Infections, Streptococcal
Conditions
Keywords
Streptococcus pneumonia, pneumococcal conjugate vaccine
Brief summary
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 (NCT00307554). The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™. The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* a healthy male or female, 12 to 18 months of age at the time of vaccination, who received at least one dose of either pneumococcal conjugate vaccine or Prevenar™ during study 105553 and with written informed consent obtained from the parent/guardian of the subject.
Exclusion criteria
* use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the entire study period (active phase and safety follow-up). * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before vaccination up to Visit 2. * Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of study 105553. Children with a history of seizures or neurological disease, allergic disease, immunosuppressive or immunodeficient condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Post Booster Between the Synflorix-Synflorix and Prevenar-Prevenar Groups | Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 | Fever was measured as rectal temperature. Assessment of occurrences of rectal temperature \> 39.0 °C was performed post administration of the booster dose of pneumococcal vaccine (Synflorix™ or Prevenar™ vaccine) in this study. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 | Solicited general symptoms assessed include 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 everyday activities. 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. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | Within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007. |
| Number of Subjects With Serious Adverse Events (SAEs) During the Active Phase of the Study | Throughout the Active Phase of the study, that is, within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity . The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007. |
| Number of Subjects With Serious Adverse Events (SAEs) During the Entire Study | Throughout the study period, from Month 0 prior to booster vaccination up to Month 6, end of the ESFU in this study 10PN-PD-DIT-007 | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects enrolled in the ESFU Phase of the study. |
| Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Prior to (PRE) and one month after (Month 1) booster vaccination | A seroprotected subject as regards anti-pneumococcal serotype antibody was defined as a subject with anti-pneumococcal serotype antibody concentration above than or equal to (≥) 0.20 microgram per millilitre (μg/mL). Anti-pneumococcal serotypes antibodies assessed were antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F). Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using ≥ 0.05 μg/mL as seropositivity cut off. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. |
| Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Prior to (PRE) and one month (Month 1) post booster vaccination | Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean concentrations (GMCs), in microgram per millilitre (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Prior to (PRE) and one month (Month 1) post booster vaccination | OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available. |
| Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | Prior to (PRE) and one month (Month 1) post booster vaccination | Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off for the assay for the purpose of this endpoint was ≥ 0.15 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. |
| Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Prior to (PRE) and one month (Month 1) post booster vaccination | Anti-PT, Anti-FHA and Anti-PRN concentrations measured by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 5 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. |
| Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Prior to (PRE) and one month (Month 1) post booster vaccination | Anti-D and Anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 0.1 IU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. |
| Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | Prior to (PRE) and one month (Month 1) post booster vaccination | Anti-HBs antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in milli-International unit per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 10 mIU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. |
| Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Prior to (PRE) and one month (Month 1) post booster vaccination | Anti-Polio 1, 2 and 3 antibody titers were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seroprotection cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. |
| Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens | One month (Month 1) post booster vaccination | A BST responder to PT, FHA and PRN antigens was defined as a subject with the appearance of antibodies in subjects who were seronegative prior to the booster vaccination or at least 2-fold increase of pre-booster vaccination antibody concentrations in subjects who were seropositive prior to the booster vaccination. A seropositive/seronegative subject as regards Anti-PT/-FHA/ -PRN antibodies was defined as a subject with anti-PT/-FHA/ -PRN antibody concentrations ≥ 5 Enzyme-linked Immunosorbent assay (ELISA) unit per milli-liter (EL.U/mL) |
| Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA) | Prior to (PRE) and one month (Month 1) post booster vaccination | Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. |
Countries
Finland, France, Poland
Participant flow
Recruitment details
This study consisted of approximately 1200 subjects who were previously enrolled and had been vaccinated with either the 10Pn or 7Pn vaccine as part of the 10PN-PD-DIT-001 (105553) study (EudraCTnumber: 2005-003300-11).
