Infections, Streptococcal
Conditions
Keywords
Invasive disease by Streptococcus pneumoniae (S. pneumoniae) (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media), Infants, Multidose, Haemophilus influenzae, Streptococcus pneumoniae, Preservative, Safety, Pneumonia, Immunogenicity, Pneumococcal conjugate vaccine, Acute otitis media caused by non-typeable Haemophilus influenzae (NTHi)., Respiratory tract infections
Brief summary
The primary aim of the study is to demonstrate that an investigational 4-dose presentation of the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of Synflorix (preservative-free) in terms of immune responses to the 10 vaccine pneumococcal serotypes (primary objective) and to the vaccine-related pneumococcal serotype 19A (first secondary objective), after administration of a 3-dose primary vaccination course at 6, 10 and 18 weeks of age co-administered with the first 2 doses of DTPw-HBV/Hib vaccine given at 6, 10 and 14 weeks of age (according to the Expanded Program on Immunization (EPI) schedule). In addition, the study will also assess the safety, reactogenicity, immunogenicity and antibody persistence (approximately 7 months following primary vaccination) of the 4-dose presentation of the 10Pn-PD-DiT vaccine given as primary vaccination schedule at 6, 10 and 18 weeks of age followed by a booster dose at 38 weeks. This study also aims at assessing the safety, reactogenicity and immunogenicity of the 4-dose presentation of the 10Pn-PD-DiT vaccine when given as a booster dose at approximately 9 months of age.
Interventions
BIOLOGICALPneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation)
4 doses by intramuscular injection in the right left anterolateral thigh
BIOLOGICALPneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation)
4 doses by intramuscular injection in the right anterolateral thigh
BIOLOGICALDTPw-HBV/Hib
3 doses by intramuscular injection in the left anterolateral thigh
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 76 Days
Healthy volunteers
Yes
Inclusion criteria
* Subjects for whom, in the opinion of the investigator, the parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol (e.g., return for vaccination and follow-up visits). * A male or female between, and including 6-10 weeks (42-76 days) of age at the time of the first vaccination. * Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the subject. For all subjects, the consent form should be countersigned by a witness. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born full-term (i.e., after a gestation period from 37 to 42 weeks).
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. Inhaled and topical steroids are allowed. * Planned administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab). * Administration or planned administration of a vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of study vaccines and ending 30 days after with the following exceptions: * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product * Previous vaccination against diphtheria, tetanus, pertussis, H. influenzae type b and/or S. pneumoniae. * History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, and H. influenzae type b disease. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * History of any neurological disorders or seizures. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary. * Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed). * Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine | Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for the 10 vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, 19 A ,-19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | At study Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. |
| Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001) | At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine | Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL. |
| Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002) | At study Month 9, e.g.: at one month post booster vaccination with pneumococcal vaccine | Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine | Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age. Dose 4 = 10Pn-PD-DIT at 18 weeks of age. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Within the 4-day (Days 0-3) period after booster vaccination | Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). |
| Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | At Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine | Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. |
| Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Within the 4-day (Days 0-3) period after booster vaccination | Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than \[≥\] 37.5 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (Axillary) temperature higher than (\>) 39.5°C. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001) | Within the 31-day (Days 0-30) period post primary vaccination, across doses | An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002) | Within the 31-day (Days 0-30) period post booster vaccination | An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. |
| Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001) | From Month 0 to Month 4 | An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination. |
| Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study | From Day 0 to Month 9 | An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination. |
| Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine | Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than \[≥\] 37.5 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (\>) 39.5°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age. Dose 4 = 10Pn-PD-DIT at 18 weeks of age. |
Countries
Bangladesh
Participant flow
Recruitment details
Two epochs were defined in the study. The duration of the study was for Epoch 001: Primary starting at Month 0 and ending at Month 4 and for Epoch 002: Booster starting at Month 8 and ending at Month 9. 5 subjects did not participate to the Epoch 002 (none due to an serious adverse event)
Participants by arm
| Arm | Count |
|---|---|
| 10Pn_4d Group Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch 002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine : right thigh; DTPw-HBV/Hibvaccine : left thigh). | 160 |
| Synflorix Group Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of Synflorix™ vaccine at approximatively 9 months of age (Epoch 002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine : right thigh; DTPw-HBV/Hibvaccine : left thigh). | 160 |
| Total | 320 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Epoch 001 | Adverse Event | 1 | 1 |
| Epoch 001 | Lost to Follow-up | 1 | 3 |
| Epoch 001 | Migrated/moved from study area | 3 | 5 |
| Epoch 001 | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | 10Pn_4d Group | Synflorix Group | Total |
|---|---|---|---|
| Age, Continuous | 6.9 Weeks STANDARD_DEVIATION 1.3 | 6.8 Weeks STANDARD_DEVIATION 1.2 | 6.8 Weeks STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized Asian-South East Asian heritage | 160 Participants | 160 Participants | 320 Participants |
| Sex: Female, Male Female | 80 Participants | 73 Participants | 153 Participants |
| Sex: Female, Male Male | 80 Participants | 87 Participants | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 160 | 1 / 160 |
| other Total, other adverse events | 120 / 160 | 126 / 160 |
| serious Total, serious adverse events | 4 / 160 | 9 / 160 |
Outcome results
Primary
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001)
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for the 10 vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine
