Infections, Streptococcal
Conditions
Keywords
Streptococcus pneumoniae, pneumococcal conjugate vaccine
Brief summary
The purposes of this study are: To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™ when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during the first 6 months of life. To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A.
Detailed description
Vaccination course at 2, 4, 6 months of age.
Interventions
BIOLOGICALPneumococcal vaccine GSK1024850A (Synflorix)
3 doses administered intramuscularly.
BIOLOGICALPrevenar
3 doses administered intramuscularly.
BIOLOGICALGSK Biologicals' Hiberix™
3 doses administered intramuscularly.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination. * Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study. * Written and signed informed consent obtained from the parent(s)/guardian(s) of the child/ward. * Free of any known or suspected health problems as established by medical history and clinical examination before entering into the study. * Born after a gestation period of 36 to 42 weeks inclusive, with a birth weight of at least 2.5 kilogram.
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 the study vaccines, or planned use during the study period. * 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). * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Planned administration/administration of a vaccine not allowed by the study protocol during the study period. Vaccines included in the Korean routine immunization schedule can be administered at least one week before or at least one month after the administration of the study vaccines. Recommended live vaccines not included in the Korean routine immunization schedule can be given at least one month before or at least one month after the administration of the study vaccines. * A family history of congenital or hereditary immunodeficiency. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed). * Previous vaccination against Streptococcus pneumoniae and/or Haemophilus influenzae type b. * History of, or intercurrent Streptococcus pneumoniae and/or Haemophilus influenzae type b disease. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of any neurological disorders or seizures. * Major congenital defects or serious chronic illness. * Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | One month after administration of 3rd dose of the pneumococcal conjugate vaccine | Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was \>= 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
| Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). Pneumococcal cross-reactive serotypes were 6A and 19A. |
| Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. |
| Anti-PD Antibody Concentration | One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine | Concentration of anti-PD antibody given as GMC expressed in EL.U/mL. |
| Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL. |
| Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as \>= 8. |
| Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations \>= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL. Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations \>= 0.05 ug/mL. |
| Number of Subjects With Seroprotection Status Against PRP | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL |
| Number of Subjects Reporting Solicited Local Symptoms | Within 4 days after each vaccination | Solicited local symptoms assessed include pain, redness and swelling. |
| Number of Subjects With Solicited General Symptoms | Within 4 days after each vaccination | Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature \>= 37.5 degrees Celsius. |
| Number of Subjects Reporting Unsolicited Adverse Events | Within 31 days after each vaccination | — |
| Number of Subjects With Serious Adverse Events (SAE) | Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5 | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
| Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | Concentration of anti-PRP antibody given as GMC in ug/mL. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Synflorix Group Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4 | 374 |
| Prevenar Group Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4 | 129 |
| Total | 503 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consent withdrawal | 6 | 3 |
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | serious adverse event (SAE) | 0 | 1 |
Baseline characteristics
| Characteristic | Prevenar Group | Total | Synflorix Group |
|---|---|---|---|
| Age, Continuous | 9.5 years STANDARD_DEVIATION 1.43 | 9.5 years STANDARD_DEVIATION 1.47 | 9.5 years STANDARD_DEVIATION 1.49 |
| Region of Enrollment East Asia | 129 participants | 502 participants 0 | 373 participants |
| Region of Enrollment Southeast Asia | 0 participants | 1 participants 0 | 1 participants |
| Sex: Female, Male Female | 71 Participants | 260 Participants | 189 Participants |
| Sex: Female, Male Male | 58 Participants | 243 Participants | 185 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 357 / 374 | 124 / 129 |
| serious Total, serious adverse events | 56 / 374 | 9 / 129 |
Outcome results
Primary
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value
Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: One month after administration of 3rd dose of the pneumococcal conjugate vaccine
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-1 | 344 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-4 | 343 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-6B | 318 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-5 | 344 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-7F | 344 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-9V | 343 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-14 | 342 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-18C | 343 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-19F | 340 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-23F | 331 subjects |
| Prevenar Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-18C | 123 subjects |
| Prevenar Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-1 | 7 subjects |
| Prevenar Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-9V | 122 subjects |
| Prevenar Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-4 | 123 subjects |
| Prevenar Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-23F | 121 subjects |
| Prevenar Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-6B | 121 subjects |
| Prevenar Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-14 | 123 subjects |
| Prevenar Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-5 | 18 subjects |
| Prevenar Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-19F | 123 subjects |
| Prevenar Group | Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value | Anti-7F | 4 subjects |
Secondary
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine
Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-19F | 7.41 ug/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-4 | 4.00 ug/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-5 | 4.52 ug/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-6B | 1.40 ug/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-23F | 1.96 ug/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-7F | 4.08 ug/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-9V | 3.39 ug/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-14 | 5.54 ug/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-18C | 5.80 ug/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-1 | 3.41 ug/mL |
| Prevenar Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-18C | 5.13 ug/mL |
| Prevenar Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-1 | 0.04 ug/mL |
| Prevenar Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-23F | 3.94 ug/mL |
| Prevenar Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-4 | 5.35 ug/mL |
| Prevenar Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-9V | 5.09 ug/mL |
| Prevenar Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-5 | 0.07 ug/mL |
| Prevenar Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-7F | 0.03 ug/mL |
| Prevenar Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-6B | 2.07 ug/mL |
| Prevenar Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-14 | 8.51 ug/mL |
| Prevenar Group | Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Anti-19F | 2.77 ug/mL |
Secondary
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes
Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes | Anti-6A | 0.38 ug/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes | Anti-19A | 0.29 ug/mL |
| Prevenar Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes | Anti-6A | 0.48 ug/mL |
| Prevenar Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes | Anti-19A | 0.12 ug/mL |
Secondary
Anti-PD Antibody Concentration
Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.