Pre-assignment details
During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected. Prior to vaccination, subjects' pre-vaccination body temperature was evaluated.
Participants by arm
| Arm | Count |
|---|---|
| Synflorix-Synflorix Group This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly \[IM\] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. | 737 |
| Prevenar-Prevenar Group This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly \[IM\] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. | 92 |
| Prevenar-Synflorix Group This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly \[IM\] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. | 283 |
| Total | 1,112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Synflorix-Synflorix Group | Prevenar-Prevenar Group | Prevenar-Synflorix Group | Total |
|---|---|---|---|---|
| Age, Continuous | 15.3 Months STANDARD_DEVIATION 2.08 | 14.2 Months STANDARD_DEVIATION 2.26 | 14.2 Months STANDARD_DEVIATION 2.23 | 14.93 Months STANDARD_DEVIATION 2.19 |
| Sex: Female, Male Female | 360 Participants | 50 Participants | 134 Participants | 544 Participants |
| Sex: Female, Male Male | 377 Participants | 42 Participants | 149 Participants | 568 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 737 | 0 / 92 | 0 / 283 |
| other Total, other adverse events | 684 / 737 | 85 / 92 | 253 / 283 |
| serious Total, serious adverse events | 33 / 737 | 6 / 92 | 8 / 93 |
Outcome results
Primary
Number of Subjects With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Post Booster Between the Synflorix-Synflorix and Prevenar-Prevenar Groups
Fever was measured as rectal temperature. Assessment of occurrences of rectal temperature \> 39.0 °C was performed post administration of the booster dose of pneumococcal vaccine (Synflorix™ or Prevenar™ vaccine) in this study. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.
Time frame: Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Population: The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix-Synflorix Group | Number of Subjects With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Post Booster Between the Synflorix-Synflorix and Prevenar-Prevenar Groups | 24 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Post Booster Between the Synflorix-Synflorix and Prevenar-Prevenar Groups | 7 Participants |
Comparison: Analysis aimed at demonstrating the non-inferiority of Synflorix™ vs Prevenar™ vaccine, both co-administered with Infanrix hexa™ vaccine, in terms of post-immunization febrile reactions with rectal fever \> 39.0°C.95% CI: [-11.85, -0.21]
Secondary
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA)
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean concentrations (GMCs), in microgram per millilitre (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time frame: Prior to (PRE) and one month (Month 1) post booster vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-18C PRE | 0.3 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-6B Month 1 | 1.94 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-1 PRE | 0.14 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-14 Month 1 | 5.56 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-7F PRE | 0.57 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-4 Month 1 | 3.35 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-14 PRE | 0.66 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-7F Month 1 | 3.5 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-23F Month 1 | 2.38 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-9V Month 1 | 3.25 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-9V PRE | 0.54 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-19F Month 1 | 6.05 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-5 PRE | 0.27 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-23F PRE | 0.27 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-19F PRE | 0.53 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-5 Month 1 | 2.2 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-4 PRE | 0.23 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-18C Month 1 | 5.01 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-6B PRE | 0.31 μg/mL |
| Synflorix-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-1 Month 1 | 1.53 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-19F Month 1 | 3.35 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-1 PRE | 0.03 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-1 Month 1 | 0.04 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-4 PRE | 0.3 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-4 Month 1 | 4.4 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-5 PRE | 0.04 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-5 Month 1 | 0.05 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-6B PRE | 0.14 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-6B Month 1 | 3.53 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-7F PRE | 0.03 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-7F Month 1 | 0.04 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-9V PRE | 0.62 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-9V Month 1 | 6.09 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-14 PRE | 1.06 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-14 Month 1 | 9.29 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-18C PRE | 0.32 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-18C Month 1 | 5.21 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-19F PRE | 0.23 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-23F PRE | 0.24 μg/mL |