Population: The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-1 | 2.78 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-4 | 4.23 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-5 | 5.12 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-6B | 1.23 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-7F | 5.52 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-9V | 4.60 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-14 | 4.97 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-18C | 19.58 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-19F | 13.24 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-23F | 1.59 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-6A | 0.31 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-19A | 0.76 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-6A | 0.29 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-1 | 3.03 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-14 | 4.84 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-4 | 3.87 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-23F | 2.04 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-5 | 5.30 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-18C | 21.18 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-6B | 1.37 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-19A | 0.68 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-7F | 5.79 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-19F | 13.11 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | ANTI-9V | 4.07 µg/mL |
Comparison: (Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-1 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.95% CI: [0.89, 1.33]
Comparison: (Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-4 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.95% CI: [0.75, 1.12]
Comparison: (Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-5 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.95% CI: [0.85, 1.26]
Comparison: (Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-6B serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.95% CI: [0.78, 1.61]
Comparison: (Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-7F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.95% CI: [0.88, 1.25]
Comparison: (Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-9V serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.95% CI: [0.69, 1.13]
Comparison: (Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-14 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.95% CI: [0.73, 1.31]
Comparison: (Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-18C serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.95% CI: [0.86, 1.37]
Comparison: (Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-19F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.95% CI: [0.78, 1.25]
Comparison: (Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-23F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.95% CI: [0.92, 1.8]
Secondary
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002)
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.
Time frame: At Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine
Population: The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-6B Month 8 | 1.14 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-1 Month 9 | 6.37 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-4 Month 8 | 1.9 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-4 Month 9 | 9.68 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-5 Month 8 | 1.75 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-5 Month 9 | 11.53 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-1 Month 8 | 0.93 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-6B Month 9 | 3.76 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-7F Month 8 | 2.86 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-7F Month 9 | 12.84 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-9V Month 8 | 2.32 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-9V Month 9 | 12.07 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-14 Month 8 | 2.98 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-14 Month 9 | 9.84 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-18C Month 8 | 8.37 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-18C Month 9 | 41.64 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-19F Month 8 | 6.36 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-19F Month 9 | 23.43 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-23F Month 8 | 1.09 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-23F Month 9 | 6.69 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-6A Month 8 | 0.31 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-6A Month 9 | 0.97 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-19A Month 8 | 0.7 µg/mL |
| 10Pn_4d Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-19A Month 9 | 3.03 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-19A Month 8 | 0.69 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-1 Month 8 | 0.99 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-14 Month 8 | 2.4 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-1 Month 9 | 7.5 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-23F Month 8 | 1.21 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-4 Month 8 | 1.71 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-14 Month 9 | 9.72 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-4 Month 9 | 9.41 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-6A Month 9 | 1.11 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-5 Month 8 | 1.75 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-18C Month 8 | 9.23 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-5 Month 9 | 12.24 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-23F Month 9 | 6.69 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-6B Month 8 | 1.06 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-18C Month 9 | 47.06 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-6B Month 9 | 4.11 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-19A Month 9 | 3.63 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-7F Month 8 | 2.75 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-19F Month 8 | 6.45 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-7F Month 9 | 13.71 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-6A Month 8 | 0.3 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-9V Month 8 | 2.25 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-19F Month 9 | 24.96 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | ANTI-9V Month 9 | 12.43 µg/mL |
Secondary
Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001)
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.
Time frame: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine
Population: The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10Pn_4d Group | Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001) | 2410.5 EL.U/mL |
| Synflorix Group | Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001) | 2495.4 EL.U/mL |
Secondary
Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002)
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.
Time frame: At study Month 9, e.g.: at one month post booster vaccination with pneumococcal vaccine
Population: The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10Pn_4d Group | Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002) | 2672.4 EL.U/mL |
| Synflorix Group | Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002) | 2944 EL.U/mL |
Secondary
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001)
Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than \[≥\] 37.5 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (\>) 39.5°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age. Dose 4 = 10Pn-PD-DIT at 18 weeks of age.
