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Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Children Aged 12-23 Months at the Time of First Vaccination.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00985751
Enrollment
257
Registered
2009-09-28
Start date
2009-11-24
Completion date
2011-03-02
Last updated
2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Streptococcal

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

BIOLOGICALPneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)

Three doses will be administered intramuscularly, at Month 0, 2 and 6

BIOLOGICALPneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)

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

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Months to 23 Months
Healthy volunteers
Yes

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

MeasureTime frameDescription
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 vaccinationThe number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.

Secondary

MeasureTime frameDescription
Number of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsDuring 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 doseAn 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 ConcentrationsOne 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 SymptomsDuring 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 SerotypesOne 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 ActivityOne 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 ConcentrationsOne 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

ArmCount
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
Total257

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Overall StudyAdverse Event00001

Baseline characteristics

CharacteristicGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix GroupTotal
Age, Continuous17 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 Participants0 Participants1 Participants0 Participants2 Participants3 Participants
Race/Ethnicity, Customized
White-Caucasian/European heritage
51 Participants52 Participants51 Participants51 Participants49 Participants254 Participants
Sex: Female, Male
Female
25 Participants22 Participants23 Participants29 Participants28 Participants127 Participants
Sex: Female, Male
Male
26 Participants30 Participants29 Participants22 Participants23 Participants130 Participants

Adverse events

Event typeEG000
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 / 510 / 520 / 520 / 510 / 51
other
Total, other adverse events
47 / 5149 / 5249 / 5249 / 5149 / 51
serious
Total, serious adverse events
5 / 513 / 525 / 520 / 514 / 51

