=42;67;122] | 0.14 µg/mL |
Secondary
Antibody Concentrations Against Pneumococcal Serotypes
Seropositivity status was defined as the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable 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) |
|---|---|---|---|
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4, Pre-booster [N=43;69;123] | 0.25 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1, Post-booster [N=43;66;119] | 1.57 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1, Pre-booster [N=43;66;121] | 0.15 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F, Post-booster [N=42;66;119] | 2.70 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B, Post-booster [N=42;66;119] | 2.44 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V, Pre-booster [N=43;69;123] | 0.51 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14, Post-booster [N=43;66;119] | 4.88 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F, Pre-booster [N=43;68;125] | 0.86 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C, Pre-booster [N=43;68;125] | 0.58 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F, Pre-booster [N=43;69;123] | 0.27 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C, Post-booster [N=43;66;119] | 9.51 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B, Pre-booster [N=43;67;124] | 0.28 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V, Post-booster [N=43;66;119] | 2.87 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5, Post-booster [N=43;66;119] | 1.84 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14, Pre-booster [N=43;68;124] | 0.78 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F, Post-booster [N=43;66;119] | 6.83 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5, Pre-booster [N=43;68;124] | 0.24 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F, Post-booster [N=43;66;118] | 3.11 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4, Post-booster [N=43;66;119] | 2.98 µg/mL |
| Preterm Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F, Pre-booster [N=43;65;123] | 0.42 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F, Post-booster [N=43;66;118] | 4.16 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B, Post-booster [N=42;66;119] | 2.46 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F, Pre-booster [N=43;65;123] | 0.46 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4, Post-booster [N=43;66;119] | 3.67 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V, Pre-booster [N=43;69;123] | 0.42 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14, Pre-booster [N=43;68;124] | 0.48 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14, Post-booster [N=43;66;119] | 5.14 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C, Post-booster [N=43;66;119] | 13.20 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F, Post-booster [N=42;66;119] | 3.45 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V, Post-booster [N=43;66;119] | 3.47 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C, Pre-booster [N=43;68;125] | 0.56 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F, Pre-booster [N=43;68;125] | 1.07 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1, Pre-booster [N=43;66;121] | 0.14 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1, Post-booster [N=43;66;119] | 1.74 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4, Pre-booster [N=43;69;123] | 0.24 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5, Pre-booster [N=43;68;124] | 0.27 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5, Post-booster [N=43;66;119] | 2.38 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B, Pre-booster [N=43;67;124] | 0.30 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F, Post-booster [N=43;66;119] | 9.78 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F, Pre-booster [N=43;69;123] | 0.30 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F, Pre-booster [N=43;68;125] | 1.27 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4, Pre-booster [N=43;69;123] | 0.30 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C, Pre-booster [N=43;68;125] | 0.60 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4, Post-booster [N=43;66;119] | 4.23 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14, Pre-booster [N=43;68;124] | 0.68 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F, Pre-booster [N=43;65;123] | 0.66 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5, Pre-booster [N=43;68;124] | 0.40 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V, Post-booster [N=43;66;119] | 4.17 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F, Post-booster [N=42;66;119] | 3.30 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5, Post-booster [N=43;66;119] | 2.58 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V, Pre-booster [N=43;69;123] | 0.59 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14, Post-booster [N=43;66;119] | 5.98 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B, Post-booster [N=42;66;119] | 2.67 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F, Pre-booster [N=43;69;123] | 0.42 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B, Pre-booster [N=43;67;124] | 0.37 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1, Pre-booster [N=43;66;121] | 0.17 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F, Post-booster [N=43;66;119] | 9.72 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F, Post-booster [N=43;66;118] | 3.93 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1, Post-booster [N=43;66;119] | 1.98 µg/mL |
