Infections, Streptococcal
Conditions
Keywords
Pneumococcal disease, Immunogenicity, Booster vaccination, Pneumococcal vaccine, Primary vaccination, Safety
Brief summary
This study will aim to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of age.
Interventions
BIOLOGICALPneumococcal vaccine GSK1024850A
Intramuscular injection, 4 doses
BIOLOGICALDTPa
Subcutaneous injection, 4 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
90 Days to 118 Days
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator/co-investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol. * A male or female between, and including, 90 and 118 days of age (3 months) at the time of the first vaccination. * Written informed consent obtained from the parent(s)/LAR(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born after a gestation period of 36 to 42 weeks inclusive.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of study vaccine(s) and ending on the last study visit, with the exception of Haemophilus influenzae type b vaccine, Hepatitis B Vaccine, Bacille Calmette-Guérin vaccine, Oral Polio Vaccine, Japanese encephalitis, measles and rubella, varicella, mumps, and flu vaccines. * 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 product (pharmaceutical product or device). * Administration of any pneumococcal vaccine since birth except for the DTPa group for whom vaccination with a licensed pneumococcal vaccine by catch-up schedule will be allowed only if the 2 vaccine doses are administered between Study Visit 4 and 5, i.e. from the second blood sampling timepoint (Visit 4) onwards and up to 7 days before the booster dose of the DTPa vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * History of, or intercurrent diphtheria, tetanus, pertussis disease. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines. * Major congenital defects or serious chronic illness. * History of any seizures or progressive neurological disease. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Child in care. * Acute disease and/or fever at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | 1 month following primary immunization (at Month 3) | Concentrations were expressed as geometric mean concentrations (GMCs). Antibodies assessed for this outcome measure were those against the vaccine 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). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 microgram per milliliter (µg/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | 1 month following primary immunization (at Month 3) | Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. |
| Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization | Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group. |
| Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) | 1 month following primary immunization (at Month 3) | Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. |
| Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization | Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations \< 0.05 g/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group. |
| Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) | 1 month following primary immunization (at Month 3) | Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. |
| Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization | Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group. |
| Concentrations of Antibodies Against Protein D (PD) (Primary Immunization) | 1 month following primary immunization (at Month 3) | 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 \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. |
| Concentrations of Antibodies Against Protein D (PD) (Booster Immunization) | Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization | 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 \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. |
| Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization) | 1 month following primary immunization (at Month 3) | Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. |
| Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Prior to (PRE, at Month 14-16 ) and one month after booster (POST, at Month 15-17) immunization | Antibodies assessed for this outcome measure were those against the vaccine 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). Antibody concentrations were measured by 22F ELISA, expressed as GMCs, in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. Antibody concentrations \< 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group. |
| Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization) | 1 month following primary immunization (at Month 3) | Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL |
| Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) | Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization | Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | During the 8-day (Days 0-7) after each primary vaccine dose | Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | During the 8-day (Days 0-7) period following booster vaccination | Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | During the 8-day (Days 0-7) after each primary vaccine dose | General AEs = drowsiness, fever (axillary ≥ 37.5 degrees Celsius), irritabilityand loss of appetite, vomiting. Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | During the 8-day (Days 0-7) period following booster vaccination | Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Unsolicited AEs After Primary Vaccination | Within the 31-day (Days 0-30) post-primary vaccination period, across doses | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects With Unsolicited AEs After Booster Vaccination | Within the 31-day (Days 0-30) post booster vaccination period | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects With Serious Adverse Events (SAEs) | From study start at Month 0 up to study end at Month 15-17 | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
| Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) | Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization | Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. |
Countries
Japan
Participant flow
Recruitment details
A total of 360 subjects were enrolled in the study. All subjects received at least one vaccination dose.