Time frame: One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix Group | Anti-PD Antibody Concentration | 1622.4 EL.U/mL |
| Prevenar Group | Anti-PD Antibody Concentration | 88.2 EL.U/mL |
Secondary
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations
Concentration of anti-PRP antibody given as GMC in ug/mL.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix Group | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations | 20.131 ug/mL |
| Prevenar Group | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations | 11.844 ug/mL |
Secondary
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Time frame: Within 4 days after each vaccination
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 210 subjects |
| Synflorix Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 252 subjects |
| Synflorix Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 182 subjects |
| Prevenar Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 72 subjects |
| Prevenar Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 84 subjects |
| Prevenar Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 69 subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: Within 31 days after each vaccination
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects Reporting Unsolicited Adverse Events | 213 subjects |
| Prevenar Group | Number of Subjects Reporting Unsolicited Adverse Events | 62 subjects |
Secondary
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes
Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations \>= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL. Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations \>= 0.05 ug/mL.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-23F | 340 subjects |
| Synflorix Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-4 | 344 subjects |
| Synflorix Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-7F | 344 subjects |
| Synflorix Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-5 | 344 subjects |
| Synflorix Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-9V | 343 subjects |
| Synflorix Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-PD | 343 subjects |
| Synflorix Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-14 | 344 subjects |
| Synflorix Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-6B | 337 subjects |
| Synflorix Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-18C | 344 subjects |
| Synflorix Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-1 | 344 subjects |
| Synflorix Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-19F | 344 subjects |
| Prevenar Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-1 | 44 subjects |
| Prevenar Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-5 | 85 subjects |
| Prevenar Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-6B | 122 subjects |
| Prevenar Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-19F | 123 subjects |
| Prevenar Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-23F | 122 subjects |
| Prevenar Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-PD | 123 subjects |
| Prevenar Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-4 | 123 subjects |
| Prevenar Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-7F | 22 subjects |
| Prevenar Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-9V | 123 subjects |
| Prevenar Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-14 | 123 subjects |
| Prevenar Group | Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes | Anti-18C | 123 subjects |
Secondary
Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value
Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). Pneumococcal cross-reactive serotypes were 6A and 19A.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-6A | 232 subjects |
| Synflorix Group | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-19A | 203 subjects |
| Prevenar Group | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-6A | 85 subjects |
| Prevenar Group | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-19A | 33 subjects |
Secondary
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes
The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as \>= 8.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes | Opsono-19A (N= 162; 60) | 53 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes | Opsono-6A (N=158; 60) | 134 subjects |
| Prevenar Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes | Opsono-6A (N=158; 60) | 54 subjects |
| Prevenar Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes | Opsono-19A (N= 162; 60) | 7 subjects |
Secondary
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value
The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was \>= 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-6B (N=162; 63) | 152 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-7F (N=164; 59) | 164 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-4 (N=161; 63) | 158 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-9V (N= 165; 63) | 164 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-18C (N= 159; 63) | 142 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-14 (N= 165; 63) | 163 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-19F (N=164; 61) | 159 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-5 (N=165; 62) | 161 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-23F (N= 164; 63) | 160 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-1 (N=162; 62) | 150 subjects |
| Prevenar Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-23F (N= 164; 63) | 62 subjects |
| Prevenar Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-1 (N=162; 62) | 8 subjects |
| Prevenar Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-6B (N=162; 63) | 63 subjects |
| Prevenar Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-9V (N= 165; 63) | 62 subjects |
| Prevenar Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-14 (N= 165; 63) | 62 subjects |
| Prevenar Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-4 (N=161; 63) | 63 subjects |
| Prevenar Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-5 (N=165; 62) | 6 subjects |
| Prevenar Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-7F (N=164; 59) | 40 subjects |
| Prevenar Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-18C (N= 159; 63) | 61 subjects |
| Prevenar Group | Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | Opsono-19F (N=164; 61) | 55 subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With Serious Adverse Events (SAE) | 56 subjects |
| Prevenar Group | Number of Subjects With Serious Adverse Events (SAE) | 9 subjects |
Secondary
Number of Subjects With Seroprotection Status Against PRP
Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Seroprotection Status Against PRP | Above 0.15 | 175 subjects |
| Synflorix Group | Number of Subjects With Seroprotection Status Against PRP | Above 1.0 | 173 subjects |
| Prevenar Group | Number of Subjects With Seroprotection Status Against PRP | Above 0.15 | 60 subjects |
| Prevenar Group | Number of Subjects With Seroprotection Status Against PRP | Above 1.0 | 58 subjects |
Secondary
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature \>= 37.5 degrees Celsius.
Time frame: Within 4 days after each vaccination
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 212 subjects |
| Synflorix Group | Number of Subjects With Solicited General Symptoms | Fever | 113 subjects |
| Synflorix Group | Number of Subjects With Solicited General Symptoms | Irritability | 293 subjects |
| Synflorix Group | Number of Subjects With Solicited General Symptoms | Loss of Appetite | 177 subjects |
| Prevenar Group | Number of Subjects With Solicited General Symptoms | Loss of Appetite | 66 subjects |
| Prevenar Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 65 subjects |
| Prevenar Group | Number of Subjects With Solicited General Symptoms | Irritability | 99 subjects |
| Prevenar Group | Number of Subjects With Solicited General Symptoms | Fever | 33 subjects |