| Prevenar-Prevenar Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-23F Month 1 | 6.67 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-1 Month 1 | 0.67 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-14 Month 1 | 4.76 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-6B PRE | 0.26 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-23F Month 1 | 2.42 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-18C PRE | 0.37 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-5 Month 1 | 0.74 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-23F PRE | 0.4 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-18C Month 1 | 4.98 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-5 PRE | 0.05 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-1 PRE | 0.03 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-19F PRE | 0.31 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-4 Month 1 | 4.47 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-9V PRE | 0.78 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-7F Month 1 | 1.83 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-4 PRE | 0.35 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-9V Month 1 | 1.94 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-7F PRE | 0.03 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-19F Month 1 | 5.06 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-14 PRE | 1.69 μg/mL |
| Prevenar-Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-6B Month 1 | 1.74 μg/mL |
Secondary
Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA)
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time frame: Prior to (PRE) and one month (Month 1) post booster vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Synflorix Group | Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA) | Anti-PD, PRE | 556.4 EL.U/mL |
| Synflorix-Synflorix Group | Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA) | Anti-PD, Month 1 | 2887.6 EL.U/mL |
| Prevenar-Prevenar Group | Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA) | Anti-PD, PRE | 72.3 EL.U/mL |
| Prevenar-Prevenar Group | Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA) | Anti-PD, Month 1 | 75.3 EL.U/mL |
| Prevenar-Synflorix Group | Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA) | Anti-PD, PRE | 78.1 EL.U/mL |
| Prevenar-Synflorix Group | Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA) | Anti-PD, Month 1 | 125.5 EL.U/mL |
Secondary
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Anti-D and Anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 0.1 IU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time frame: Prior to (PRE) and one month (Month 1) post booster vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Synflorix Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D, PRE | 0.179 EL.U/mL |
| Synflorix-Synflorix Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D, Month 1 | 5.809 EL.U/mL |
| Synflorix-Synflorix Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT, PRE | 0.417 EL.U/mL |
| Synflorix-Synflorix Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT, Month 1 | 9.983 EL.U/mL |
| Prevenar-Prevenar Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT, Month 1 | 4.28 EL.U/mL |
| Prevenar-Prevenar Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D, PRE | 0.291 EL.U/mL |
| Prevenar-Prevenar Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT, PRE | 0.261 EL.U/mL |
| Prevenar-Prevenar Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D, Month 1 | 6.272 EL.U/mL |
| Prevenar-Synflorix Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT, Month 1 | 5.677 EL.U/mL |
| Prevenar-Synflorix Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D, Month 1 | 9.337 EL.U/mL |
| Prevenar-Synflorix Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT, PRE | 0.265 EL.U/mL |
| Prevenar-Synflorix Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D, PRE | 0.29 EL.U/mL |
Secondary
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Anti-HBs antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in milli-International unit per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 10 mIU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time frame: Prior to (PRE) and one month (Month 1) post booster vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Synflorix Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | Anti-HBs, PRE | 147.2 mIU/mL |
| Synflorix-Synflorix Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | Anti-HBs, Month 1 | 3869.1 mIU/mL |
| Prevenar-Prevenar Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | Anti-HBs, PRE | 148.9 mIU/mL |
| Prevenar-Prevenar Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | Anti-HBs, Month 1 | 3132.2 mIU/mL |
| Prevenar-Synflorix Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | Anti-HBs, PRE | 156.6 mIU/mL |
| Prevenar-Synflorix Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | Anti-HBs, Month 1 | 4358.6 mIU/mL |
Secondary
Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Anti-PT, Anti-FHA and Anti-PRN concentrations measured by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 5 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time frame: Prior to (PRE) and one month (Month 1) post booster vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Synflorix Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT, PRE | 5.5 EL.U/mL |
| Synflorix-Synflorix Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT, Month 1 | 79.6 EL.U/mL |
| Synflorix-Synflorix Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA, PRE | 27.1 EL.U/mL |
| Synflorix-Synflorix Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA, Month 1 | 357.7 EL.U/mL |
| Synflorix-Synflorix Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN, PRE | 9.1 EL.U/mL |
| Synflorix-Synflorix Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN, Month 1 | 248.9 EL.U/mL |