| Full Term Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C, Post-booster [N=43;66;119] | 12.38 µg/mL |
Secondary
Antibody Concentrations Against Protein D (Anti-PD)
Seropositivity status was defined as the anti-protein D (Anti-PD) antibody concentrations greater than or equal to (≥) 100 ELISA units per milliliter (EL.U/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable 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) |
|---|---|---|---|
| Preterm Group | Antibody Concentrations Against Protein D (Anti-PD) | Anti-PD, Post-booster [N=43;66;118] | 1892.9 EL.U/mL |
| Preterm Group | Antibody Concentrations Against Protein D (Anti-PD) | Anti-PD, Pre-booster [N=42;67;123] | 478.3 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Protein D (Anti-PD) | Anti-PD, Pre-booster [N=42;67;123] | 340.0 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Protein D (Anti-PD) | Anti-PD, Post-booster [N=43;66;118] | 1576.5 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Protein D (Anti-PD) | Anti-PD, Pre-booster [N=42;67;123] | 383.7 EL.U/mL |
| Full Term Group | Antibody Concentrations Against Protein D (Anti-PD) | Anti-PD, Post-booster [N=43;66;118] | 1533.6 EL.U/mL |
Secondary
Antibody Titers Against Anti-polio Type 1, 2 and 3
Seroprotection status was defined as the anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers greater than or equal to (≥) the cut-off value of 8, presented as geometric mean titers (GMTs).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable 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) |
|---|---|---|---|
| Preterm Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 1, Pre-booster [N=17;29;53] | 52.3 Titers |
| Preterm Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 2, Post-booster [N=3;8;20] | 1290.1 Titers |
| Preterm Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 3, Post-booster [N=3;8;20] | 574.7 Titers |
| Preterm Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 1, Post-booster [N=3;8;20] | 512.0 Titers |
| Preterm Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 3, Pre-booster [N=17;29;53] | 23.0 Titers |
| Preterm Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 2, Pre-booster [N=17;29;53] | 65.2 Titers |
| Full Term Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 3, Pre-booster [N=17;29;53] | 31.3 Titers |
| Full Term Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 3, Post-booster [N=3;8;20] | 1448.1 Titers |
| Full Term Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 2, Pre-booster [N=17;29;53] | 47.3 Titers |
| Full Term Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 1, Pre-booster [N=17;29;53] | 34.8 Titers |
| Full Term Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 1, Post-booster [N=3;8;20] | 1386.7 Titers |
| Full Term Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 2, Post-booster [N=3;8;20] | 2048.0 Titers |
| Full Term Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 2, Post-booster [N=3;8;20] | 1116.9 Titers |
| Full Term Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 1, Post-booster [N=3;8;20] | 1327.9 Titers |
| Full Term Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 2, Pre-booster [N=17;29;53] | 50.9 Titers |
| Full Term Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 1, Pre-booster [N=17;29;53] | 54.7 Titers |
| Full Term Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 3, Pre-booster [N=17;29;53] | 84.3 Titers |
| Full Term Group | Antibody Titers Against Anti-polio Type 1, 2 and 3 | Anti-Polio 3, Post-booster [N=3;8;20] | 1692.5 Titers |
Secondary
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
A seropositive subject was defined as a subject who had anti-PT, anti-FHA and anti-PRN concentrations greater than or equal to (≥) the value of 5 ELISA units per milliliter (EL.U/mL).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, Post-booster [N=21;34;59] | 21 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, Pre-booster [N=22;32;58] | 10 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, Post-booster [N=21;34;60] | 21 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, Post-booster [N=21;34;59] | 21 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, Pre-booster [N=20;27;47] | 19 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, Pre-booster [N=23;32;59] | 20 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, Post-booster [N=21;34;59] | 34 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, Post-booster [N=21;34;59] | 34 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, Pre-booster [N=23;32;59] | 28 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, Post-booster [N=21;34;60] | 34 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, Pre-booster [N=22;32;58] | 11 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, Pre-booster [N=20;27;47] | 24 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, Post-booster [N=21;34;59] | 59 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, Post-booster [N=21;34;59] | 59 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, Pre-booster [N=22;32;58] | 30 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, Pre-booster [N=20;27;47] | 43 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, Post-booster [N=21;34;60] | 60 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, Pre-booster [N=23;32;59] | 47 Subjects |
Secondary
