Infections, Streptococcal
Conditions
Keywords
immunogenicity, toddlers, Pneumococcal vaccine, Haemophilus influenzae, safety, Streptococcus pneumoniae, Streptococcus Pneumoniae Vaccines
Brief summary
This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature \>40.0°C).
Interventions
Three doses will be administered intramuscularly, at Month 0, 2 and 6.
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Sponsors
Study design
Eligibility
Inclusion criteria
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol * Male or female between, and including, 12 and 23 months of age at the time of the first vaccination. * Written informed consent obtained from the parents/LAR(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s). * Previous vaccination against S. pneumoniae since birth. * History of any hypersensitivity reaction following any previous vaccination. * Eczema and any history of allergy * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection. * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or any chronic illness. * History of any neurologic disorders or seizures. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature \>= 37.5°C on oral or axillary setting, or \>= 38.0°C on rectal setting. * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period. * Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Fever > 40.0°C (Rectal Temperature) | Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination | The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose) | Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) follow-up period after each primary 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. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) | Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose) | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity. |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) | Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8. |
| Antibody Concentrations to Protein D (Anti-PD) | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) | Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL). |
| Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) | Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140. |
| Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) | Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL). |
Countries
Czechia
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| GSK 2189242A-LD Group Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). | 51 |
| GSK 2189242A-HD Group Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). | 52 |
| Synflorix/GSK 2189242A-LD Group Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). | 52 |
| Synflorix/GSK 2189242A-HD Group Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). | 51 |
| Synflorix Group Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). | 51 |
| Total | 257 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | GSK 2189242A-LD Group | GSK 2189242A-HD Group | Synflorix/GSK 2189242A-LD Group | Synflorix/GSK 2189242A-HD Group | Synflorix Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 17 Months STANDARD_DEVIATION 3.6 | 16.7 Months STANDARD_DEVIATION 3.81 | 17.1 Months STANDARD_DEVIATION 4.03 | 16.8 Months STANDARD_DEVIATION 3.96 | 16.3 Months STANDARD_DEVIATION 4.18 | 16.78 Months STANDARD_DEVIATION 3.9 |
| Race/Ethnicity, Customized White-Arabic/North African heritage | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 51 Participants | 52 Participants | 51 Participants | 51 Participants | 49 Participants | 254 Participants |
| Sex: Female, Male Female | 25 Participants | 22 Participants | 23 Participants | 29 Participants | 28 Participants | 127 Participants |
| Sex: Female, Male Male | 26 Participants | 30 Participants | 29 Participants | 22 Participants | 23 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 52 | 0 / 52 | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 47 / 51 | 49 / 52 | 49 / 52 | 49 / 51 | 49 / 51 |
| serious Total, serious adverse events | 5 / 51 | 3 / 52 | 5 / 52 | 0 / 51 | 4 / 51 |
Outcome results
Number of Subjects With Fever > 40.0°C (Rectal Temperature)
The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.
Time frame: Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Group | Number of Subjects With Fever > 40.0°C (Rectal Temperature) | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects With Fever > 40.0°C (Rectal Temperature) | 1 Participants |
Number of Subjects With Fever > 40.0°C (Rectal Temperature)
The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.
Time frame: Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Group | Number of Subjects With Fever > 40.0°C (Rectal Temperature) | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects With Fever > 40.0°C (Rectal Temperature) | 1 Participants |
Antibody Concentrations to Protein D (Anti-PD)
Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL).
Time frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Post-Dose 2 | 90.9 LU/mL |
| Synflorix Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Post-booster | 97.9 LU/mL |
| Synflorix Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Pre-booster | 89.1 LU/mL |
| Synflorix/GSK 2189242A Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Pre-booster | 118.2 LU/mL |
| Synflorix/GSK 2189242A Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Post-Dose 2 | 100.4 LU/mL |
| Synflorix/GSK 2189242A Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Post-booster | 130.6 LU/mL |
| Synflorix/GSK 2189242A-LD Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Pre-booster | 734.6 LU/mL |
| Synflorix/GSK 2189242A-LD Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Post-Dose 2 | 1105.4 LU/mL |
| Synflorix/GSK 2189242A-LD Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Post-booster | 1882.6 LU/mL |
| Synflorix/GSK 2189242A-HD Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Post-Dose 2 | 600.2 LU/mL |
| Synflorix/GSK 2189242A-HD Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Post-booster | 1474.6 LU/mL |
| Synflorix/GSK 2189242A-HD Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Pre-booster | 463 LU/mL |
| Synflorix Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Pre-booster | 691.8 LU/mL |
| Synflorix Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Post-Dose 2 | 860 LU/mL |
| Synflorix Group | Antibody Concentrations to Protein D (Anti-PD) | Anti-PD, Post-booster | 1963.8 LU/mL |
Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations
Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL.
