Hepatitis B, Acellular Pertussis, Tetanus, Poliomyelitis, Diphtheria, Streptococcus Pneumoniae Vaccines
Conditions
Keywords
Fever., Meningococcal disease., Pneumococcal disease., Meningococcal vaccine., Pneumococcal vaccine., Immunogenicity., Booster vaccination., Safety.
Brief summary
The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334).
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
Intramuscular injection, 1 dose.
Intramuscular injection, 1 dose.
Intramuscular injection, 1 dose. In Germany and Poland.
Intramuscular injection, 1 dose. In Spain.
Intramuscular injection, 1 dose. In Germany and Poland.
Intramuscular injection, 1 dose. In Spain.
Intramuscular injection, 1 dose.
Intramuscular injection, 1 dose.
Intramuscular injection, 1 dose.
Sponsors
Study design
Eligibility
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 11-18 months of age at the time of the booster vaccination. * A male or female who previously participated in study 107005 and received three doses of pneumococcal conjugate vaccine. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines. * Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit (one month after the booster dose of study vaccines). * Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, MenC and/or Hib-MenC vaccines other than the study vaccines from study 107005. * History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease. * Acute disease at the time of enrolment. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * Administration of immunoglobulins and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study (starting with the administration of the booster dose of study vaccines up to the follow-up visit one month after).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C) | During the 4-day (Day 0-3) period after the booster vaccination | Fever was measured as rectal temperature. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited General Symptoms | During the 4-day (Day 0-3) period after the booster vaccination | Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite. |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | During the 31-day (Day 0-30) period after the booster vaccination | 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) | During the 31-day (Day 0-30) period after the booster vaccination | 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 Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Before (pre) and one month after (post) the booster administration | Anti-pneumococcal antibody concentration 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 Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Before (pre) and one month after (post) the booster administration | 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, 23F. |
| Number of Subjects Reporting Solicited Local Symptoms | During the 4-day (Day 0-3) period after the booster vaccination | Solicited local symptoms assessed include pain, redness and swelling. |
| Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Before (pre) and one month after (post) the booster administration | Anti-pneumococcal antibody cut-off value assessed was ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A. |
| Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Before (pre) and one month after (post) the booster administration | Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL). |
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value | Before (pre) and one month after (post) the booster administration | Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8. |
| Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value | Before (pre) and one month after (post) the booster administration | Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL. |
| Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value | Before (pre) and one month after (post) the booster administration | Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL. |
| Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Before (pre) and one month after (post) the booster administration | Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A. |
Countries
Germany, Poland, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age. | 359 |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age. | 363 |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age. | 358 |
| Prevenar™ + Menitorix™ Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age. | 357 |
| Total | 1,437 |
Baseline characteristics
| Characteristic | GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Prevenar™ + Menitorix™ | Total |
|---|---|---|---|---|---|
| Age, Continuous | 14.3 Months STANDARD_DEVIATION 1.81 | 14.3 Months STANDARD_DEVIATION 1.74 | 14.3 Months STANDARD_DEVIATION 1.78 | 14.3 Months STANDARD_DEVIATION 1.78 | 14.3 Months STANDARD_DEVIATION 1.78 |
| Sex: Female, Male Female | 182 Participants | 176 Participants | 195 Participants | 171 Participants | 724 Participants |
| Sex: Female, Male Male | 177 Participants | 187 Participants | 163 Participants | 186 Participants | 713 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 297 / 359 | 303 / 363 | 302 / 358 | 287 / 357 |
| serious Total, serious adverse events | 15 / — | 9 / — | 13 / — | 13 / — |
Outcome results
Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)
Fever was measured as rectal temperature.