Number of Seropositive Subjects for Anti-pneumococcal Serotypes
A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-5, Pre-booster [N=43;68;124] | 41 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-6B, Post-booster [N=42;66;119] | 42 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-9V, Pre-booster [N=43;69;123] | 43 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-5, Post-booster [N=43;66;119] | 43 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-18C, Post-booster [N=43;66;119] | 43 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-7F, Post-booster [N=43;66;118] | 43 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-6B, Pre-booster [N=43;67;124] | 41 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-1, Pre-booster [N=43;66;121] | 39 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-23F, Post-booster [N=42;66;119] | 41 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-7F, Pre-booster [N=43;65;123] | 42 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-18C, Pre-booster [N=43;68;125] | 43 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-1, Post-booster [N=43;66;119] | 43 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-19F, Pre-booster [N=43;68;125] | 43 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-14, Post-booster [N=43;66;119] | 43 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-4, Pre-booster [N=43;69;123] | 40 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-19F, Post-booster [N=43;66;119] | 43 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-14, Pre-booster [N=43;68;124] | 43 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-4, Post-booster [N=43;66;119] | 43 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-23F, Pre-booster [N=43;69;123] | 41 Subjects |
| Preterm Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-9V, Post-booster [N=43;66;119] | 43 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-18C, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-23F, Pre-booster [N=43;69;123] | 68 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-1, Pre-booster [N=43;66;121] | 56 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-1, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-4, Pre-booster [N=43;69;123] | 68 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-4, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-5, Pre-booster [N=43;68;124] | 66 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-5, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-6B, Pre-booster [N=43;67;124] | 66 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-6B, Post-booster [N=42;66;119] | 65 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-7F, Pre-booster [N=43;65;123] | 65 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-7F, Post-booster [N=43;66;118] | 66 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-9V, Pre-booster [N=43;69;123] | 69 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-9V, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-14, Pre-booster [N=43;68;124] | 68 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-14, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-18C, Pre-booster [N=43;68;125] | 68 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-19F, Pre-booster [N=43;68;125] | 68 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-19F, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-23F, Post-booster [N=42;66;119] | 66 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-18C, Post-booster [N=43;66;119] | 118 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-9V, Post-booster [N=43;66;119] | 119 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-4, Pre-booster [N=43;69;123] | 120 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-19F, Pre-booster [N=43;68;125] | 125 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-14, Pre-booster [N=43;68;124] | 121 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-1, Post-booster [N=43;66;119] | 119 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-19F, Post-booster [N=43;66;119] | 119 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-14, Post-booster [N=43;66;119] | 119 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-1, Pre-booster [N=43;66;121] | 111 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-23F, Post-booster [N=42;66;119] | 118 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-6B, Post-booster [N=42;66;119] | 119 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-18C, Pre-booster [N=43;68;125] | 123 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-7F, Pre-booster [N=43;65;123] | 123 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-5, Post-booster [N=43;66;119] | 119 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-23F, Pre-booster [N=43;69;123] | 122 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-7F, Post-booster [N=43;66;118] | 118 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-5, Pre-booster [N=43;68;124] | 122 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-6B, Pre-booster [N=43;67;124] | 119 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-9V, Pre-booster [N=43;69;123] | 123 Subjects |
| Full Term Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes | Anti-4, Post-booster [N=43;66;119] | 119 Subjects |
Secondary
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A
A seropositive subject was defined as a subject with opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A greater than or equal to (≥) the cut-off value of 8.