Time frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Post-dose 2 | 135703.5 LU/mL |
| Synflorix Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Pre-booster | 100811.4 LU/mL |
| Synflorix Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Post-booster | 224726.2 LU/mL |
| Synflorix Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Post-dose 2 | 30402.84 LU/mL |
| Synflorix Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Pre-booster | 24350.58 LU/mL |
| Synflorix Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Post-booster | 65584.24 LU/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Pre-booster | 23918.77 LU/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Post-booster | 77312.07 LU/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Post-dose 2 | 148447.5 LU/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Post-booster | 305912.3 LU/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Post-dose 2 | 35043.91 LU/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Pre-booster | 96552.52 LU/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Post-dose 2 | 23438.06 LU/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Pre-booster | 14375.59 LU/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Post-dose 2 | 32436.07 LU/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Post-booster | 44123.43 LU/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Pre-booster | 19573.55 LU/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Post-booster | 32609.19 LU/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Post-dose 2 | 22141.18 LU/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Pre-booster | 29592.91 LU/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Post-booster | 85805.02 LU/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Post-booster | 36098.18 LU/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Pre-booster | 12721.01 LU/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Post-dose 2 | 57149.83 LU/mL |
| Synflorix Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Pre-booster | 4814.97 LU/mL |
| Synflorix Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Post-booster | 4553.43 LU/mL |
| Synflorix Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Pre-booster | 4654.16 LU/mL |
| Synflorix Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Post-booster | 5072.43 LU/mL |
| Synflorix Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-PhtD, Post-dose 2 | 3795.68 LU/mL |
| Synflorix Group | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Anti-dPly, Post-dose 2 | 3759.82 LU/mL |
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).
Time frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Post-booster | 0.06 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Pre-booster | 0.06 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Post-Dose 2 | 0.05 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Pre-booster | 0.11 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Post-Dose 2 | 0.06 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Post-booster | 0.05 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Pre-booster | 0.05 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Post-Dose 2 | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Post-booster | 0.13 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Pre-booster | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Pre-booster | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Post-booster | 0.05 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Pre-booster | 0.05 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Post-Dose 2 | 0.05 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Post-booster | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Post-Dose 2 | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Post-booster | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Pre-booster | 0.05 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Post-Dose 2 | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Post-Dose 2 | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Post-Dose 2 | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Post-booster | 0.07 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Pre-booster | 0.07 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Post-Dose 2 | 0.07 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Pre-booster | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Post-booster | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Post-booster | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Pre-booster | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Post-Dose 2 | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Post-booster | 0.04 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Post-booster | 0.07 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Post-booster | 0.03 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Pre-booster | 0.03 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Post-Dose 2 | 0.03 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Post-Dose 2 | 0.1 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Pre-booster | 0.07 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Post-booster | 0.04 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Post-Dose 2 | 0.04 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Pre-booster | 0.03 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Post-booster | 0.04 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Post-Dose 2 | 0.03 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Pre-booster | 0.03 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Post-booster | 0.03 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Post-Dose 2 | 0.09 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Pre-booster | 0.11 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Post-booster | 0.16 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Post-Dose 2 | 0.04 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Pre-booster | 0.04 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Post-booster | 0.05 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Post-Dose 2 | 0.06 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Pre-booster | 0.05 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Post-booster | 0.07 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Post-Dose 2 | 0.04 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Pre-booster | 0.04 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Post-booster | 0.05 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Post-Dose 2 | 0.03 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Pre-booster | 0.04 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Post-booster | 0.04 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Post-Dose 2 | 0.05 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Pre-booster | 0.05 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Post-booster | 0.05 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Post-Dose 2 | 0.05 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Pre-booster | 0.05 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Post-booster | 0.05 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Post-Dose 2 | 0.03 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Pre-booster | 0.03 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Post-booster | 0.04 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Post-Dose 2 | 0.06 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Pre-booster | 0.06 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Post-booster | 0.07 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Post-Dose 2 | 0.03 µg/mL |