Outcome results

Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Synflorix GroupNumber of Subjects With Fever > 40.0°C (Rectal Temperature)0 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects With Fever > 40.0°C (Rectal Temperature)1 Participants
Comparison: Fever \>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine GSK 2189242A (pooled groups) versus Synflorix™ vaccine (GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.95% CI: [-6.1, 5.32]
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Synflorix GroupNumber of Subjects With Fever > 40.0°C (Rectal Temperature)0 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects With Fever > 40.0°C (Rectal Temperature)1 Participants
Comparison: Fever \>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine (GSK 2189242A) combined with Synflorix™ vaccine (pooled groups) versus Synflorix™ vaccine (Synflorix/GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.95% CI: [-6.1, 5.32]
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Synflorix GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Post-Dose 290.9 LU/mL
Synflorix GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Post-booster97.9 LU/mL
Synflorix GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Pre-booster89.1 LU/mL
Synflorix/GSK 2189242A GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Pre-booster118.2 LU/mL
Synflorix/GSK 2189242A GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Post-Dose 2100.4 LU/mL
Synflorix/GSK 2189242A GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Post-booster130.6 LU/mL
Synflorix/GSK 2189242A-LD GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Pre-booster734.6 LU/mL
Synflorix/GSK 2189242A-LD GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Post-Dose 21105.4 LU/mL
Synflorix/GSK 2189242A-LD GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Post-booster1882.6 LU/mL
Synflorix/GSK 2189242A-HD GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Post-Dose 2600.2 LU/mL
Synflorix/GSK 2189242A-HD GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Post-booster1474.6 LU/mL
Synflorix/GSK 2189242A-HD GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Pre-booster463 LU/mL
Synflorix GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Pre-booster691.8 LU/mL
Synflorix GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Post-Dose 2860 LU/mL
Synflorix GroupAntibody Concentrations to Protein D (Anti-PD)Anti-PD, Post-booster1963.8 LU/mL
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Synflorix GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Post-dose 2135703.5 LU/mL
Synflorix GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Pre-booster100811.4 LU/mL
Synflorix GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Post-booster224726.2 LU/mL
Synflorix GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Post-dose 230402.84 LU/mL
Synflorix GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Pre-booster24350.58 LU/mL
Synflorix GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Post-booster65584.24 LU/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Pre-booster23918.77 LU/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Post-booster77312.07 LU/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Post-dose 2148447.5 LU/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Post-booster305912.3 LU/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Post-dose 235043.91 LU/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Pre-booster96552.52 LU/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Post-dose 223438.06 LU/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Pre-booster14375.59 LU/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Post-dose 232436.07 LU/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Post-booster44123.43 LU/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Pre-booster19573.55 LU/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Post-booster32609.19 LU/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Post-dose 222141.18 LU/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Pre-booster29592.91 LU/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Post-booster85805.02 LU/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Post-booster36098.18 LU/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Pre-booster12721.01 LU/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Post-dose 257149.83 LU/mL
Synflorix GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Pre-booster4814.97 LU/mL
Synflorix GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Post-booster4553.43 LU/mL
Synflorix GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Pre-booster4654.16 LU/mL
Synflorix GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Post-booster5072.43 LU/mL
Synflorix GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-PhtD, Post-dose 23795.68 LU/mL
Synflorix GroupAnti-pneumococcal dPly and PhtD Proteins Antibody ConcentrationsAnti-dPly, Post-dose 23759.82 LU/mL
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Post-booster0.06 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Pre-booster0.06 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Post-Dose 20.05 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Pre-booster0.11 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Post-Dose 20.06 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Post-booster0.05 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Pre-booster0.05 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Post-Dose 20.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Post-booster0.13 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Pre-booster0.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Pre-booster0.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Post-booster0.05 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Pre-booster0.05 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Post-Dose 20.05 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Post-booster0.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Post-Dose 20.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Post-booster0.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Pre-booster0.05 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Post-Dose 20.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Post-Dose 20.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Post-Dose 20.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Post-booster0.07 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Pre-booster0.07 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Post-Dose 20.07 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Pre-booster0.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Post-booster0.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Post-booster0.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Pre-booster0.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Post-Dose 20.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Post-booster0.04 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Post-booster0.07 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Post-booster0.03 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Pre-booster0.03 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Post-Dose 20.03 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Post-Dose 20.1 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Pre-booster0.07 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Post-booster0.04 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Post-Dose 20.04 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Pre-booster0.03 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Post-booster0.04 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Post-Dose 20.03 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Pre-booster0.03 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Post-booster0.03 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Post-Dose 20.09 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Pre-booster0.11 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Post-booster0.16 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Post-Dose 20.04 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Pre-booster0.04 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Post-booster0.05 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Post-Dose 20.06 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Pre-booster0.05 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Post-booster0.07 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Post-Dose 20.04 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Pre-booster0.04 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Post-booster0.05 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Post-Dose 20.03 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Pre-booster0.04 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Post-booster0.04 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Post-Dose 20.05 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Pre-booster0.05 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Post-booster0.05 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Post-Dose 20.05 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Pre-booster0.05 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Post-booster0.05 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Post-Dose 20.03 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Pre-booster0.03 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Post-booster0.04 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Post-Dose 20.06 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Pre-booster0.06 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Post-booster0.07 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Post-Dose 20.03 µg/mL
Synflorix/GSK 2189242A GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Pre-booster0.04 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Post-Dose 20.32 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Pre-booster2.3 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Post-Dose 21.19 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Pre-booster2.6 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Post-booster5.26 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Post-booster7.74 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Post-Dose 25.03 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Pre-booster0.24 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Post-Dose 213.92 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Post-booster1.08 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Pre-booster4.94 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Pre-booster2.86 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Post-Dose 22.42 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Post-booster16.12 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Pre-booster1.44 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Post-Dose 28.6 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Post-booster0.53 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Pre-booster4.15 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Post-booster10.46 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Post-booster3.57 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Post-Dose 21.08 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Pre-booster1.08 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Pre-booster0.85 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Pre-booster0.71 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Post-Dose 22.81 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Post-booster2.76 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Post-booster3.13 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Post-Dose 22.5 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Post-booster1.92 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Pre-booster0.87 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Post-Dose 25.18 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Post-booster5.9 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Post-Dose 20.55 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Post-booster2.69 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Pre-booster0.39 µg/mL