Time frame: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA Anti-6A, [N=34;50;95] | 31 Subjects |
| Preterm Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA Anti-19A, [N=38;52;95] | 23 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA Anti-6A, [N=34;50;95] | 45 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA Anti-19A, [N=38;52;95] | 30 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA Anti-6A, [N=34;50;95] | 79 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA Anti-19A, [N=38;52;95] | 56 Subjects |
Secondary
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes
A seropositive subject was defines as a subject with opsonophagocytic activity cut-off value greater than or equal to (≥) the value of 8. The vaccine pneumococcal serotypes investigated were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-1, [N=37;52;99] | 34 Subjects |
| Preterm Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-4, [N=36;55;100] | 35 Subjects |
| Preterm Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-5, [N=34;50;93] | 32 Subjects |
| Preterm Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-6B, [N=35;51;98] | 33 Subjects |
| Preterm Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-7F, [N=37;49;99] | 37 Subjects |
| Preterm Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-9V, [N=38;47;100] | 38 Subjects |
| Preterm Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-14, [N=36;52;99] | 36 Subjects |
| Preterm Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-18C, [N=37;50;100] | 37 Subjects |
| Preterm Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-19F, [N=36;52;96] | 36 Subjects |
| Preterm Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-23F, [N=37;54;99] | 37 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-19F, [N=36;52;96] | 51 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-1, [N=37;52;99] | 49 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-9V, [N=38;47;100] | 47 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-7F, [N=37;49;99] | 49 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-4, [N=36;55;100] | 55 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-23F, [N=37;54;99] | 54 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-18C, [N=37;50;100] | 50 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-5, [N=34;50;93] | 48 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-14, [N=36;52;99] | 52 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-6B, [N=35;51;98] | 49 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-18C, [N=37;50;100] | 100 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-6B, [N=35;51;98] | 92 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-7F, [N=37;49;99] | 99 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-9V, [N=38;47;100] | 100 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-19F, [N=36;52;96] | 96 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-14, [N=36;52;99] | 99 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-1, [N=37;52;99] | 93 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-23F, [N=37;54;99] | 99 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-4, [N=36;55;100] | 100 Subjects |
| Full Term Group | Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-5, [N=34;50;93] | 92 Subjects |
Secondary
Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A
A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 6A and 19A concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-6A, Pre-booster [N=42;67;122] | 34 Subjects |
| Preterm Group | Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-6A, Post-booster [N=42;66;118] | 41 Subjects |
| Preterm Group | Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-19A, Pre-booster [N=43;67;121] | 28 Subjects |
| Preterm Group | Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-19A, Post-booster [N=42;66;118] | 40 Subjects |
| Full Term Group | Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-19A, Post-booster [N=42;66;118] | 63 Subjects |
| Full Term Group | Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-6A, Pre-booster [N=42;67;122] | 51 Subjects |
| Full Term Group | Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-19A, Pre-booster [N=43;67;121] | 49 Subjects |
| Full Term Group | Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-6A, Post-booster [N=42;66;118] | 63 Subjects |
| Full Term Group | Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-19A, Post-booster [N=42;66;118] | 113 Subjects |
| Full Term Group | Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-6A, Post-booster [N=42;66;118] | 115 Subjects |
| Full Term Group | Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-19A, Pre-booster [N=43;67;121] | 95 Subjects |
| Full Term Group | Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A | Anti-6A, Pre-booster [N=42;67;122] | 98 Subjects |
Secondary
Number of Seropositive Subjects for Protein D Antibodies (Anti-PD)
A seropositive subject was defined as a subject who had anti-PD concentration greater than or equal to (≥) the value of 100 ELISA units per milliliter (EL.U/mL).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Seropositive Subjects for Protein D Antibodies (Anti-PD) | Anti-PD, Pre-booster [N=42;67;123] | 39 Subjects |
| Preterm Group | Number of Seropositive Subjects for Protein D Antibodies (Anti-PD) | Anti-PD, Post-booster [N=43;66;118] | 43 Subjects |
| Full Term Group | Number of Seropositive Subjects for Protein D Antibodies (Anti-PD) | Anti-PD, Pre-booster [N=42;67;123] | 58 Subjects |
| Full Term Group | Number of Seropositive Subjects for Protein D Antibodies (Anti-PD) | Anti-PD, Post-booster [N=43;66;118] | 66 Subjects |
| Full Term Group | Number of Seropositive Subjects for Protein D Antibodies (Anti-PD) | Anti-PD, Pre-booster [N=42;67;123] | 114 Subjects |
| Full Term Group | Number of Seropositive Subjects for Protein D Antibodies (Anti-PD) | Anti-PD, Post-booster [N=43;66;118] | 117 Subjects |
Secondary
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)