Time frame: Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine
Population: The analysis was performed on the Total vaccinated cohort of Epoch 001 included all subjects who had received at least one dose of primary vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Loss Appetite, post Dose 2 | 24 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Irritability/Fussiness, post Dose 1 | 61 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Loss Appetite, post Dose 2 | 3 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Fever, post Dose 1 | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Loss Appetite, post Dose 2 | 23 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Irritability/Fussiness, post Dose 1 | 61 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Fever, post Dose 2 | 23 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Fever, post Dose 1 | 28 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Fever, post Dose 2 | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Loss Appetite, post Dose 1 | 43 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Fever, post Dose 2 | 22 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Drowsiness, post Dose 2 | 15 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Drowsiness, post Dose 4 | 6 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Drowsiness, post Dose 1 | 26 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Drowsiness, post Dose 4 | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Drowsiness, post Dose 2 | 1 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Drowsiness, post Dose 4 | 6 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Loss Appetite, post Dose 1 | 4 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Irritability/Fussiness, post Dose 4 | 10 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Drowsiness, post Dose 2 | 15 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Irritability/Fussiness, post Dose 4 | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Irritability/Fussiness, post Dose 1 | 14 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Irritability/Fussiness, post Dose 4 | 10 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Irritability/Fussiness, post Dose 2 | 39 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Loss Appetite, post Dose 4 | 5 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Loss Appetite, post Dose 1 | 43 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Loss Appetite, post Dose 4 | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Irritability/Fussiness, post D2 | 4 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Loss Appetite, post Dose 4 | 5 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Drowsiness, post Dose 1 | 1 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Fever, post Dose 4 | 2 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Irritability/Fussiness, post Dose 2 | 39 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Fever, post Dose 4 | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Fever, post Dose 1 | 28 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Fever, post Dose 4 | 2 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Drowsiness, post Dose 1 | 26 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Fever, post Dose 4 | 6 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Drowsiness, post Dose 1 | 31 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Drowsiness, post Dose 1 | 5 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Drowsiness, post Dose 1 | 29 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Irritability/Fussiness, post Dose 1 | 62 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Irritability/Fussiness, post Dose 1 | 8 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Irritability/Fussiness, post Dose 1 | 62 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Loss Appetite, post Dose 1 | 46 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Loss Appetite, post Dose 1 | 3 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Loss Appetite, post Dose 1 | 46 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Fever, post Dose 1 | 30 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Fever, post Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Fever, post Dose 1 | 30 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Drowsiness, post Dose 2 | 23 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Drowsiness, post Dose 2 | 1 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Drowsiness, post Dose 2 | 23 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Irritability/Fussiness, post Dose 2 | 47 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Irritability/Fussiness, post D2 | 5 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Irritability/Fussiness, post Dose 2 | 47 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Loss Appetite, post Dose 2 | 20 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Loss Appetite, post Dose 2 | 2 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Loss Appetite, post Dose 2 | 20 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Fever, post Dose 2 | 18 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Fever, post Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Fever, post Dose 2 | 18 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Drowsiness, post Dose 4 | 8 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Drowsiness, post Dose 4 | 1 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Drowsiness, post Dose 4 | 8 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Irritability/Fussiness, post Dose 4 | 12 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Irritability/Fussiness, post Dose 4 | 1 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Irritability/Fussiness, post Dose 4 | 12 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Loss Appetite, post Dose 4 | 5 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Loss Appetite, post Dose 4 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Related Loss Appetite, post Dose 4 | 5 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Any Fever, post Dose 4 | 6 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Grade 3 Fever, post Dose 4 | 0 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002)
Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than \[≥\] 37.5 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (Axillary) temperature higher than (\>) 39.5°C.
Time frame: Within the 4-day (Days 0-3) period after booster vaccination
Population: The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Related Irritability/Fussiness | 11 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Grade 3 Fever | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Grade 3 Loss Appetite | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Related Fever | 4 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Grade 3 Irritability/Fusiness | 1 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Any Drowsiness | 8 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Related Loss Appetite | 8 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Grade 3 Drowsiness | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Any Loss Appetite | 8 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Related Drowsiness | 8 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Any Fever | 4 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Any Irritability/Fussiness | 11 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Any Fever | 3 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Grade 3 Irritability/Fusiness | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Related Irritability/Fussiness | 5 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Any Loss Appetite | 4 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Grade 3 Loss Appetite | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Related Loss Appetite | 4 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Any Irritability/Fussiness | 5 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Grade 3 Fever | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Related Fever | 3 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Any Drowsiness | 4 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Grade 3 Drowsiness | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Related Drowsiness | 4 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001)
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age. Dose 4 = 10Pn-PD-DIT at 18 weeks of age.