| Prevenar-Prevenar Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN, Month 1 | 204.6 EL.U/mL |
| Prevenar-Prevenar Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT, PRE | 7.3 EL.U/mL |
| Prevenar-Prevenar Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA, Month 1 | 334.5 EL.U/mL |
| Prevenar-Prevenar Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN, PRE | 11.1 EL.U/mL |
| Prevenar-Prevenar Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT, Month 1 | 76 EL.U/mL |
| Prevenar-Prevenar Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA, PRE | 29 EL.U/mL |
| Prevenar-Synflorix Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT, Month 1 | 85.8 EL.U/mL |
| Prevenar-Synflorix Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA, PRE | 35.5 EL.U/mL |
| Prevenar-Synflorix Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN, Month 1 | 276.5 EL.U/mL |
| Prevenar-Synflorix Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA, Month 1 | 400.2 EL.U/mL |
| Prevenar-Synflorix Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT, PRE | 7 EL.U/mL |
| Prevenar-Synflorix Group | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN, PRE | 12.1 EL.U/mL |
Secondary
Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers
Anti-Polio 1, 2 and 3 antibody titers were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seroprotection cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time frame: Prior to (PRE) and one month (Month 1) post booster vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Synflorix Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 1, PRE | 25.3 Titers |
| Synflorix-Synflorix Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 1, Month 1 | 904.4 Titers |
| Synflorix-Synflorix Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 2, PRE | 20.8 Titers |
| Synflorix-Synflorix Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 2 , Month 1 | 793.5 Titers |
| Synflorix-Synflorix Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 3, PRE | 33.7 Titers |
| Synflorix-Synflorix Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 3, Month 1 | 1465 Titers |
| Prevenar-Prevenar Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 3, Month 1 | 1191.7 Titers |
| Prevenar-Prevenar Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 1, PRE | 21.2 Titers |
| Prevenar-Prevenar Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 2 , Month 1 | 495.7 Titers |
| Prevenar-Prevenar Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 3, PRE | 25.8 Titers |
| Prevenar-Prevenar Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 1, Month 1 | 819.3 Titers |
| Prevenar-Prevenar Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 2, PRE | 12.9 Titers |
| Prevenar-Synflorix Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 1, Month 1 | 1003.7 Titers |
| Prevenar-Synflorix Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 2, PRE | 17.9 Titers |
| Prevenar-Synflorix Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 3, Month 1 | 1646.5 Titers |
| Prevenar-Synflorix Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 2 , Month 1 | 661.2 Titers |
| Prevenar-Synflorix Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 1, PRE | 27.1 Titers |
| Prevenar-Synflorix Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 3, PRE | 28.2 Titers |
Secondary
Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations
Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off for the assay for the purpose of this endpoint was ≥ 0.15 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time frame: Prior to (PRE) and one month (Month 1) post booster vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Synflorix Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | Anti-PRP, PRE | 0.308 μg/mL |
| Synflorix-Synflorix Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | Anti-PRP, Month 1 | 36.634 μg/mL |
| Prevenar-Prevenar Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | Anti-PRP, PRE | 0.231 μg/mL |
| Prevenar-Prevenar Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | Anti-PRP, Month 1 | 25.731 μg/mL |
| Prevenar-Synflorix Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | Anti-PRP, PRE | 0.246 μg/mL |
| Prevenar-Synflorix Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | Anti-PRP, Month 1 | 29.851 μg/mL |
Secondary
Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens
A BST responder to PT, FHA and PRN antigens was defined as a subject with the appearance of antibodies in subjects who were seronegative prior to the booster vaccination or at least 2-fold increase of pre-booster vaccination antibody concentrations in subjects who were seropositive prior to the booster vaccination. A seropositive/seronegative subject as regards Anti-PT/-FHA/ -PRN antibodies was defined as a subject with anti-PT/-FHA/ -PRN antibody concentrations ≥ 5 Enzyme-linked Immunosorbent assay (ELISA) unit per milli-liter (EL.U/mL)
Time frame: One month (Month 1) post booster vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix-Synflorix Group | Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens | BST responder to FHA antigens | 332 Participants |
| Synflorix-Synflorix Group | Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens | BST responder to PT antigens | 323 Participants |
| Synflorix-Synflorix Group | Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens | BST responder to PRN antigens | 339 Participants |
| Prevenar-Prevenar Group | Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens | BST responder to FHA antigens | 31 Participants |
| Prevenar-Prevenar Group | Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens | BST responder to PT antigens | 31 Participants |