Time frame: During the 4-day (Day 0-3) period after the booster vaccination
Population: Analysis was performed on the Total vaccinated cohort from Pn-HibC and Pr-HibC Groups on subjects for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C) | 11 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C) | 8 subjects |
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: From the beginning of the study up to the end of the extended 6-month safety follow-up period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects Reporting Serious Adverse Events (SAE) | 15 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects Reporting Serious Adverse Events (SAE) | 9 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects Reporting Serious Adverse Events (SAE) | 13 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects Reporting Serious Adverse Events (SAE) | 13 subjects |
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: During the 31-day (Day 0-30) period after the booster vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects Reporting Serious Adverse Events (SAE) | 3 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects Reporting Serious Adverse Events (SAE) | 5 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects Reporting Serious Adverse Events (SAE) | 3 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects Reporting Serious Adverse Events (SAE) | 2 subjects |
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
Time frame: During the 4-day (Day 0-3) period after the booster vaccination
Population: Subjects from the Total Vaccinated cohort for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects Reporting Solicited General Symptoms | Drowsiness | 124 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects Reporting Solicited General Symptoms | Fever (≥ 38.0 °C) | 109 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects Reporting Solicited General Symptoms | Irritability | 170 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects Reporting Solicited General Symptoms | Loss of appetite | 101 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects Reporting Solicited General Symptoms | Fever (≥ 38.0 °C) | 122 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects Reporting Solicited General Symptoms | Irritability | 190 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects Reporting Solicited General Symptoms | Loss of appetite | 99 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects Reporting Solicited General Symptoms | Drowsiness | 142 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects Reporting Solicited General Symptoms | Irritability | 191 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects Reporting Solicited General Symptoms | Fever (≥ 38.0 °C) | 105 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects Reporting Solicited General Symptoms | Loss of appetite | 112 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects Reporting Solicited General Symptoms | Drowsiness | 139 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects Reporting Solicited General Symptoms | Loss of appetite | 93 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects Reporting Solicited General Symptoms | Fever (≥ 38.0 °C) | 108 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects Reporting Solicited General Symptoms | Drowsiness | 105 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects Reporting Solicited General Symptoms | Irritability | 157 subjects |
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Time frame: During the 4-day (Day 0-3) period after the booster vaccination
Population: Subjects from the Total Vaccinated cohort for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects Reporting Solicited Local Symptoms | Pain | 196 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 162 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects Reporting Solicited Local Symptoms | Redness | 194 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects Reporting Solicited Local Symptoms | Pain | 195 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 148 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects Reporting Solicited Local Symptoms | Redness | 183 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects Reporting Solicited Local Symptoms | Redness | 186 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects Reporting Solicited Local Symptoms | Pain | 193 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 150 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects Reporting Solicited Local Symptoms | Pain | 165 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 134 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects Reporting Solicited Local Symptoms | Redness | 173 subjects |
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 the booster vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 59 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 74 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 59 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 76 subjects |
Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value
Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL.
Time frame: Before (pre) and one month after (post) the booster administration
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value | Pre (n=126,124,125,135) | 95 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value | Post (n=156,149,159,149) | 156 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value | Post (n=156,149,159,149) | 149 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value | Pre (n=126,124,125,135) | 82 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value | Pre (n=126,124,125,135) | 105 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value | Post (n=156,149,159,149) | 159 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value | Pre (n=126,124,125,135) | 102 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value | Post (n=156,149,159,149) | 149 subjects |
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 ≥ 0.15 µg/mL.
Time frame: Before (pre) and one month after (post) the booster administration
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value | Pre (n=147,144,150,148) | 122 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value | Post (n=157,153,160,152) | 157 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value | Pre (n=147,144,150,148) | 128 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value | Post (n=157,153,160,152) | 153 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value | Post (n=157,153,160,152) | 160 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value | Pre (n=147,144,150,148) | 145 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value | Pre (n=147,144,150,148) | 143 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value | Post (n=157,153,160,152) | 152 subjects |
Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value
Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Time frame: Before (pre) and one month after (post) the booster administration
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Pre (n=147,153,147,146) | 144 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Post (n=158,152,160,148) | 158 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Post (n=158,152,160,148) | 151 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Pre (n=147,153,147,146) | 147 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Pre (n=147,153,147,146) | 138 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Post (n=158,152,160,148) | 160 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Pre (n=147,153,147,146) | 59 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Post (n=158,152,160,148) | 66 subjects |
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). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Time frame: Before (pre) and one month after (post) the booster administration
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6A pre (n=145,144,144,149) | 126 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6A post (n=156,152,159,152) | 152 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19A pre (n=145,153,145,151) | 130 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19A post (n=157,153,160,152) | 154 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6A post (n=156,152,159,152) | 145 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19A pre (n=145,153,145,151) | 138 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19A post (n=157,153,160,152) | 151 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6A pre (n=145,144,144,149) | 120 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19A pre (n=145,153,145,151) | 121 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6A post (n=156,152,159,152) | 149 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19A post (n=157,153,160,152) | 155 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6A pre (n=145,144,144,149) | 119 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19A post (n=157,153,160,152) | 149 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6A post (n=156,152,159,152) | 148 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6A pre (n=145,144,144,149) | 110 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19A pre (n=145,153,145,151) | 87 subjects |
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value
Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8.