A seroprotected subject was defined as a subject who had anti-DT and anti-TT concentrations greater than or equal to (≥) the value of 0.1 international units per milliliter (IU/mL).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-DT, Post-booster [N=21;34;60] | 21 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-TT, Post-booster [N=21;34;60] | 21 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-TT, Pre-booster [N=23;32;59] | 23 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-DT, Pre-booster [N=23;31;59] | 20 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-DT, Pre-booster [N=23;31;59] | 27 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-DT, Post-booster [N=21;34;60] | 34 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-TT, Pre-booster [N=23;32;59] | 32 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-TT, Post-booster [N=21;34;60] | 34 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-DT, Pre-booster [N=23;31;59] | 51 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-TT, Pre-booster [N=23;32;59] | 59 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-DT, Post-booster [N=21;34;60] | 60 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) | Anti-TT, Post-booster [N=21;34;60] | 60 Subjects |
Secondary
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes
A seroprotected subjects was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The anti-pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-1, Post-booster [N=43;66;119] | 43 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-18C, Pre-booster [N=43;68;125] | 36 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-6B, Pre-booster [N=43;67;124] | 28 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-19F, Post-booster [N=43;66;119] | 43 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-14, Post-booster [N=43;66;119] | 43 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-7F, Pre-booster [N=43;65;123] | 34 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-23F, Pre-booster [N=43;69;123] | 30 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-14, Pre-booster [N=43;68;124] | 41 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-7F, Post-booster [N=43;66;118] | 43 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-4, Pre-booster [N=43;69;123] | 23 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-9V, Post-booster [N=43;66;119] | 43 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-9V, Pre-booster [N=43;69;123] | 39 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-6B, Post-booster [N=42;66;119] | 42 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-4, Post-booster [N=43;66;119] | 43 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-23F, Post-booster [N=42;66;119] | 41 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-19F, Pre-booster [N=43;68;125] | 38 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-5, Pre-booster [N=43;68;124] | 27 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-1, Pre-booster [N=43;66;121] | 16 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-18C, Post-booster [N=43;66;119] | 43 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-5, Post-booster [N=43;66;119] | 43 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-19F, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-6B, Post-booster [N=42;66;119] | 65 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-9V, Pre-booster [N=43;69;123] | 59 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-1, Pre-booster [N=43;66;121] | 28 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-1, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-4, Pre-booster [N=43;69;123] | 40 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-4, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-5, Pre-booster [N=43;68;124] | 43 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-5, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-6B, Pre-booster [N=43;67;124] | 41 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-7F, Pre-booster [N=43;65;123] | 56 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-7F, Post-booster [N=43;66;118] | 66 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-9V, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-14, Pre-booster [N=43;68;124] | 55 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-14, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-18C, Pre-booster [N=43;68;125] | 60 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-18C, Post-booster [N=43;66;119] | 66 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-19F, Pre-booster [N=43;68;125] | 66 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-23F, Pre-booster [N=43;69;123] | 45 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-23F, Post-booster [N=42;66;119] | 66 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-6B, Post-booster [N=42;66;119] | 119 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-14, Post-booster [N=43;66;119] | 119 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-5, Post-booster [N=43;66;119] | 119 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-23F, Post-booster [N=42;66;119] | 118 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-18C, Pre-booster [N=43;68;125] | 106 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-5, Pre-booster [N=43;68;124] | 105 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-23F, Pre-booster [N=43;69;123] | 99 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-18C, Post-booster [N=43;66;119] | 118 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-4, Post-booster [N=43;66;119] | 119 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-4, Pre-booster [N=43;69;123] | 82 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-19F, Pre-booster [N=43;68;125] | 120 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-1, Post-booster [N=43;66;119] | 118 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-9V, Pre-booster [N=43;69;123] | 115 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-7F, Post-booster [N=43;66;118] | 118 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-1, Pre-booster [N=43;66;121] | 53 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-9V, Post-booster [N=43;66;119] | 119 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-7F, Pre-booster [N=43;65;123] | 115 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-19F, Post-booster [N=43;66;119] | 119 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-14, Pre-booster [N=43;68;124] | 105 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes | Anti-6B, Pre-booster [N=43;67;124] | 99 Subjects |
Secondary
Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3)
A seroprotected subject was defined as a subject who had anti-polio types 1, 2 and 3 titers greater than or equal to (≥) the value of 8.