| Prevenar-Prevenar Group | Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens | BST responder to PRN antigens | 30 Participants |
| Prevenar-Synflorix Group | Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens | BST responder to PT antigens | 132 Participants |
| Prevenar-Synflorix Group | Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens | BST responder to PRN antigens | 131 Participants |
| Prevenar-Synflorix Group | Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens | BST responder to FHA antigens | 129 Participants |
Secondary
Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA)
A seroprotected subject as regards anti-pneumococcal serotype antibody was defined as a subject with anti-pneumococcal serotype antibody concentration above than or equal to (≥) 0.20 microgram per millilitre (μg/mL). Anti-pneumococcal serotypes antibodies assessed were antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F). Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using ≥ 0.05 μg/mL as seropositivity cut off. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time frame: Prior to (PRE) and one month after (Month 1) booster vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-4 PRE | 196 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-14 Month 1 | 336 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-6B Month 1 | 329 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-23F Month 1 | 332 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-14 PRE | 268 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-7F PRE | 308 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-19F Month 1 | 341 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-9V Month 1 | 340 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-7F Month 1 | 342 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-4 Month 1 | 342 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-9V PRE | 291 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-1 Month 1 | 340 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-19F PRE | 272 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-5 PRE | 231 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-1 PRE | 123 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-18C Month 1 | 343 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-5 Month 1 | 340 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-23F PRE | 206 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-18C PRE | 240 Participants |
| Synflorix-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-6B PRE | 223 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-19F Month 1 | 87 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-1 PRE | 3 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-1 Month 1 | 4 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-4 PRE | 53 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-4 Month 1 | 88 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-5 PRE | 5 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-5 Month 1 | 5 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-6B PRE | 23 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-6B Month 1 | 85 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-7F PRE | 4 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-7F Month 1 | 6 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-9V PRE | 70 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-9V Month 1 | 89 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-14 PRE | 70 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-14 Month 1 | 86 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-18C Month 1 | 87 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-19F PRE | 38 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-18C PRE | 60 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-23F PRE | 43 Participants |
| Prevenar-Prevenar Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-23F Month 1 | 87 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-6B PRE | 69 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-1 Month 1 | 113 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-14 Month 1 | 133 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-5 Month 1 | 114 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-18C PRE | 107 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-5 PRE | 14 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-23F Month 1 | 128 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-18C Month 1 | 133 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-4 Month 1 | 133 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-23F PRE | 98 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-19F PRE | 76 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-7F Month 1 | 127 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-4 PRE | 99 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-9V PRE | 123 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-7F PRE | 3 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-1 PRE | 3 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-9V Month 1 | 133 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-6B Month 1 | 131 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-19F Month 1 | 131 Participants |
| Prevenar-Synflorix Group | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-14 PRE | 125 Participants |
Secondary
Number of Subjects With Any and Any Grade 3 Solicited General Symptoms
Solicited general symptoms assessed include 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 everyday activities. 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. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.
Time frame: Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Population: The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets..