Synflorix/GSK 2189242A-LD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Post-Dose 26.42 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Post-Dose 20.48 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Post-Dose 20.27 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Post-booster3.21 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Pre-booster2.36 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Post-Dose 22.08 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Pre-booster2.36 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Post-booster1.14 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Post-Dose 20.97 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Post-booster5.61 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Pre-booster1.26 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Post-booster5.25 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Post-booster6.62 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Post-Dose 22.49 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Post-booster3.45 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Pre-booster0.24 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Post-booster2.04 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Post-Dose 216.92 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Post-Dose 20.91 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Pre-booster2.3 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Pre-booster0.68 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Post-booster2.47 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Pre-booster5.51 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Pre-booster4.72 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Pre-booster0.75 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Pre-booster0.62 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Post-Dose 24.73 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Post-booster21.98 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Post-booster2.98 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Pre-booster0.42 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Post-Dose 22.41 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Post-booster14.38 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Post-Dose 210.08 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Post-Dose 26.6 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Post-Dose 23.78 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Post-booster0.56 µg/mL
Synflorix/GSK 2189242A-HD GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Pre-booster1.05 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Pre-booster4.79 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Pre-booster4.33 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Post-booster11.32 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Post-booster2.18 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Post-Dose 20.73 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Pre-booster0.51 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-23F, Post-booster1.47 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Pre-booster0.95 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Pre-booster1.18 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Post-Dose 20.31 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Pre-booster0.27 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6A, Post-booster0.58 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-9V, Post-Dose 21.55 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Post-Dose 20.93 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Pre-booster0.62 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Post-booster3.84 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19A, Post-booster2.06 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Post-booster4.65 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Post-booster1.08 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Post-Dose 22.13 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Pre-booster0.46 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Pre-booster0.73 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-1, Post-booster2.4 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Pre-booster2.14 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Post-Dose 25.67 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-6B, Post-Dose 20.55 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Pre-booster2.11 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-4, Post-booster5.18 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Post-booster5.98 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Pre-booster2.71 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-7F, Post-Dose 23.72 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Post-Dose 212.56 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-18C, Post-booster14.62 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-14, Post-Dose 24.63 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-19F, Post-Dose 28.87 µg/mL
Synflorix GroupAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody ConcentrationsAnti-5, Post-Dose 22.36 µg/mL
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Synflorix GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Pre-booster2441.1 Titers
Synflorix GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Post-Dose 23080 Titers
Synflorix GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Post-booster4332.4 Titers
Synflorix/GSK 2189242A GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Pre-booster2193.7 Titers
Synflorix/GSK 2189242A GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Post-Dose 22988.7 Titers
Synflorix/GSK 2189242A GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Post-booster5931.9 Titers
Synflorix/GSK 2189242A-LD GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Pre-booster1141.5 Titers
Synflorix/GSK 2189242A-LD GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Post-Dose 21278.9 Titers
Synflorix/GSK 2189242A-LD GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Post-booster1346.2 Titers
Synflorix/GSK 2189242A-HD GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Post-Dose 21814 Titers
Synflorix/GSK 2189242A-HD GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Post-booster2388.3 Titers
Synflorix/GSK 2189242A-HD GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Pre-booster1344.2 Titers
Synflorix GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Pre-booster995.9 Titers
Synflorix GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Post-Dose 2913.2 Titers
Synflorix GroupLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis ActivityAnti-Hem-dPly, Post-booster818.6 Titers
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Dose 215 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Dose 117 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Dose 221 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Booster0 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Booster18 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Booster19 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Dose 11 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Dose 21 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Dose 10 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Dose 20 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Dose 20 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Dose 18 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Dose 118 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Booster11 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Dose 211 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Booster0 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Dose 10 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Booster2 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Dose 10 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Dose 225 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Dose 222 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Booster20 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Dose 20 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Dose 115 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Booster8 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Booster0 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Dose 10 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Booster2 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Booster22 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Dose 120 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Dose 20 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Dose 10 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Booster3 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Dose 29 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Dose 15 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Dose 21 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Dose 131 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Booster18 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Booster3 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Dose 11 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Dose 132 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Dose 15 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Dose 119 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Dose 12 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Dose 224 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Dose 22 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Dose 223 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Dose 24 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Dose 218 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Dose 25 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Booster32 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Booster3 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Booster28 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Booster5 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Dose 12 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Dose 21 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Dose 117 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Booster1 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Dose 211 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Dose 14 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Dose 21 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Dose 128 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Booster15 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Booster26 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Dose 12 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Booster4 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Booster2 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Dose 123 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Dose 22 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Dose 227 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Booster22 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Dose 222 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Dose 227 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Dose 119 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Booster21 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Booster25 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Dose 23 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Booster3 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Redness Dose 12 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Pain Dose 126 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Dose 11 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Dose 216 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Dose 23 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Dose 125 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Swelling Booster13 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Booster1 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Dose 22 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsAny Redness Dose 224 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Pain Dose 14 Participants