Time frame: Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine
Population: The analysis was performed on the Total vaccinated cohort of Epoch 001 included all subjects who had received at least one dose of primary vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Pain, post Dose 1 | 82 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Pain, post Dose 1 | 4 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Redness, post Dose 1 | 24 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Redness, post Dose 1 | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Swelling, post Dose 1 | 63 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Swelling, post Dose 1 | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Pain, post Dose 2 | 56 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Pain, post Dose 2 | 1 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Redness, post Dose 2 | 22 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Redness, post Dose 2 | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Swelling, post Dose 2 | 31 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Swelling, post Dose 2 | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Pain, post Dose 4 | 13 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Pain, post Dose 4 | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Redness, post Dose 4 | 9 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Redness, post Dose 4 | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Swelling, post Dose 4 | 11 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Swelling, post Dose 4 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Pain, post Dose 4 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Pain, post Dose 1 | 90 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Redness, post Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Pain, post Dose 1 | 5 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Swelling, post Dose 4 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Redness, post Dose 1 | 26 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Swelling, post Dose 2 | 37 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Redness, post Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Redness, post Dose 4 | 8 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Swelling, post Dose 1 | 64 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Swelling, post Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Swelling, post Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Swelling, post Dose 4 | 9 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Pain, post Dose 2 | 56 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Pain, post Dose 4 | 15 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Pain, post Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Grade 3 Redness, post Dose 4 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Any Redness, post Dose 2 | 26 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002)
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm).
Time frame: Within the 4-day (Days 0-3) period after booster vaccination
Population: The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Any Pain | 9 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Grade 3 Pain | 1 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Any Redness | 14 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Grade 3 Redness | 0 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Any Swelling | 16 Participants |
| 10Pn_4d Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Grade 3 Swelling | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Any Swelling | 8 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Any Pain | 2 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Grade 3 Redness | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Grade 3 Pain | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Grade 3 Swelling | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Any Redness | 5 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study
An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.
Time frame: From Day 0 to Month 9
Population: The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10Pn_4d Group | Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study | 4 Participants |
| Synflorix Group | Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study | 9 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001)
An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.
Time frame: From Month 0 to Month 4
Population: The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10Pn_4d Group | Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001) | 4 Participants |
| Synflorix Group | Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001) | 9 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001)
An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
Time frame: Within the 31-day (Days 0-30) period post primary vaccination, across doses
Population: The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10Pn_4d Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001) | 10 Participants |
| Synflorix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001) | 16 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002)
An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
Time frame: Within the 31-day (Days 0-30) period post booster vaccination
Population: The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10Pn_4d Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002) | 0 Participants |
| Synflorix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002) | 0 Participants |
Secondary
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001)
Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, 19 A ,-19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.
Time frame: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine
Population: The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-1 | 48.3 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-4 | 823.1 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-5 | 179.0 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-6B | 560.6 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-7F | 2044.0 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-9V | 613.3 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-14 | 1563.9 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-18C | 3965.4 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-19F | 2151.3 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-23F | 524.8 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-6A | 50.3 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-19A | 98.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-6A | 68.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-1 | 52.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-14 | 1655.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-4 | 836.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-23F | 730.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-5 | 211.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-18C | 3809.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-6B | 759.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-19A | 117.1 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-7F | 2076.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-19F | 2879.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | OPA-9V | 821.1 Titers |
Secondary
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002)
Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.
Time frame: At study Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine
Population: The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-6B Month 8 | 290.3 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-1 Month 9 | 227.7 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-4 Month 8 | 248.1 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-4 Month 9 | 2025.4 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-5 Month 8 | 51.3 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-5 Month 9 | 550.6 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-1 Month 8 | 11.5 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-6B Month 9 | 851.3 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-7F Month 8 | 1112.8 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-7F Month 9 | 4574.7 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-9V Month 8 | 415.8 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-9V Month 9 | 2308.4 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-14 Month 8 | 660.1 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-14 Month 9 | 3345.6 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-18C Month 8 | 1505.4 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-18C Month 9 | 7316.1 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-19F Month 8 | 770.1 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-19F Month 9 | 3197.3 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-23F Month 8 | 267.7 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-23F Month 9 | 1250.8 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-6A Month 8 | 52.4 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-6A Month 9 | 192 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-19A Month 8 | 42.7 Titers |
| 10Pn_4d Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-19A Month 9 | 410.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-19A Month 8 | 43.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-1 Month 8 | 12.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-14 Month 8 | 745 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-1 Month 9 | 326.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-23F Month 8 | 252.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-4 Month 8 | 280.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-14 Month 9 | 3649.1 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-4 Month 9 | 2888.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-6A Month 9 | 284.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-5 Month 8 | 62.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-18C Month 8 | 1735.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-5 Month 9 | 801.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-23F Month 9 | 1465.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-6B Month 8 | 286.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-18C Month 9 | 7181.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-6B Month 9 | 1352 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-19A Month 9 | 591.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-7F Month 8 | 1181.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-19F Month 8 | 1254.3 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-7F Month 9 | 5635.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-6A Month 8 | 45.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-9V Month 8 | 570.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-19F Month 9 | 4757.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | OPA-9V Month 9 | 3181.9 Titers |