Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in.

The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants "Pooled Group I + II") and Full term group (i.e. "Synflorix™ + Infanrix™ Hexa Group III").

Solicited local symptoms assessed included 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 greater than (>) 30 millimeters (mm). "Any" was defined as incidence of the specified symptom regardless of intensity.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in.

The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants "Pooled Group I + II") and Full term group (i.e. "Synflorix™ + Infanrix™ Hexa Group III").

Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in.

The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants "Pooled Group I + II") and Full term group (i.e. "Synflorix™ + Infanrix™ Hexa Group III").

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" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants "Pooled Group I + II") and Full term group (i.e. "Synflorix™ + Infanrix™ Hexa Group III").

Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants "Pooled Group I + II") and Full term group (i.e. "Synflorix™ + Infanrix™ Hexa Group III").

Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants "Pooled Group I + II") and Full term group (i.e. "Synflorix™ + Infanrix™ Hexa Group III").

The cut-off for the assay was ≥ 0.20 microgram per mililiter (μg/ mL).

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off for the assay was ≥ 0.05 microgram per mililiter (μg/mL).

The analysis was performed on the ATP cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off for the assay was ≥ 8

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8.

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off for the assay was ≥ 8.

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off for the assay was ≥ 100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL).

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seroprotection status was defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off for the assay was ≥ 0.15 microgram per milliliter (μg/mL).

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off for the assay was ≥ 1.0 microgram per milliliter (μg/mL).

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seroprotection status was defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off for the assay was ≥ 5 ELISA unit per milliliter (EL.U/mL).

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ 5 EL.U/mL.

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off for the assay was ≥ 10 milli-international units per milliliter (mIU/mL).

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seroprotection status was defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off for the assay was ≥ 8.

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seroprotection status was defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8.

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Vaccine response to PT, FHA and PRN was defined as appearance of antibodies in subjects who are initially seronegative (S-), or at least maintenance of pre-vaccination antibody concentrations in those who are initially seropositive (S+). For the SYNFLORIX™ + INFANRIX™ HEXA GROUP I, no subjects presented initial seropositivity for PT and PRN antigens.

The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.