Synflorix GroupNumber of Subjects Reporting Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling Booster3 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Dose 28 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Booster4 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Booster9 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Dose 10 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Dose 14 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Booster5 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Booster0 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Booster0 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Dose 10 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Dose 17 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Dose 116 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Dose 16 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Booster15 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Dose 24 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Dose 10 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Dose 16 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Dose 29 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Booster7 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Dose 23 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Dose 13 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Booster2 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Dose 20 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Booster0 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Dose 115 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Dose 212 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Dose 20 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Dose 21 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Booster13 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Booster6 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Dose 20 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Dose 212 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Booster8 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Dose 22 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Dose 12 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Dose 26 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Dose 121 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Dose 211 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Dose 212 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Dose 218 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Dose 116 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Dose 25 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Dose 20 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Dose 20 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Dose 211 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Booster4 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Dose 210 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Dose 10 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Booster0 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Dose 19 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Dose 10 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Booster10 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Dose 17 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Dose 113 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Booster11 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Dose 10 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Booster0 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Booster0 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Dose 15 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Booster17 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Dose 18 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Booster9 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Dose 11 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Dose 16 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Booster0 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Dose 12 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Booster3 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Booster13 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Dose 216 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Booster10 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Dose 26 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Dose 20 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Dose 20 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Booster1 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Dose 124 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Dose 10 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Dose 113 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Dose 131 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Dose 10 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Dose 117 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Dose 114 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Dose 11 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Dose 19 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Dose 114 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Dose 11 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Dose 17 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Dose 217 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Dose 20 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Dose 211 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Dose 222 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Dose 20 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Dose 217 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Dose 212 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Dose 20 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Dose 29 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Dose 28 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Dose 20 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Dose 25 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Booster18 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Booster0 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Booster11 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Booster26 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Booster0 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Booster15 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Booster13 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Booster7 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Booster10 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Booster0 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Booster7 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Dose 110 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Dose 210 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Dose 20 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Dose 20 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Booster5 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Dose 27 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Dose 215 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Booster12 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Dose 18 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Booster0 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Dose 10 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Dose 10 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Booster10 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Dose 112 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Booster2 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Booster17 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Dose 13 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Booster0 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Booster1 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Dose 10 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Booster13 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Dose 112 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Booster15 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Dose 116 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Dose 10 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Booster1 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Dose 127 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Dose 120 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Booster7 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Dose 29 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Dose 218 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Dose 20 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Dose 20 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Dose 25 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Dose 224 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Dose 29 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Booster1 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Dose 27 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Dose 221 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Dose 20 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Booster3 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Dose 114 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Dose 20 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Booster0 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Dose 223 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Dose 27 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Booster13 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Dose 27 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Dose 227 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Fever Dose 19 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Booster7 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Irritability Dose 114 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Booster17 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness Dose 126 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Fever Dose 10 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Dose 10 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Dose 213 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness Booster0 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite Booster8 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Fever Dose 112 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Dose 116 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Dose 10 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Booster11 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability Dose 21 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Dose 17 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite Booster6 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Booster1 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Booster19 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsAny Irritability Dose 123 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Dose 10 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness Dose 218 Participants
Synflorix GroupNumber of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite Dose 20 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Synflorix GroupNumber of Subjects With Serious Adverse Events (SAEs)5 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects With Serious Adverse Events (SAEs)3 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects With Serious Adverse Events (SAEs)5 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects With Serious Adverse Events (SAEs)0 Participants
Synflorix GroupNumber of Subjects With Serious Adverse Events (SAEs)4 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Synflorix GroupNumber of Subjects With Unsolicited Adverse Events (AEs)14 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects With Unsolicited Adverse Events (AEs)12 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects With Unsolicited Adverse Events (AEs)13 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects With Unsolicited Adverse Events (AEs)4 Participants
Synflorix GroupNumber of Subjects With Unsolicited Adverse Events (AEs)9 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Synflorix GroupNumber of Subjects With Unsolicited Adverse Events (AEs)25 Participants
Synflorix/GSK 2189242A GroupNumber of Subjects With Unsolicited Adverse Events (AEs)24 Participants
Synflorix/GSK 2189242A-LD GroupNumber of Subjects With Unsolicited Adverse Events (AEs)31 Participants
Synflorix/GSK 2189242A-HD GroupNumber of Subjects With Unsolicited Adverse Events (AEs)24 Participants
Synflorix GroupNumber of Subjects With Unsolicited Adverse Events (AEs)22 Participants