Participants by arm
| Arm | Count |
|---|---|
| 10Pn Group Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT KAKETSUKEN Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). | 237 |
| DTPa Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT KAKETSUKEN Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis.. | 123 |
| Total | 360 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Booster Vaccination Phase | Migrated/moved from study area | 1 | 0 | 0 | 0 |
| Booster Vaccination Phase | Withdrawal by Subject | 1 | 0 | 0 | 0 |
| Primary Vaccination Phase | Adverse Event | 1 | 0 | 0 | 0 |
| Primary Vaccination Phase | Migrated/moved from study area | 0 | 1 | 0 | 0 |
| Primary Vaccination Phase | Protocol Violation | 1 | 0 | 0 | 0 |
| Primary Vaccination Phase | Serious Adverse Event | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 10Pn Group | DTPa Group | Total |
|---|---|---|---|
| Age, Continuous | 13.6 Weeks STANDARD_DEVIATION 1.02 | 13.5 Weeks STANDARD_DEVIATION 1.1 | 13.57 Weeks STANDARD_DEVIATION 1.05 |
| Sex: Female, Male Female | 117 Participants | 59 Participants | 176 Participants |
| Sex: Female, Male Male | 120 Participants | 64 Participants | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 237 | 0 / 123 |
| other Total, other adverse events | 236 / 237 | 122 / 123 |
| serious Total, serious adverse events | 28 / 237 | 19 / 123 |
Outcome results
Primary
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization)
Concentrations were expressed as geometric mean concentrations (GMCs). Antibodies assessed for this outcome measure were those against the vaccine 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). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 microgram per milliliter (µg/mL).
Time frame: 1 month following primary immunization (at Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after primary vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-1 | 6.52 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-4 | 6.54 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-5 | 6.54 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-6B | 1.71 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-7F | 6.11 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-9V | 5.42 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-14 | 10.03 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-18C | 16.59 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-19F | 17.39 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-23F | 2.17 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-18C | 0.04 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-1 | 0.04 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-9V | 0.03 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-4 | 0.03 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-23F | 0.04 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-5 | 0.05 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-14 | 0.07 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-6B | 0.03 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-19F | 0.06 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) | Anti-7F | 0.03 μg/mL |
Comparison: Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 1.95% CI: [0.14, 0.18]
Comparison: Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 4.95% CI: [0.2, 0.25]
Comparison: Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 5.95% CI: [0.23, 0.29]
Comparison: Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 6B.95% CI: [0.16, 0.23]
Comparison: Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 7F.95% CI: [0.25, 0.31]
Comparison: Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 9V.95% CI: [0.22, 0.27]
Comparison: Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 14.95% CI: [0.25, 0.33]
Comparison: Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 18C.95% CI: [0.09, 0.12]
Comparison: Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 19F.95% CI: [0.09, 0.12]
Comparison: Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 23F.95% CI: [0.21, 0.29]
Secondary
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations \< 0.05 g/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Time frame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Population: The analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component before and after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Anti-6A PRE | 0.61 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Anti-6A POST | 2.72 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Anti-19A PRE | 0.57 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Anti-19A POST | 5.16 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Anti-19A POST | 0.15 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Anti-6A PRE | 0.19 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Anti-19A PRE | 0.12 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Anti-6A POST | 0.21 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Anti-19A POST | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Anti-6A POST | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Anti-19A PRE | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | Anti-6A PRE | 0.03 μg/mL |
Secondary
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: 1 month following primary immunization (at Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after primary vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) | Anti-19A | 0.48 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) | Anti-6A | 0.41 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) | Anti-6A | 0.04 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) | Anti-19A | 0.04 μg/mL |
Secondary
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization)
Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.
Time frame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Population: Analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects with assay results available for antibodies against DT or TT before and after booster vaccination. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) | Anti-DT PRE | 0.615 IU/mL |
| 10Pn Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) | Anti-DT POST | 15.977 IU/mL |
| 10Pn Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) | Anti-TT PRE | 2.043 IU/mL |
| 10Pn Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) | Anti-TT POST | 11.057 IU/mL |
| DTPa Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) | Anti-TT POST | 6.278 IU/mL |
| DTPa Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) | Anti-DT PRE | 0.717 IU/mL |
| DTPa Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) | Anti-TT PRE | 1.352 IU/mL |
| DTPa Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) | Anti-DT POST | 10.814 IU/mL |
Secondary
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization)
Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.
