hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.

hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.

hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.

hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.

hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.

hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.

Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.

Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.

Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.

The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥2.0 μg/mL.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.

Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Analysis was performed on Total cohort at Year 1 which included all subjects vaccinated in the primary study and who came back to the visit at Year 1.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Analysis was performed on Total cohort at Year 3 which included all subjects vaccinated in the primary study and who came back to the visit at Year 3.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Analysis was performed on Total cohort at Year 5 which included all subjects vaccinated in the primary study and who came back to the visit at Year 5.

The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8.

Analysis was performed on the ATP cohort for immunogenicity at Month 61 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 the primary (naïve control group) or booster vaccination.

Titers are given as GMTs for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.

Analysis was performed on the ATP cohort for immunogenicity at Month 61 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 the primary (naïve control group) or booster vaccination.

Vaccine response was defined as:

For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination.

Analysis was performed on the ATP cohort for immunogenicity at Month 61 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 the primary (naïve control group) or booster vaccination.

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).

Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.

Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.

Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.

Unsolicited AE covers any AE 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.

Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.

Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.

Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.