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Pre-booster4.5 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Post-Dose 24 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Post-booster11.8 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Pre-booster23.2 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Pre-booster12.6 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Post-booster4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Post-Dose 27 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Post-booster6.7 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Post-Dose 217.9 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Pre-booster21 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Post-Dose 215 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Pre-booster18.4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Pre-booster6 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Post-Dose 25.6 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Post-booster15.5 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Pre-booster56.7 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Post-Dose 25.8 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Post-booster5.2 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Post-booster4.9 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Pre-booster4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Post-booster26.1 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Post-booster173.5 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Post-booster32.3 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Pre-booster5 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Post-Dose 24 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Post-Dose 2734.6 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Post-Dose 226.5 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Post-Dose 29.3 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Post-booster6 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Post-Dose 221.1 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Pre-booster670.4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Post-booster68.6 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Post-Dose 24 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Pre-booster5.4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Pre-booster172.4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Post-booster936.8 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Post-Dose 27.3 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Post-Dose 24.6 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Post-booster46.7 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Post-Dose 250.1 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Pre-booster27.9 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Pre-booster172 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Post-Dose 211.9 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Post-booster137.6 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Post-Dose 28.9 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Post-booster6.3 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Post-booster17.3 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Pre-booster16.2 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Pre-booster9.4 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Post-booster17.8 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Post-Dose 25.7 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Post-booster106.7 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Post-Dose 24.7 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Pre-booster4.3 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Pre-booster136.3 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Pre-booster4 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Post-Dose 25.4 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Post-Dose 2107.8 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Post-booster5.1 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Pre-booster4.5 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Post-booster785.5 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Post-Dose 223.4 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Post-booster4.4 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Pre-booster61.6 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Pre-booster8 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Post-booster30.8 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Post-booster8.1 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Post-booster8 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Post-Dose 2807.4 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Pre-booster5 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Pre-booster462.3 Titers
Synflorix/GSK 2189242A GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Post-Dose 27.4 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Pre-booster2450.1 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Post-Dose 271.8 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Pre-booster23 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Post-booster169.5 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Post-Dose 21260.2 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Pre-booster247.9 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Post-booster1206.2 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Post-Dose 243.8 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Pre-booster12.8 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Post-booster99.3 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Post-Dose 2361.9 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Pre-booster213.8 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Post-booster804.6 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Post-Dose 25703.7 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Post-booster4109.3 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Post-Dose 24455 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Pre-booster2126.1 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Post-booster4643.1 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Post-Dose 23324.8 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Pre-booster1390.5 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Post-booster2911.6 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Post-Dose 21398.3 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Pre-booster420.1 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Post-booster1764.6 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Pre-booster794.3 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Post-booster173.3 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Post-Dose 21248.5 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Post-Dose 21735.5 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Pre-booster989.7 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Post-booster3598.5 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Post-Dose 2225.3 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Pre-booster58.9 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Post-booster308 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Post-Dose 2246 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Pre-booster56.7 Titers
Synflorix/GSK 2189242A-LD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Post-booster746.3 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Post-Dose 21197.9 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Post-Dose 22538.4 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Pre-booster2713.5 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Post-booster200 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Pre-booster1041 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Post-Dose 24936.6 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Post-booster2640.6 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Post-booster982.7 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Post-Dose 2363.2 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Pre-booster420.7 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Pre-booster513.1 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Post-booster210.1 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Post-Dose 2527.5 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Post-Dose 21823.7 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Post-booster110.4 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Pre-booster12.4 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Post-Dose 23621.8 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Pre-booster14.8 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Post-booster989.3 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Pre-booster1635.9 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Post-Dose 237.3 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Pre-booster76.4 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Post-booster6108 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Post-booster1385 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Post-Dose 2186.2 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Pre-booster259.9 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Pre-booster99.4 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Post-booster5802.4 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Post-Dose 248.2 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Post-Dose 22580.7 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Pre-booster2622.4 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Post-booster348.2 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Pre-booster1725.8 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Post-Dose 23542.8 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Post-booster3729.8 Titers
Synflorix/GSK 2189242A-HD GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Post-booster5730.4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Pre-booster3844.5 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Pre-booster897.4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Post-Dose 21905.4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Pre-booster3450 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Post-Dose 26154.4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Post-booster1476 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Pre-booster1776.6 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Pre-booster766.4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Post-booster3094 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Post-booster1523.1 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Post-booster725.9 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Post-booster5296.1 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-18C, Post-booster2123.4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-14, Post-Dose 22487.6 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Pre-booster371.9 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Pre-booster87.8 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-7F, Post-booster7404.7 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Pre-booster625.4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Post-Dose 2364.5 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6B, Post-Dose 2915.3 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19A, Post-Dose 2349.9 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Pre-booster478.9 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Post-booster260.7 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Post-Dose 23947.2 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Post-booster160.7 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Pre-booster19.3 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Post-Dose 290 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-19F, Post-Dose 21625.3 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Post-booster554.3 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Pre-booster17 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-6A, Pre-booster221.7 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-4, Post-Dose 21220.4 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-23F, Post-Dose 22502.5 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-1, Post-booster206.9 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-5, Post-Dose 242 Titers
Synflorix GroupOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive SerotypesOPSONO-9V, Post-booster6016.6 Titers

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026