Time frame: 1 month following primary immunization (at Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against Diphtheria Toxoid or Tetanus Toxoid after primary vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization) | Anti-DT | 5.363 IU/mL |
| 10Pn Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization) | Anti-TT | 5.427 IU/mL |
| DTPa Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization) | Anti-DT | 3.829 IU/mL |
| DTPa Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization) | Anti-TT | 3.626 IU/mL |
Secondary
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization)
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL
Time frame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Population: Analysis was performed on the ATPcohort for immunogenicity for booster epoch, which included all evaluable subjects with assay results available for antibodies against PT or FHA before and after booster vaccination. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e. subjects with or without Prevenar vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) | Anti-PT PRE | 14.9 EL.U/mL |
| 10Pn Group | Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) | Anti-PT POST | 158.4 EL.U/mL |
| 10Pn Group | Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) | Anti-FHA PRE | 37.9 EL.U/mL |
| 10Pn Group | Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) | Anti-FHA POST | 460.6 EL.U/mL |
| DTPa Group | Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) | Anti-FHA POST | 584.5 EL.U/mL |
| DTPa Group | Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) | Anti-PT PRE | 18.1 EL.U/mL |
| DTPa Group | Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) | Anti-FHA PRE | 48.4 EL.U/mL |
| DTPa Group | Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) | Anti-PT POST | 204 EL.U/mL |
Secondary
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization)
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL
Time frame: 1 month following primary immunization (at Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against Pertussis or Filamentous haemagglutinin after primary vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization) | Anti-PT | 123.2 EL.U/mL |
| 10Pn Group | Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization) | Anti-FHA | 308.6 EL.U/mL |
| DTPa Group | Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization) | Anti-PT | 133.1 EL.U/mL |
| DTPa Group | Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization) | Anti-FHA | 365 EL.U/mL |
Secondary
Concentrations of Antibodies Against Protein D (PD) (Booster Immunization)
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 \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Population: Analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects with assay results available for antibodies against Protein D before and after booster vaccination. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Concentrations of Antibodies Against Protein D (PD) (Booster Immunization) | Anti-PD PRE | 702.6 EL.U/mL |
| 10Pn Group | Concentrations of Antibodies Against Protein D (PD) (Booster Immunization) | Anti-PD POST | 2916.9 EL.U/mL |
| DTPa Group | Concentrations of Antibodies Against Protein D (PD) (Booster Immunization) | Anti-PD PRE | 82.3 EL.U/mL |
| DTPa Group | Concentrations of Antibodies Against Protein D (PD) (Booster Immunization) | Anti-PD POST | 86.9 EL.U/mL |
Secondary
Concentrations of Antibodies Against Protein D (PD) (Primary Immunization)
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 \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: 1 month following primary immunization (at Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against Protein D after primary vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10Pn Group | Concentrations of Antibodies Against Protein D (PD) (Primary Immunization) | 2548.6 EL.U/mL |
| DTPa Group | Concentrations of Antibodies Against Protein D (PD) (Primary Immunization) | 87.9 EL.U/mL |
Secondary
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization)
Antibodies assessed for this outcome measure were those against the vaccine 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). Antibody concentrations were measured by 22F ELISA, expressed as GMCs, in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. Antibody concentrations \< 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Time frame: Prior to (PRE, at Month 14-16 ) and one month after booster (POST, at Month 15-17) immunization
Population: The analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component before and after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-18C PRE | 2.18 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-6B POST | 3.66 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-1 PRE | 0.8 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-14 POST | 15.72 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-7F PRE | 1.48 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-4 POST | 12.89 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-14 PRE | 2.37 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-7F POST | 10.68 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-23F POST | 7.68 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-9V POST | 12.79 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-9V PRE | 1.81 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-19F POST | 28.72 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-5 PRE | 1.22 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-23F PRE | 1.14 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-19F PRE | 2.92 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-5 POST | 8.81 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-4 PRE | 0.81 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-18C POST | 34.9 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-6B PRE | 0.93 μg/mL |
| 10Pn Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-1 POST | 7.81 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-19F POST | 0.68 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-1 PRE | 0.04 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-1 POST | 0.04 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-4 PRE | 0.85 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-4 POST | 0.78 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-5 PRE | 0.08 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-5 POST | 0.15 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-6B PRE | 0.34 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-6B POST | 0.33 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-7F PRE | 0.05 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-7F POST | 0.09 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-9V PRE | 1.01 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-9V POST | 0.96 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-14 PRE | 3.17 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-14 POST | 2.92 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-18C PRE | 0.94 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-18C POST | 0.77 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-19F PRE | 0.51 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-23F PRE | 0.55 μg/mL |
| DTPa Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-23F POST | 0.88 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-1 POST | 0.24 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-14 POST | 0.16 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-6B PRE | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-23F POST | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-18C PRE | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-5 POST | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-23F PRE | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-18C POST | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-5 PRE | 0.05 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-1 PRE | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-19F PRE | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-4 POST | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-9V PRE | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-7F POST | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-4 PRE | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-9V POST | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-7F PRE | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-19F POST | 0.03 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-14 PRE | 0.09 μg/mL |
| DTPa - no Prevenar Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) | Anti-6B POST | 0.03 μg/mL |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.