| Synflorix/GSK 2189242A Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Pre-booster | 0.04 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Post-Dose 2 | 0.32 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Pre-booster | 2.3 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Post-Dose 2 | 1.19 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Pre-booster | 2.6 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Post-booster | 5.26 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Post-booster | 7.74 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Post-Dose 2 | 5.03 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Pre-booster | 0.24 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Post-Dose 2 | 13.92 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Post-booster | 1.08 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Pre-booster | 4.94 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Pre-booster | 2.86 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Post-Dose 2 | 2.42 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Post-booster | 16.12 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Pre-booster | 1.44 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Post-Dose 2 | 8.6 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Post-booster | 0.53 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Pre-booster | 4.15 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Post-booster | 10.46 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Post-booster | 3.57 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Post-Dose 2 | 1.08 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Pre-booster | 1.08 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Pre-booster | 0.85 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Pre-booster | 0.71 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Post-Dose 2 | 2.81 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Post-booster | 2.76 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Post-booster | 3.13 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Post-Dose 2 | 2.5 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Post-booster | 1.92 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Pre-booster | 0.87 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Post-Dose 2 | 5.18 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Post-booster | 5.9 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Post-Dose 2 | 0.55 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Post-booster | 2.69 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Pre-booster | 0.39 µg/mL |
| Synflorix/GSK 2189242A-LD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Post-Dose 2 | 6.42 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Post-Dose 2 | 0.48 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Post-Dose 2 | 0.27 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Post-booster | 3.21 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Pre-booster | 2.36 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Post-Dose 2 | 2.08 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Pre-booster | 2.36 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Post-booster | 1.14 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Post-Dose 2 | 0.97 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Post-booster | 5.61 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Pre-booster | 1.26 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Post-booster | 5.25 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Post-booster | 6.62 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Post-Dose 2 | 2.49 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Post-booster | 3.45 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Pre-booster | 0.24 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Post-booster | 2.04 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Post-Dose 2 | 16.92 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Post-Dose 2 | 0.91 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Pre-booster | 2.3 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Pre-booster | 0.68 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Post-booster | 2.47 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Pre-booster | 5.51 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Pre-booster | 4.72 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Pre-booster | 0.75 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Pre-booster | 0.62 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Post-Dose 2 | 4.73 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Post-booster | 21.98 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Post-booster | 2.98 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Pre-booster | 0.42 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Post-Dose 2 | 2.41 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Post-booster | 14.38 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Post-Dose 2 | 10.08 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Post-Dose 2 | 6.6 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Post-Dose 2 | 3.78 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Post-booster | 0.56 µg/mL |
| Synflorix/GSK 2189242A-HD Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Pre-booster | 1.05 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Pre-booster | 4.79 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Pre-booster | 4.33 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Post-booster | 11.32 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Post-booster | 2.18 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Post-Dose 2 | 0.73 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Pre-booster | 0.51 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-23F, Post-booster | 1.47 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Pre-booster | 0.95 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Pre-booster | 1.18 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Post-Dose 2 | 0.31 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Pre-booster | 0.27 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6A, Post-booster | 0.58 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-9V, Post-Dose 2 | 1.55 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Post-Dose 2 | 0.93 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Pre-booster | 0.62 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Post-booster | 3.84 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19A, Post-booster | 2.06 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Post-booster | 4.65 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Post-booster | 1.08 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Post-Dose 2 | 2.13 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Pre-booster | 0.46 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Pre-booster | 0.73 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-1, Post-booster | 2.4 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Pre-booster | 2.14 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Post-Dose 2 | 5.67 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-6B, Post-Dose 2 | 0.55 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Pre-booster | 2.11 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-4, Post-booster | 5.18 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Post-booster | 5.98 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Pre-booster | 2.71 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-7F, Post-Dose 2 | 3.72 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Post-Dose 2 | 12.56 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-18C, Post-booster | 14.62 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-14, Post-Dose 2 | 4.63 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-19F, Post-Dose 2 | 8.87 µg/mL |
| Synflorix Group | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Anti-5, Post-Dose 2 | 2.36 µg/mL |
Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity
Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140.
