Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time frame: 1 month after booster dose (Month 10) - in primary study (105539)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time frame: Pre-additional dose at Month 34 in the current study (Month 34)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time frame: One week after vaccination at Month 34+7 days (Mth34+D7)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.

Time frame: Pre-vaccination (PRE/ Day 0)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time frame: One week after dose 1 (Day 7)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time frame: One month after dose 2 (Month 3)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and19A (ANTI-6A and19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

ANTI-PD concentrations were expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status was defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.

Time frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

ANTI-PD concentrations were expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status was defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.

Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.2 μg/mL.

Time frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL..

Time frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+ D7);

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.

Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.

Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.

Time frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7);

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Assessed local symptoms were pain, redness and swelling. Any = occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = crying when limb was moved/ spontaneously painful. Grade 3 Redness/ Swelling = Redness/ swelling at injection site greater than (\>) 30 millimeters (mm).

Time frame: During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group1 and the Synflorix Group2 and across the 2 doses in the Unprimed Group

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to and 7-10 days post- additional dose.

Time frame: Pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to, and 7-10 days post-dose 1.

Time frame: Pre-vaccination (PRE/ Day 0) and one week after dose 1 (Day 7)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

A serious adverse event (SAE) was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = occurrence of a SAE, regardless of relationship to vaccination.

Time frame: During the 31-day period following vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

An unsolicited AE was defined as 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 = occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.

Time frame: Within the 31-day (Days 0-30) period post vaccination, with the Synflorix™ vaccine, following the additional dose in the Synflorix group1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Assessed solicited general symptoms were drowsiness, irritability/ fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and Fever (rectal temperature ≥ 38.0 °C). Any = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 drowsiness = drowsiness that prevented normal everyday activities. Grade 3 Irr./Fuss. = crying that could not be comforted/ prevented normal everyday activities. Grade 3 loss of appetite = not eating at all. Grade 3 fever = rectal temperature \> 40.0°C.

Time frame: During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.

Time frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.

Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8

Time frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.

Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.