Time frame: During the 8-day (Days 0-7) period following booster vaccination
Population: The analysis was performed on the Total Vaccinated cohort for booster epoch, which included all subjects having received the booster dose and who had their symptoms sheet filled in. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | Grade 3 pain | 12 Subjects |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | Redness > 30 mm | 72 Subjects |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | Any pain | 134 Subjects |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | Any swelling | 180 Subjects |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | Any redness | 197 Subjects |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | Swelling > 30 mm | 65 Subjects |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | Any redness | 102 Subjects |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | Any pain | 47 Subjects |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | Grade 3 pain | 0 Subjects |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | Swelling > 30 mm | 18 Subjects |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | Redness > 30 mm | 20 Subjects |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination | Any swelling | 90 Subjects |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.
Time frame: During the 8-day (Days 0-7) after each primary vaccine dose
Population: The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses and who had their symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any pain Dose 1 | 83 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 pain Dose 1 | 1 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any redness Dose 1 | 182 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 Redness Dose 1 | 10 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any swelling Dose 1 | 126 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 Swelling Dose 1 | 16 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any pain Dose 2 | 74 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 pain Dose 2 | 0 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any redness Dose 2 | 200 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 Redness Dose 2 | 25 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any swelling Dose 2 | 160 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 Swelling Dose 2 | 26 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any pain Dose 3 | 63 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 pain Dose 3 | 1 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any redness Dose 3 | 178 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 Redness Dose 3 | 24 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any swelling Dose 3 | 142 Participants |
| 10Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 Swelling Dose 3 | 27 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 pain Dose 3 | 0 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any pain Dose 1 | 19 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 Redness Dose 2 | 4 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 pain Dose 1 | 0 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 Swelling Dose 3 | 1 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any redness Dose 1 | 71 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any swelling Dose 2 | 75 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 Redness Dose 1 | 0 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any redness Dose 3 | 84 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any swelling Dose 1 | 33 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 Swelling Dose 2 | 4 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 Swelling Dose 1 | 0 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any swelling Dose 3 | 65 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any pain Dose 2 | 26 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any pain Dose 3 | 23 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 pain Dose 2 | 0 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Grade 3 Redness Dose 3 | 0 Participants |
| DTPa Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination | Any redness Dose 2 | 96 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination
Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 8-day (Days 0-7) period following booster vaccination
Population: The analysis was performed on the Total Vaccinated cohort for booster epoch, which included all subjects having received the booster dose and who had their symptoms sheet filled in. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Any drowsiness | 69 Subjects |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Grade 3 drowsiness | 3 Subjects |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Related drowsiness | 19 Subjects |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Fever >= 37.5°C | 90 Subjects |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Fever > 39.5°C | 6 Subjects |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Related fever | 41 Subjects |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Any irritability | 90 Subjects |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Grade 3 irritability | 8 Subjects |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Related irritability | 36 Subjects |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Any loss of appetite | 48 Subjects |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Grade 3 loss of appetite | 4 Subjects |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Related loss of appetite | 12 Subjects |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Grade 3 loss of appetite | 1 Subjects |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Any drowsiness | 30 Subjects |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Any irritability | 35 Subjects |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Grade 3 drowsiness | 3 Subjects |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Any loss of appetite | 17 Subjects |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Related drowsiness | 7 Subjects |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Grade 3 irritability | 2 Subjects |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Fever >= 37.5°C | 24 Subjects |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Related loss of appetite | 2 Subjects |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Fever > 39.5°C | 0 Subjects |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Related irritability | 10 Subjects |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination | Related fever | 11 Subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination
General AEs = drowsiness, fever (axillary ≥ 37.5 degrees Celsius), irritabilityand loss of appetite, vomiting. Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 8-day (Days 0-7) after each primary vaccine dose
