Vaccine response was defined as:

• for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32
• for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination.

The analysis was performed on subjects of 2 years and above from the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers were greater than or equal to ≥ 1:8 and ≥ 1:128. These analyses were performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.

The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and (≥) 2.0 μg/mL.

The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Antibody concentrations were presented as micrograms per milliliter (μg/mL).

The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).

The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Antibody titers are presented as geometric mean titers (GMTs).

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Antibody titers are presented as geometric mean titers (GMTs).

The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

Antibody titers are presented as GMTs. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 μg/mL.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

Antibody concentrations are presented as GMCs and expressed in μg/mL.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

Antibody titers are presented as geometric mean titers (GMTs).

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

The cut-off value for the hSBA titers was greater or equal to (≥) 1:4.

The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

Antibody titers are presented as geometric mean titers (GMTs).

The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

The cut-off value for the rSBA titers was ≥ 1:8. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

Antibody titers are presented as geometric mean titers (GMTs).

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.

Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from of 2 years and above from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from of 2 years and above from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.

Antibody titers are presented as geometric mean titers (GMTs).

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

Antibody titers are presented as geometric mean titers (GMTs).

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the Health Protection Agency (HPA) laboratory.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.

The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

Antibody titers are presented as geometric mean titers (GMTs).

The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) (1 - < 2 years of age and 2 - < 6 years of age groups) and 50 mm (6 - < 11 years of age groups) of injection site, respectively.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available for the vaccination.

Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. 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.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

SAEs assessed include 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 for whom data were available for the vaccination.

SAEs assessed include 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 for whom data were available for the vaccination.

SAEs assessed include 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 for whom data were available for the vaccination.

SAEs assessed include 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 for whom data were available for the vaccination.

SAEs assessed include 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 for whom data were available for the vaccination.