Time frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Pre-booster | 2441.1 Titers |
| Synflorix Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Post-Dose 2 | 3080 Titers |
| Synflorix Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Post-booster | 4332.4 Titers |
| Synflorix/GSK 2189242A Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Pre-booster | 2193.7 Titers |
| Synflorix/GSK 2189242A Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Post-Dose 2 | 2988.7 Titers |
| Synflorix/GSK 2189242A Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Post-booster | 5931.9 Titers |
| Synflorix/GSK 2189242A-LD Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Pre-booster | 1141.5 Titers |
| Synflorix/GSK 2189242A-LD Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Post-Dose 2 | 1278.9 Titers |
| Synflorix/GSK 2189242A-LD Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Post-booster | 1346.2 Titers |
| Synflorix/GSK 2189242A-HD Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Post-Dose 2 | 1814 Titers |
| Synflorix/GSK 2189242A-HD Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Post-booster | 2388.3 Titers |
| Synflorix/GSK 2189242A-HD Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Pre-booster | 1344.2 Titers |
| Synflorix Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Pre-booster | 995.9 Titers |
| Synflorix Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Post-Dose 2 | 913.2 Titers |
| Synflorix Group | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Anti-Hem-dPly, Post-booster | 818.6 Titers |
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 15 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 17 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 21 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Booster | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Booster | 18 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Booster | 19 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 8 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 18 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Booster | 11 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 11 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Booster | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Booster | 2 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 25 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 22 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Booster | 20 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 15 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Booster | 8 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Booster | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Booster | 2 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Booster | 22 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 20 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Booster | 3 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 9 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 5 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 1 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 31 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Booster | 18 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Booster | 3 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 1 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 32 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 5 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 19 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 2 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 24 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 2 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 23 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 4 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 18 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 5 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Booster | 32 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Booster | 3 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Booster | 28 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Booster | 5 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 2 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 1 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 17 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Booster | 1 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 11 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 4 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 1 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 28 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Booster | 15 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Booster | 26 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 2 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Booster | 4 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Booster | 2 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 23 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 2 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 27 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Booster | 22 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 22 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 27 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 19 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Booster | 21 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Booster | 25 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 3 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Booster | 3 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 2 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 26 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 16 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 3 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 25 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling Booster | 13 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Booster | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 2 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 24 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 4 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Booster | 3 Participants |
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 8 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Booster | 4 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Booster | 9 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 1 | 4 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Booster | 5 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Booster | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Booster | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 1 | 7 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 16 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 6 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Booster | 15 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 4 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 1 | 6 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 2 | 9 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Booster | 7 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 2 | 3 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 1 | 3 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Booster | 2 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Booster | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 15 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 12 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Booster | 13 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Booster | 6 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 2 | 12 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Booster | 8 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 2 | 2 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 2 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 6 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 1 | 21 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 11 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 2 | 12 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 2 | 18 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 1 | 16 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 5 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 2 | 11 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Booster | 4 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 10 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 1 | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Booster | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 1 | 9 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Booster | 10 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 7 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 13 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Booster | 11 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Booster | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Booster | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 1 | 5 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Booster | 17 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 1 | 8 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Booster | 9 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 1 | 1 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 6 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Booster | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 1 | 2 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Booster | 3 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Booster | 13 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 16 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Booster | 10 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 2 | 6 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Booster | 1 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 24 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 0 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 13 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 1 | 31 