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 1, Pre-booster [N=17;29;53] | 17 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 1, Post-booster [N=3;8;20] | 3 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 2, Pre-booster [N=17;29;53] | 17 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 2, Post-booster [N=3;8;20] | 3 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 3, Pre-booster [N=17;29;53] | 12 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 3, Post-booster [N=3;8;20] | 3 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 3, Post-booster [N=3;8;20] | 8 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 1, Pre-booster [N=17;29;53] | 22 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 2, Post-booster [N=3;8;20] | 8 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 3, Pre-booster [N=17;29;53] | 23 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 1, Post-booster [N=3;8;20] | 8 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 2, Pre-booster [N=17;29;53] | 26 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 1, Post-booster [N=3;8;20] | 20 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 2, Pre-booster [N=17;29;53] | 47 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 3, Post-booster [N=3;8;20] | 20 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 2, Post-booster [N=3;8;20] | 20 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 1, Pre-booster [N=17;29;53] | 49 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) | Anti-Polio 3, Pre-booster [N=17;29;53] | 51 Subjects |
Secondary
Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
A seroprotected subject was defined as a subject who had anti-PRP concentrations greater than or equal to (≥) the value of 0.15 micrograms per milliliter (µg /mL).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-PRP, Post-booster [N=20;34;59] | 20 Subjects |
| Preterm Group | Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-PRP, Pre-booster [N=23;32;59] | 16 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-PRP, Post-booster [N=20;34;59] | 34 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-PRP, Pre-booster [N=23;32;59] | 26 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-PRP, Pre-booster [N=23;32;59] | 50 Subjects |
| Full Term Group | Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-PRP, Post-booster [N=20;34;59] | 59 Subjects |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL
The concentration of anti-polyribosyl-ribitol phosphate (Anti-PRP) antibody assessed was greater than or equal to (≥) the value of 1.0 micrograms per milliliter (µg /mL).
Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL | Anti-PRP, Pre-booster [N=23;32;59] | 6 Subjects |
| Preterm Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL | Anti-PRP, Post-booster [N=20;34;59] | 20 Subjects |
| Full Term Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL | Anti-PRP, Pre-booster [N=23;32;59] | 9 Subjects |
| Full Term Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL | Anti-PRP, Post-booster [N=20;34;59] | 34 Subjects |
| Full Term Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL | Anti-PRP, Pre-booster [N=23;32;59] | 20 Subjects |
| Full Term Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL | Anti-PRP, Post-booster [N=20;34;59] | 59 Subjects |
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 is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Time frame: Within 4-days (Day 0-3) after booster vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 Irritability | 2 Subjects |
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 Drowsiness | 1 Subjects |
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any Fever | 34 Subjects |
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 Fever | 0 Subjects |
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any Irritability | 36 Subjects |
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 Loss of appetite | 0 Subjects |
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any Loss of appetite | 26 Subjects |
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any Drowsiness | 21 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any Irritability | 49 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any Drowsiness | 33 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any Loss of appetite | 35 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 Drowsiness | 1 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 Loss of appetite | 1 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Any Fever | 39 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 Irritability | 2 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms | Grade 3 Fever | 1 Subjects |
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 larger than (\>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity.
Time frame: Within 4-days (Day 0-3) after booster vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 47 Subjects |
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 5 Subjects |
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 35 Subjects |
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 3 Subjects |
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 27 Subjects |
| Preterm Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 1 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 55 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 67 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 19 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 4 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 14 Subjects |
| Full Term Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 65 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Throughout the active phase of the study (Month 0 to Month 1)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preterm Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| Full Term Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Throughout the entire study period starting from Month 0 up to the end of the extended safety follow-up (Month 6)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preterm Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Subjects |
| Full Term Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Subjects |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined as incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Time frame: Within 31-days (Day 0-30) after booster vaccination
Population: The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preterm Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 17 Subjects |
| Full Term Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 24 Subjects |
Secondary
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Vaccine response was defined as antibody concentrations ≥ 5 EL.U/mL at post-booster, for initially seronegative subjects (S-) (with concentrations \< 5 EL.U/mL) and for initially seropositive subjects (S+) (with concentrations ≥ 5 EL.U/mL), antibody concentrations at post-booster ≥ 2 fold the pre-vaccination antibody concentration.
