Infections, Rotavirus
Conditions
Keywords
Pneumococcal vaccine., Pneumococcal disease, Safety, Immunogenicity, Primary vaccination
Brief summary
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Taiwanese infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine and rotavirus vaccine in children during the first 6 months of life.
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALSynflorix
Intramuscular injection, 3 doses.
BIOLOGICALInfanrix hexa
Intramuscular injection, 3 doses.
BIOLOGICALRotarix
Oral, 2 doses.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects between, and including 6-8 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. * Written informed consent obtained from the parent(s) or guardian(s) of the subject. * Free of obvious 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.
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. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month after dose 3. * 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. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * 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. * Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae; with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (e.g. Hepatitis B and Bacillus Calmette-Guérin (BCG)). * History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b disease. * Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). * Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Anti-Protein D Antibodies | One month after the third dose | Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL). |
| Concentration of Anti-Pneumococcal Antibodies | One month after the third dose | Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/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 Anti-Protein D Antibody Concentrations Above the Cut-Off Value | Before the first dose (pre) and one month after (post) the third dose | Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL). |
| Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Before the first dose (pre) and one month after (post) the third dose | Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL). 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 third dose | Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL). |
| Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | One month after the third dose | Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer. |
| Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value | One month after the third dose | Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer. |
| Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value | One month after the third dose | Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL). |
| Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value | One month after the third dose | Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL). |
| Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value | One month after the third dose | Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer. |
| Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value | Four months after the administration of the second dose of Rotarix™ vaccine | Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL). |
| Number of Subjects Reporting Solicited Symptoms | During the 4-day (Day 0-3) period after each dose | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include diarrhoea, drowsiness, fever, irritability, loss of appetite, and vomiting |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | During the 31-day (Day 0-30) period after each dose | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product |
| Number of Subjects Reporting Serious Adverse Events (SAE) | Up to one month after the third dose | 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. |
| Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | One month after the third dose | Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL). |
| Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value | One month after the third dose | Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL). |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Synflorix Group Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age. | 230 |
| Total | 230 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Synflorix Group |
|---|---|
| Age, Continuous | 6.4 weeks STANDARD_DEVIATION 0.6 |
| Sex: Female, Male Female | 115 Participants |
| Sex: Female, Male Male | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 224 / 230 |
| serious Total, serious adverse events | 15 / — |
Outcome results
Primary
Concentration of Anti-Pneumococcal Antibodies
Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: One month after the third dose
Population: Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Concentration of Anti-Pneumococcal Antibodies | Anti-1 | 2.92 µg/mL |
| Synflorix Group | Concentration of Anti-Pneumococcal Antibodies | Anti-4 | 3.79 µg/mL |
| Synflorix Group | Concentration of Anti-Pneumococcal Antibodies | Anti-5 | 4.50 µg/mL |
| Synflorix Group | Concentration of Anti-Pneumococcal Antibodies | Anti-6B | 1.69 µg/mL |
| Synflorix Group | Concentration of Anti-Pneumococcal Antibodies | Anti-7F | 4.07 µg/mL |
| Synflorix Group | Concentration of Anti-Pneumococcal Antibodies | Anti-9V | 3.90 µg/mL |
| Synflorix Group | Concentration of Anti-Pneumococcal Antibodies | Anti-14 | 5.69 µg/mL |
| Synflorix Group | Concentration of Anti-Pneumococcal Antibodies | Anti-18C | 7.28 µg/mL |
| Synflorix Group | Concentration of Anti-Pneumococcal Antibodies | Anti-19F | 8.04 µg/mL |
| Synflorix Group | Concentration of Anti-Pneumococcal Antibodies | Anti-23F | 2.81 µg/mL |
Primary
Concentration of Anti-Protein D Antibodies
Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).