Population: The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses and who had their symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any irritability Dose 2 | 88 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related fever Dose 1 | 20 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 irritability Dose 2 | 4 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 loss of appetite Dose 1 | 0 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related irritability Dose 2 | 30 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any Fever Dose 1 | 61 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any loss of appetite Dose 2 | 27 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related loss of appetite Dose 1 | 4 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 loss of appetite Dose 2 | 0 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any irritability Dose 1 | 100 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related loss of appetite Dose 2 | 7 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any drowsiness Dose 2 | 67 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any drowsiness Dose 3 | 41 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related drowsiness Dose 1 | 24 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 drowsiness Dose 3 | 0 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 drowsiness Dose 2 | 2 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related drowsiness Dose 3 | 15 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 irritability Dose 1 | 6 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any Fever Dose 3 | 51 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related drowsiness Dose 2 | 26 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 Fever Dose 3 | 2 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 Fever Dose 1 | 1 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related fever Dose 3 | 21 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any Fever Dose 2 | 65 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any irritability Dose 3 | 80 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related irritability Dose 1 | 40 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 irritability Dose 3 | 3 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 Fever Dose 2 | 0 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related irritability Dose 3 | 31 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 drowsiness Dose 1 | 3 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any loss of appetite Dose 3 | 25 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related fever Dose 2 | 31 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 loss of appetite Dose 3 | 0 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any loss of appetite Dose 1 | 32 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related loss of appetite Dose 3 | 5 Participants |
| 10Pn Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any drowsiness Dose 1 | 67 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related loss of appetite Dose 3 | 0 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any drowsiness Dose 1 | 24 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 drowsiness Dose 1 | 0 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related drowsiness Dose 1 | 6 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any Fever Dose 1 | 20 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 Fever Dose 1 | 0 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related fever Dose 1 | 5 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any irritability Dose 1 | 43 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 irritability Dose 1 | 3 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related irritability Dose 1 | 12 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any loss of appetite Dose 1 | 12 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 loss of appetite Dose 1 | 0 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related loss of appetite Dose 1 | 1 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any drowsiness Dose 2 | 34 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 drowsiness Dose 2 | 0 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related drowsiness Dose 2 | 9 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any Fever Dose 2 | 22 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 Fever Dose 2 | 0 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related fever Dose 2 | 7 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any irritability Dose 2 | 45 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 irritability Dose 2 | 0 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related irritability Dose 2 | 12 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any loss of appetite Dose 2 | 7 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 loss of appetite Dose 2 | 0 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related loss of appetite Dose 2 | 2 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any drowsiness Dose 3 | 25 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 drowsiness Dose 3 | 0 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related drowsiness Dose 3 | 10 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any Fever Dose 3 | 21 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 Fever Dose 3 | 0 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related fever Dose 3 | 2 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any irritability Dose 3 | 31 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 irritability Dose 3 | 0 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Related irritability Dose 3 | 10 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Any loss of appetite Dose 3 | 7 Participants |
| DTPa Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination | Grade 3 loss of appetite Dose 3 | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: From study start at Month 0 up to study end at Month 15-17
Population: The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10Pn Group | Number of Subjects With Serious Adverse Events (SAEs) | 28 Participants |
| DTPa Group | Number of Subjects With Serious Adverse Events (SAEs) | 19 Participants |
Secondary
Number of Subjects With Unsolicited AEs After Booster Vaccination
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within the 31-day (Days 0-30) post booster vaccination period
Population: The analysis was performed on the Total Vaccinated cohort for booster epoch, which included all subjects having received the booster dose. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10Pn Group | Number of Subjects With Unsolicited AEs After Booster Vaccination | 132 Subjects |
| DTPa Group | Number of Subjects With Unsolicited AEs After Booster Vaccination | 66 Subjects |
Secondary
Number of Subjects With Unsolicited AEs After Primary Vaccination
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within the 31-day (Days 0-30) post-primary vaccination period, across doses
Population: The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10Pn Group | Number of Subjects With Unsolicited AEs After Primary Vaccination | 193 Subjects |
| DTPa Group | Number of Subjects With Unsolicited AEs After Primary Vaccination | 97 Subjects |
Secondary
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Time frame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Population: The analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component before and after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | OPSONO-6A PRE | 138.5 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | OPSONO-6A POST | 767.9 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | OPSONO-19A PRE | 13.1 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | OPSONO-19A POST | 431.4 Titers |