Time frame: Before (pre) and one month after (post) the booster administration
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value | Pre (n=68,65,66,78) | 57 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value | Post (n=89,84,79,76) | 89 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value | Post (n=89,84,79,76) | 84 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value | Pre (n=68,65,66,78) | 62 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value | Pre (n=68,65,66,78) | 62 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value | Post (n=89,84,79,76) | 79 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value | Pre (n=68,65,66,78) | 68 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value | Post (n=89,84,79,76) | 76 subjects |
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value
Anti-pneumococcal antibody cut-off value assessed was ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Time frame: Before (pre) and one month after (post) the booster administration
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-6A pre (n=108,110,106,110) | 68 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-6A post (n=127,128,128,122) | 116 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-19A pre (n=133,138,136,134) | 4 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-19A post (n=124,132,130,123) | 77 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-6A post (n=127,128,128,122) | 119 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-19A pre (n=133,138,136,134) | 11 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-19A post (n=124,132,130,123) | 75 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-6A pre (n=108,110,106,110) | 66 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-19A pre (n=133,138,136,134) | 4 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-6A post (n=127,128,128,122) | 117 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-19A post (n=124,132,130,123) | 50 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-6A pre (n=108,110,106,110) | 73 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-19A post (n=124,132,130,123) | 29 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-6A post (n=127,128,128,122) | 119 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-6A pre (n=108,110,106,110) | 62 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Opsono-19A pre (n=133,138,136,134) | 2 subjects |
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 ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F.
Time frame: Before (pre) and one month after (post) the booster administration
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-9V pre (n=133,133,130,130) | 131 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-9V post (n=143,139,143,137) | 143 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-4 post (n=137,134,140,135) | 137 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-18C pre (n=126,118,123,123) | 45 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-14 pre (n=121,125,114,125) | 115 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-1 pre (n=144,145,141,143) | 46 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-14 post (n=137,138,138,134) | 137 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-1 post (n=140,139,140,137) | 132 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-23F pre (n=132,136,128,137) | 121 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-5 pre (n=116,114,117,124) | 77 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-5 post (n=124,130,136,127) | 121 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19F post (n=137,137,139,133) | 133 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6B pre (n=133,132,133,137) | 75 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-23F post (n=145,143,146,143) | 145 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6B post (n=142,135,142,140) | 134 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-4 pre (n=104,121,112,109) | 61 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19F pre (n=127,135,134,134) | 102 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-7F pre (n=111,122,115,104) | 109 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-7F post (n=140,137,139,112) | 140 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-18C post (n=121,129,121,114) | 121 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-5 post (n=124,130,136,127) | 127 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-9V pre (n=133,133,130,130) | 130 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-23F pre (n=132,136,128,137) | 120 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-18C pre (n=126,118,123,123) | 54 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-1 pre (n=144,145,141,143) | 39 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-9V post (n=143,139,143,137) | 139 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-23F post (n=145,143,146,143) | 143 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-7F post (n=140,137,139,112) | 137 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-5 pre (n=116,114,117,124) | 71 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-14 pre (n=121,125,114,125) | 116 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6B pre (n=133,132,133,137) | 60 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-14 post (n=137,138,138,134) | 138 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-7F pre (n=111,122,115,104) | 117 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-4 post (n=137,134,140,135) | 134 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19F pre (n=127,135,134,134) | 110 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-4 pre (n=104,121,112,109) | 67 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6B post (n=142,135,142,140) | 127 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-1 post (n=140,139,140,137) | 133 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19F post (n=137,137,139,133) | 132 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-18C post (n=121,129,121,114) | 127 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-14 pre (n=121,125,114,125) | 107 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-1 pre (n=144,145,141,143) | 41 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-1 post (n=140,139,140,137) | 127 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-4 pre (n=104,121,112,109) | 61 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-4 post (n=137,134,140,135) | 140 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-5 pre (n=116,114,117,124) | 72 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-5 post (n=124,130,136,127) | 131 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6B pre (n=133,132,133,137) | 75 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6B post (n=142,135,142,140) | 135 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-7F pre (n=111,122,115,104) | 109 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-7F post (n=140,137,139,112) | 139 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-9V pre (n=133,133,130,130) | 122 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-9V post (n=143,139,143,137) | 143 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-14 post (n=137,138,138,134) | 138 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-18C pre (n=126,118,123,123) | 34 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-18C post (n=121,129,121,114) | 121 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19F pre (n=127,135,134,134) | 95 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19F post (n=137,137,139,133) | 139 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-23F pre (n=132,136,128,137) | 105 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-23F post (n=145,143,146,143) | 146 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-7F post (n=140,137,139,112) | 53 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-7F pre (n=111,122,115,104) | 42 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-23F pre (n=132,136,128,137) | 124 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-18C post (n=121,129,121,114) | 110 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6B post (n=142,135,142,140) | 138 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6B pre (n=133,132,133,137) | 67 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-1 post (n=140,139,140,137) | 12 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19F pre (n=127,135,134,134) | 29 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-5 post (n=124,130,136,127) | 4 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-5 pre (n=116,114,117,124) | 3 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-1 pre (n=144,145,141,143) | 8 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19F post (n=137,137,139,133) | 131 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-4 post (n=137,134,140,135) | 135 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-14 pre (n=121,125,114,125) | 124 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-4 pre (n=104,121,112,109) | 73 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-14 post (n=137,138,138,134) | 134 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-9V post (n=143,139,143,137) | 137 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-9V pre (n=133,133,130,130) | 126 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-23F post (n=145,143,146,143) | 143 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-18C pre (n=126,118,123,123) | 35 subjects |