Time frame: One month after the third dose
Population: Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix Group | Concentration of Anti-Protein D Antibodies | 2277.6 EL.U/mL |
Secondary
Number of Subjects Reporting 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: Up to one month after the third dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects Reporting Serious Adverse Events (SAE) | 15 subjects |
Secondary
Number of Subjects Reporting Solicited Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include diarrhoea, drowsiness, fever, irritability, loss of appetite, and vomiting
Time frame: During the 4-day (Day 0-3) period after each dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects Reporting Solicited Symptoms | Pain | 146 subjects |
| Synflorix Group | Number of Subjects Reporting Solicited Symptoms | Redness | 144 subjects |
| Synflorix Group | Number of Subjects Reporting Solicited Symptoms | Swelling | 139 subjects |
| Synflorix Group | Number of Subjects Reporting Solicited Symptoms | Diarrhoea | 7 subjects |
| Synflorix Group | Number of Subjects Reporting Solicited Symptoms | Drowsiness | 190 subjects |
| Synflorix Group | Number of Subjects Reporting Solicited Symptoms | Fever | 153 subjects |
| Synflorix Group | Number of Subjects Reporting Solicited Symptoms | Irritability | 203 subjects |
| Synflorix Group | Number of Subjects Reporting Solicited Symptoms | Loss of appetite | 159 subjects |
| Synflorix Group | Number of Subjects Reporting Solicited Symptoms | Vomiting | 55 subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Time frame: During the 31-day (Day 0-30) period after each dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 95 subjects |
Secondary
Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value
Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL).
Time frame: One month after the third dose
Population: Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value | Anti-diphteria toxoid | 58 subjects |
| Synflorix Group | Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value | Anti-tetanus toxoid | 58 subjects |
Secondary
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value
Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL).
Time frame: One month after the third dose
Population: Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | 32 subjects |
Secondary
Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value
Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).
Time frame: One month after the third dose
Population: Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value | Anti-PT (N=58) | 58 subjects |
| Synflorix Group | Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value | Anti-FHA (N=58) | 58 subjects |
| Synflorix Group | Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value | Anti-PRN (N=57) | 57 subjects |
Secondary
Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value
Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer.
Time frame: One month after the third dose
Population: Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value | Anti-poliovirus 1 | 44 subjects |
| Synflorix Group | Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value | Anti-poliovirus 2 | 44 subjects |
| Synflorix Group | Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value | Anti-poliovirus 3 | 44 subjects |
Secondary
Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value
Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL).
Time frame: One month after the third dose
Population: Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value | 58 subjects |
Secondary
Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value
Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).
Time frame: Before the first dose (pre) and one month after (post) the third dose
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value | Pre (N=217) | 38 subjects |
| Synflorix Group | Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value | Post (N=219) | 218 subjects |
Secondary
Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value
Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL).
Time frame: Four months after the administration of the second dose of Rotarix™ vaccine
Population: Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Group | Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value | 44 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 0.05 microgram per milliliter (µg/mL).
Time frame: One month after the third dose
Population: Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-6A (N=219) | 210 subjects |
| Synflorix Group | Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-19A (N=218) | 200 subjects |
Secondary
Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value
Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.
Time frame: One month after the third dose
Population: Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value | Opsono-6A | 87 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value | Opsono-19A | 38 subjects |
Secondary
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value
Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.
Time frame: One month after the third dose
Population: Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | Opsono-1 (N=102) | 98 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | Opsono-4 (N=103) | 103 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | Opsono-5 (N=102) | 101 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | Opsono-6B (N=102) | 89 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | Opsono-7F (N=103) | 103 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | Opsono-9V (N=98) | 98 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | Opsono-14 (N=102) | 101 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | Opsono-18C (N=101) | 99 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | Opsono-19F (N=103) | 101 subjects |
| Synflorix Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | Opsono-23F (N=102) | 98 subjects |
Secondary
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value
Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: Before the first dose (pre) and one month after (post) the third dose
Population: Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-1 Pre (N=217) | 111 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-1 Post (N=219) | 219 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-4 Pre (N=217) | 85 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-4 Post (N=219) | 219 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-5 Pre (N=217) | 149 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-5 Post (N=219) | 219 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-6B Pre (N=217) | 107 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-6B Post (N=219) | 215 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-7F Pre (N=218) | 138 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-7F Post (N=219) | 219 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-9V Pre (N=218) | 123 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-9V Post (N=219) | 219 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-14 Pre (N=218) | 203 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-14 Post (N=219) | 219 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-18C Pre (N=219) | 153 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-18C Post (N=219) | 219 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-19F Pre (N=219) | 172 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-19F Post (N=219) | 219 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-23F Pre (N=219) | 91 subjects |
| Synflorix Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-23F Post (N=219) | 216 subjects |