Time frame: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT, S- [N=11;21;27] | 11 Subjects |
| Preterm Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN, S- [N=2;4;11] | 2 Subjects |
| Preterm Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA, S+ [N=17;24;39] | 17 Subjects |
| Preterm Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT, S+ [N=9;11;27] | 9 Subjects |
| Preterm Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN, S+ [N=19;28;45] | 19 Subjects |
| Preterm Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA, S- [N=1;3;4] | 1 Subjects |
| Full Term Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT, S+ [N=9;11;27] | 11 Subjects |
| Full Term Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT, S- [N=11;21;27] | 21 Subjects |
| Full Term Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA, S- [N=1;3;4] | 3 Subjects |
| Full Term Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA, S+ [N=17;24;39] | 24 Subjects |
| Full Term Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN, S- [N=2;4;11] | 4 Subjects |
| Full Term Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN, S+ [N=19;28;45] | 28 Subjects |
| Full Term Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN, S+ [N=19;28;45] | 44 Subjects |
| Full Term Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN, S- [N=2;4;11] | 11 Subjects |
| Full Term Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT, S+ [N=9;11;27] | 24 Subjects |
| Full Term Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT, S- [N=11;21;27] | 27 Subjects |
| Full Term Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA, S+ [N=17;24;39] | 37 Subjects |
| Full Term Group | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA, S- [N=1;3;4] | 4 Subjects |
Secondary
Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).
Time frame: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable 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) |
|---|---|---|---|
| Preterm Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA Anti-6A, [N=34;50;95] | 270.6 Titers |
| Preterm Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA Anti-19A, [N=38;52;95] | 31.9 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA Anti-6A, [N=34;50;95] | 218.2 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA Anti-19A, [N=38;52;95] | 41.4 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA Anti-6A, [N=34;50;95] | 207.4 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A | OPA Anti-19A, [N=38;52;95] | 51.7 Titers |
Secondary
Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes
Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).
Time frame: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable 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) |
|---|---|---|---|
| Preterm Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-1, [N=37;52;99] | 125 Titers |
| Preterm Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-4, [N=36;55;100] | 971.8 Titers |
| Preterm Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-5, [N=34;50;93] | 69.2 Titers |
| Preterm Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-6B, [N=35;51;98] | 659.0 Titers |
| Preterm Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-7F, [N=37;49;99] | 6008.9 Titers |
| Preterm Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-9V, [N=38;47;100] | 1666.4 Titers |
| Preterm Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-14, [N=36;52;99] | 1489.5 Titers |
| Preterm Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-18C, [N=37;50;100] | 1656.0 Titers |
| Preterm Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-19F, [N=36;52;96] | 379.3 Titers |
| Preterm Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-23F, [N=37;54;99] | 2881.8 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-19F, [N=36;52;96] | 486.3 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-1, [N=37;52;99] | 143.6 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-9V, [N=38;47;100] | 2192.5 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-7F, [N=37;49;99] | 4851.1 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-4, [N=36;55;100] | 1307.2 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-23F, [N=37;54;99] | 2510.2 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-18C, [N=37;50;100] | 1672.4 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-5, [N=34;50;93] | 120.0 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-14, [N=36;52;99] | 1895.3 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-6B, [N=35;51;98] | 459.1 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-18C, [N=37;50;100] | 1561.9 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-6B, [N=35;51;98] | 635.0 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-7F, [N=37;49;99] | 4372.6 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-9V, [N=38;47;100] | 1798.8 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-19F, [N=36;52;96] | 626.8 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-14, [N=36;52;99] | 1342.7 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-1, [N=37;52;99] | 170.9 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-23F, [N=37;54;99] | 3208.6 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-4, [N=36;55;100] | 1479.3 Titers |
| Full Term Group | Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes | OPA Anti-5, [N=34;50;93] | 176.9 Titers |