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-pneumococcal antibody concentration 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 (pre) and one month after (post) the booster administration
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-18C post (n=157,152,160,152) | 157 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-9V post (n=158,153,160,153) | 158 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-4 post (n=158,153,160,152) | 158 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-18C pre (n=151,153,145,151) | 149 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-14 pre (n=153,158,152,153) | 151 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-1 pre (n=150,152,149, 151) | 146 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-14 post (n=158,153,160,153) | 158 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-1 post (n=158,152,160,151) | 158 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-23F pre (n=152,156,150,153) | 149 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-5 pre (n=149,146,146,148) | 149 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-5 post (n=157,153,160,150) | 157 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19F post (n=158,151,160,152) | 158 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6B pre (n=151,155,150,151) | 149 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-23F post (n=158,153,160,153) | 158 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6B post (n=158,153,160,153) | 157 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-4 pre (n=153,156,150,153) | 152 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19F pre (n=143,146,139,150) | 143 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-7F pre (n=149,153,148,151) | 149 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-7F post (n=158,152,160,151) | 158 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-9V pre (n=149,155,149,152) | 149 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-18C post (n=157,152,160,152) | 152 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-9V pre (n=149,155,149,152) | 154 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-23F pre (n=152,156,150,153) | 153 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-18C pre (n=151,153,145,151) | 151 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-5 post (n=157,153,160,150) | 153 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-9V post (n=158,153,160,153) | 152 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-1 pre (n=150,152,149, 151) | 146 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-23F post (n=158,153,160,153) | 152 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-7F post (n=158,152,160,151) | 152 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-14 pre (n=153,158,152,153) | 157 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6B pre (n=151,155,150,151) | 153 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-14 post (n=158,153,160,153) | 153 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-7F pre (n=149,153,148,151) | 153 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-4 post (n=158,153,160,152) | 153 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19F pre (n=143,146,139,150) | 146 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-4 pre (n=153,156,150,153) | 156 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6B post (n=158,153,160,153) | 151 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-5 pre (n=149,146,146,148) | 146 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-1 post (n=158,152,160,151) | 152 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19F post (n=158,151,160,152) | 151 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-14 pre (n=153,158,152,153) | 152 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-1 pre (n=150,152,149, 151) | 140 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-1 post (n=158,152,160,151) | 160 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-4 pre (n=153,156,150,153) | 147 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-4 post (n=158,153,160,152) | 160 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-5 pre (n=149,146,146,148) | 144 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-5 post (n=157,153,160,150) | 160 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6B pre (n=151,155,150,151) | 144 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6B post (n=158,153,160,153) | 158 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-7F pre (n=149,153,148,151) | 147 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-7F post (n=158,152,160,151) | 160 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-9V pre (n=149,155,149,152) | 149 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-9V post (n=158,153,160,153) | 160 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-14 post (n=158,153,160,153) | 160 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-18C pre (n=151,153,145,151) | 145 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-18C post (n=157,152,160,152) | 160 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19F pre (n=143,146,139,150) | 139 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19F post (n=158,151,160,152) | 160 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-23F pre (n=152,156,150,153) | 144 subjects |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-23F post (n=158,153,160,153) | 158 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-7F post (n=158,152,160,151) | 25 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-7F pre (n=149,153,148,151) | 18 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-23F pre (n=152,156,150,153) | 141 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-18C post (n=157,152,160,152) | 152 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6B post (n=158,153,160,153) | 153 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6B pre (n=151,155,150,151) | 137 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-1 post (n=158,152,160,151) | 28 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19F pre (n=143,146,139,150) | 143 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-5 post (n=157,153,160,150) | 64 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-5 pre (n=149,146,146,148) | 37 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-1 pre (n=150,152,149, 151) | 21 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19F post (n=158,151,160,152) | 152 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-4 post (n=158,153,160,152) | 152 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-14 pre (n=153,158,152,153) | 151 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-4 pre (n=153,156,150,153) | 150 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-14 post (n=158,153,160,153) | 153 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-9V post (n=158,153,160,153) | 153 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-9V pre (n=149,155,149,152) | 152 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-23F post (n=158,153,160,153) | 153 subjects |
| Prevenar™ + Menitorix™ | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-18C pre (n=151,153,145,151) | 151 subjects |