Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A

Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame: One month after the primary vaccination (Month 3)

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at Month 3.

Antibodies have been assessed against the following 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), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (\<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame: One month after primary vaccination (Month 3)

Population: The analysis was performed on the According To Protocol (ATP) immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at Month 3.

Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.

Anti-DT and anti-TT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). Seroprotection status was defined as anti-DT or anti-TT antibody concentration ≥ than 0.1 IU/mL.

Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Tritanrix-HepB/Hib vaccine, for whom data concerning immunogenicity outcomes and assay results for antibodies against diphtheria and tetanus toxoids were available at the specified time point.

Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame: Prior to (Month 0) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against protein D were available at the specified time point.

Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against protein D were available at the specified time point.

Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against protein D were available at the specified time point.

Antibodies have been assessed against the following 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), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame: Prior to the primary vaccination (Month 0), prior to (Month 8) and one month after (Month 9) booster vaccination

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at the specified time point.

Antibodies have been assessed against the following 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), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at the specified time point.

Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 15 EL.U/mL.

Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Tritanrix-HepB/Hib vaccine, for whom data concerning immunogenicity outcomes and assay results for antibodies against Bordetella pertussis were available at the specified time point.

Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.

Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.

Antibodies have been assessed against the following 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), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at the specified time point.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Time frame: During the 4-day (Days 0-3) post-booster vaccination period

Population: The analysis was performed on the Total Vaccinated cohort for the booster epoch, which included all booster vaccinated subjects who completed their symptoms sheet. Note that no data are reported for the 12-23 months of age groups as they were not administered any vaccine during the booster phase.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Time frame: During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort for the primary epoch, which included all vaccinated subjects who completed their symptoms sheet for the respective dose. Note that dose 3 rows are not applicable for subjects from the 7-11 and 12-23 months of age groups as they only received a 2-dose primary vaccination.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame: During the 4-day (Days 0-3) post-booster vaccination period

Population: The analysis was performed on the Total Vaccinated cohort for the booster epoch, which included all booster vaccinated subjects who completed their symptoms sheet. Note that no data are reported for the 12-23 months of age groups as they were not administered any vaccine during the booster phase.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame: During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort for the primary epoch, which included all vaccinated subjects who completed their symptoms sheet for the respective dose. Note that dose 3 rows are not applicable for subjects from the 7-11 and 12-23 months of age groups as they only received a 2-dose primary vaccination.

An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame: Within the 31-day (Days 0-30) post-primary and post-booster vaccination period

Population: The analysis was performed on the Total Vaccinated cohort for the primary and booster epochs, which included all vaccinated subjects who received at least one dose of primary vaccination and the booster dose of study vaccine, respectively. Note that subjects from the 12-23 months of age groups did not participate in the Booster Epoch.

Serious adverse events (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 from Month 0 to Month 9

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccination.

Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom opsonophagocytic activity assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.

Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom opsonophagocytic activity assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.

Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom opsonophagocytic activity assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.

Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom opsonophagocytic activity assay results for antibodies against at least one vaccine antigen component were available at the specified time point.

Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom opsonophagocytic activity assay results for antibodies against at least one vaccine antigen component were available at the specified time point.

Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and opsonophagocytic activity assay results for antibodies against at least one vaccine antigen component were available at the specified time point.