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Any drowsiness | 303 Participants |
| Synflorix-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 5 Participants |
| Synflorix-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Any fever | 245 Participants |
| Synflorix-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Grade 3 fever | 1 Participants |
| Synflorix-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Any irritability | 438 Participants |
| Synflorix-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Grade 3 irritability | 15 Participants |
| Synflorix-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Any loss of appetite | 230 Participants |
| Synflorix-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 4 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Any fever | 33 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Any loss of appetite | 31 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Grade 3 fever | 2 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Any irritability | 55 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Grade 3 irritability | 2 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Any drowsiness | 48 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 0 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 0 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Any fever | 112 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 5 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Any drowsiness | 130 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Grade 3 fever | 3 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Any loss of appetite | 92 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Grade 3 irritability | 12 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Any irritability | 176 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 3 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.
Time frame: Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Population: The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets..
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix-Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 451 Participants |
| Synflorix-Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 96 Participants |
| Synflorix-Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 67 Participants |
| Synflorix-Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 338 Participants |
| Synflorix-Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 452 Participants |
| Synflorix-Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 47 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 48 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 59 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 3 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 7 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 7 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 42 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 19 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 150 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 18 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 112 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 20 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 153 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) During the Active Phase of the Study
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity . The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007.
Time frame: Throughout the Active Phase of the study, that is, within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Population: The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix-Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) During the Active Phase of the Study | 12 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Serious Adverse Events (SAEs) During the Active Phase of the Study | 1 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) During the Active Phase of the Study | 4 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) During the Entire Study
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects enrolled in the ESFU Phase of the study.
Time frame: Throughout the study period, from Month 0 prior to booster vaccination up to Month 6, end of the ESFU in this study 10PN-PD-DIT-007
Population: The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix-Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) During the Entire Study | 33 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Serious Adverse Events (SAEs) During the Entire Study | 6 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) During the Entire Study | 8 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007.
Time frame: Within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Population: The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix-Synflorix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 188 Participants |
| Prevenar-Prevenar Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 32 Participants |
| Prevenar-Synflorix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 99 Participants |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time frame: Prior to (PRE) and one month (Month 1) post booster vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C PRE | 8.7 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B Month 1 | 981.2 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1 PRE | 6.1 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14 Month 1 | 2085.9 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F PRE | 377.7 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4 Month 1 | 1856.3 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14 PRE | 188.1 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F Month 1 | 4330.3 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F Month 1 | 2830.1 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V Month 1 | 2343.5 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V PRE | 296.9 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F Month 1 | 624.3 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5 PRE | 8.2 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F PRE | 171.5 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F PRE | 10.5 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5 Month 1 | 144.1 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4 PRE | 20.3 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C Month 1 | 810.3 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B PRE | 60.3 Titers |
| Synflorix-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1 Month 1 | 192.2 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F Month 1 | 287.8 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1 PRE | 5 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1 Month 1 | 4.3 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4 PRE | 24.5 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4 Month 1 | 2812.6 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5 PRE | 4.4 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5 Month 1 | 4.1 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B PRE | 51.4 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B Month 1 | 3459.6 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F PRE | 34.8 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F Month 1 | 25.2 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V PRE | 305.5 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V Month 1 | 5357.4 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14 PRE | 201.6 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14 Month 1 | 2134.2 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C PRE | 10.4 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C Month 1 | 968.7 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F PRE | 5.9 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F PRE | 205.8 Titers |
| Prevenar-Prevenar Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F Month 1 | 13900.7 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1 Month 1 | 8.3 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14 Month 1 | 977.8 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B PRE | 36.7 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F Month 1 | 2828.8 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C PRE | 8.5 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5 Month 1 | 9.5 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F PRE | 532.9 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C Month 1 | 610.7 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5 PRE | 4.1 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1 PRE | 4.9 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F PRE | 7.3 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4 Month 1 | 1528.9 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V PRE | 305.1 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F Month 1 | 2397.2 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4 PRE | 37.8 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V Month 1 | 886.8 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F PRE | 25.3 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F Month 1 | 530.1 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14 PRE | 391.1 Titers |
| Prevenar-Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B Month 1 | 640.2 Titers |