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 1 | 0 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 1 | 17 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 14 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 1 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 1 | 9 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 1 | 14 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 1 | 1 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 1 | 7 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 17 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 11 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 2 | 22 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 2 | 17 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 12 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 9 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 2 | 8 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 2 | 5 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Booster | 18 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Booster | 0 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Booster | 11 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Booster | 26 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Booster | 0 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Booster | 15 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Booster | 13 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Booster | 7 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Booster | 10 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Booster | 0 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Booster | 7 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 10 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 10 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Booster | 5 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 2 | 7 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 15 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Booster | 12 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 1 | 8 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Booster | 0 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 1 | 0 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 0 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Booster | 10 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 1 | 12 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Booster | 2 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Booster | 17 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 1 | 3 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Booster | 0 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Booster | 1 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 0 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Booster | 13 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 12 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Booster | 15 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 1 | 16 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 1 | 0 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Booster | 1 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 1 | 27 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 20 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Booster | 7 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 9 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 2 | 18 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 2 | 0 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 5 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 2 | 24 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 2 | 9 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Booster | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 2 | 7 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 2 | 21 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Booster | 3 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 14 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Booster | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 23 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 7 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Booster | 13 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 2 | 7 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 2 | 27 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 1 | 9 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Booster | 7 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability Dose 1 | 14 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Booster | 17 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 26 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 13 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Booster | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Booster | 8 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 1 | 12 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 16 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Booster | 11 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability Dose 2 | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 1 | 7 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Booster | 6 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Booster | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Booster | 19 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability Dose 1 | 23 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 18 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 0 Participants |
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 5 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects With Serious Adverse Events (SAEs) | 5 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
Number of Subjects With Unsolicited Adverse Events (AEs)
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. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Time frame: During the 31-day (Days 0-30) follow-up period after the booster dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 14 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 12 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 13 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 4 Participants |
| Synflorix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 9 Participants |
Number of Subjects With Unsolicited Adverse Events (AEs)
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. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Time frame: During the 31-day (Days 0-30) follow-up period after each primary dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 25 Participants |
| Synflorix/GSK 2189242A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 24 Participants |
| Synflorix/GSK 2189242A-LD Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 31 Participants |
| Synflorix/GSK 2189242A-HD Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 24 Participants |
| Synflorix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 22 Participants |
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8.
Time frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Pre-booster | 4.5 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Post-Dose 2 | 4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Post-booster | 11.8 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Pre-booster | 23.2 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Pre-booster | 12.6 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Post-booster | 4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Post-Dose 2 | 7 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Post-booster | 6.7 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Post-Dose 2 | 17.9 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Pre-booster | 21 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Post-Dose 2 | 15 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Pre-booster | 18.4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Pre-booster | 6 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Post-Dose 2 | 5.6 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Post-booster | 15.5 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Pre-booster | 56.7 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Post-Dose 2 | 5.8 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Post-booster | 5.2 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Post-booster | 4.9 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Pre-booster | 4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Post-booster | 26.1 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Post-booster | 173.5 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Post-booster | 32.3 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Pre-booster | 5 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Post-Dose 2 | 4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Post-Dose 2 | 734.6 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Post-Dose 2 | 26.5 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Post-Dose 2 | 9.3 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Post-booster | 6 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Post-Dose 2 | 21.1 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Pre-booster | 670.4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Post-booster | 68.6 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Post-Dose 2 | 4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Pre-booster | 5.4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Pre-booster | 172.4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Post-booster | 936.8 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Post-Dose 2 | 7.3 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Post-Dose 2 | 4.6 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Post-booster | 46.7 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Post-Dose 2 | 50.1 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Pre-booster | 27.9 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Pre-booster | 172 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Post-Dose 2 | 11.9 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Post-booster | 137.6 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Post-Dose 2 | 8.9 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Post-booster | 6.3 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Post-booster | 17.3 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Pre-booster | 16.2 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Pre-booster | 9.4 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Post-booster | 17.8 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Post-Dose 2 | 5.7 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Post-booster | 106.7 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Post-Dose 2 | 4.7 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Pre-booster | 4.3 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Pre-booster | 136.3 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Pre-booster | 4 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Post-Dose 2 | 5.4 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Post-Dose 2 | 107.8 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Post-booster | 5.1 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Pre-booster | 4.5 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Post-booster | 785.5 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Post-Dose 2 | 23.4 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Post-booster | 4.4 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Pre-booster | 61.6 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Pre-booster | 8 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Post-booster | 30.8 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Post-booster | 8.1 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Post-booster | 8 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Post-Dose 2 | 807.4 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Pre-booster | 5 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Pre-booster | 462.3 Titers |
| Synflorix/GSK 2189242A Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Post-Dose 2 | 7.4 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Pre-booster | 2450.1 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Post-Dose 2 | 71.8 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Pre-booster | 23 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Post-booster | 169.5 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Post-Dose 2 | 1260.2 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Pre-booster | 247.9 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Post-booster | 1206.2 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Post-Dose 2 | 43.8 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Pre-booster | 12.8 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Post-booster | 99.3 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Post-Dose 2 | 361.9 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Pre-booster | 213.8 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Post-booster | 804.6 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Post-Dose 2 | 5703.7 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Post-booster | 4109.3 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Post-Dose 2 | 4455 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Pre-booster | 2126.1 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Post-booster | 4643.1 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Post-Dose 2 | 3324.8 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Pre-booster | 1390.5 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Post-booster | 2911.6 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Post-Dose 2 | 1398.3 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Pre-booster | 420.1 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Post-booster | 1764.6 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Pre-booster | 794.3 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Post-booster | 173.3 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Post-Dose 2 | 1248.5 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Post-Dose 2 | 1735.5 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Pre-booster | 989.7 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Post-booster | 3598.5 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Post-Dose 2 | 225.3 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Pre-booster | 58.9 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Post-booster | 308 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Post-Dose 2 | 246 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Pre-booster | 56.7 Titers |
| Synflorix/GSK 2189242A-LD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Post-booster | 746.3 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Post-Dose 2 | 1197.9 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Post-Dose 2 | 2538.4 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Pre-booster | 2713.5 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Post-booster | 200 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Pre-booster | 1041 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Post-Dose 2 | 4936.6 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Post-booster | 2640.6 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Post-booster | 982.7 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Post-Dose 2 | 363.2 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Pre-booster | 420.7 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Pre-booster | 513.1 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Post-booster | 210.1 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Post-Dose 2 | 527.5 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Post-Dose 2 | 1823.7 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Post-booster | 110.4 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Pre-booster | 12.4 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Post-Dose 2 | 3621.8 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Pre-booster | 14.8 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Post-booster | 989.3 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Pre-booster | 1635.9 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Post-Dose 2 | 37.3 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Pre-booster | 76.4 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Post-booster | 6108 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Post-booster | 1385 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Post-Dose 2 | 186.2 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Pre-booster | 259.9 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Pre-booster | 99.4 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Post-booster | 5802.4 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Post-Dose 2 | 48.2 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Post-Dose 2 | 2580.7 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Pre-booster | 2622.4 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Post-booster | 348.2 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Pre-booster | 1725.8 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Post-Dose 2 | 3542.8 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Post-booster | 3729.8 Titers |
| Synflorix/GSK 2189242A-HD Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Post-booster | 5730.4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Pre-booster | 3844.5 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Pre-booster | 897.4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Post-Dose 2 | 1905.4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Pre-booster | 3450 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Post-Dose 2 | 6154.4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Post-booster | 1476 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Pre-booster | 1776.6 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Pre-booster | 766.4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Post-booster | 3094 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Post-booster | 1523.1 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Post-booster | 725.9 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Post-booster | 5296.1 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-18C, Post-booster | 2123.4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-14, Post-Dose 2 | 2487.6 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Pre-booster | 371.9 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Pre-booster | 87.8 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-7F, Post-booster | 7404.7 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Pre-booster | 625.4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Post-Dose 2 | 364.5 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6B, Post-Dose 2 | 915.3 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19A, Post-Dose 2 | 349.9 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Pre-booster | 478.9 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Post-booster | 260.7 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Post-Dose 2 | 3947.2 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Post-booster | 160.7 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Pre-booster | 19.3 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Post-Dose 2 | 90 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-19F, Post-Dose 2 | 1625.3 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Post-booster | 554.3 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Pre-booster | 17 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-6A, Pre-booster | 221.7 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-4, Post-Dose 2 | 1220.4 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-23F, Post-Dose 2 | 2502.5 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-1, Post-booster | 206.9 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-5, Post-Dose 2 | 42 Titers |
| Synflorix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | OPSONO-9V, Post-booster | 6016.6 Titers |