| DTPa Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | OPSONO-19A POST | 8.6 Titers |
| DTPa Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | OPSONO-6A PRE | 60.4 Titers |
| DTPa Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | OPSONO-19A PRE | 7.7 Titers |
| DTPa Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | OPSONO-6A POST | 103.3 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | OPSONO-19A POST | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | OPSONO-6A POST | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | OPSONO-19A PRE | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) | OPSONO-6A PRE | 4 Titers |
Secondary
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Time frame: 1 month following primary immunization (at Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after primary vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) | Opsono-6A | 339.6 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) | Opsono-19A | 34.3 Titers |
| DTPa Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) | Opsono-6A | 4.6 Titers |
| DTPa Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) | Opsono-19A | 4.3 Titers |
Secondary
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization)
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Time frame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Population: The analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component before and after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-18C PRE | 26.3 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-6B POST | 1682.9 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-1 POST | 2320.7 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-14 POST | 6209 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-7F PRE | 2244.8 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-4 POST | 3863.1 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-14 PRE | 673.1 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-7F POST | 14144.3 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-1 PRE | 45.9 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-9V POST | 4693.7 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-9V PRE | 520 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-19F POST | 3496.3 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-5 PRE | 22.9 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-23F PRE | 600.5 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-19F PRE | 83.4 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-5 POST | 686.7 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-4 PRE | 58.3 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-18C POST | 2181 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-6B PRE | 191.2 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-23F POST | 7057.2 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-19F POST | 20.9 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-1 PRE | 4.5 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-1 POST | 4.7 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-4 PRE | 79 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-4 POST | 69.3 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-5 PRE | 4.2 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-5 POST | 4.7 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-6B PRE | 118.5 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-6B POST | 119 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-7F PRE | 1014.7 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-7F POST | 1165.6 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-9V PRE | 1081.6 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-9V POST | 958.8 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-14 PRE | 826.7 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-14 POST | 819.1 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-18C PRE | 11.5 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-18C POST | 12.7 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-19F PRE | 21.1 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-23F PRE | 1048 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-23F POST | 1758.3 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-1 POST | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-14 POST | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-6B PRE | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-23F POST | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-18C PRE | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-5 POST | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-23F PRE | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-18C POST | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-5 PRE | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-1 PRE | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-19F PRE | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-4 POST | 493 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-9V PRE | 4595 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-7F POST | 1278 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-4 PRE | 371 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-9V POST | 367 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-7F PRE | 588 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-19F POST | 191 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-14 PRE | 4 Titers |
| DTPa - no Prevenar Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) | OPSONO-6B POST | 4 Titers |
Secondary
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization)
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Time frame: 1 month following primary immunization (at Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after primary vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-1 | 619.8 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-4 | 1184.6 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-5 | 335.1 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-6B | 1926.6 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-7F | 7905.9 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-9V | 4063.4 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-14 | 3392.4 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-18C | 893.2 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-19F | 1254.6 Titers |
| 10Pn Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-23F | 4312.1 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-18C | 4.8 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-1 | 4.8 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-9V | 4.9 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-4 | 4.1 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-23F | 6 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-5 | 4.2 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-14 | 6.5 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-6B | 5 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-19F | 4.4 Titers |
| DTPa Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) | OPSONO-7F | 69.5 Titers |