The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 2 and 3 and are considered final in Company's judgement.

Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.

Antibody levels against N. meningitidis serogroups A, C, W and Y in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of subjects with hSBA ≥ 8.

Analysis was performed on Full Analysis Set immunogenicity persistence population set- all subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1 in this study) and whose assay result was available for at least one strain.

Antibody levels against N. meningitidis serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Analysis was performed on Full Analysis Set immunogenicity persistence population set- all subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1 in this study) and whose assay result was available for at least one strain.

GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Analysis was performed on Full Analysis Set immunogenicity persistence population set- all subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1 in this study) and whose assay result was available for at least one strain.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 6 and 7 and are considered final in Company's judgement.

Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.

Immune response against N. meningitidis serogroups A, C, W and Y 30 days after a single dose of MenABCWY+OMV in subjects who previously vaccinated subjects, and in Naïve subjects of similar age, as measured by the percentages of subjects with hSBA ≥ 8.

Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 31- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay result was available for at least one strain.

Immune response against N. meningitidis serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in Naïve subjects of similar age, as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 31- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay result was available for at least one strain.

GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 31- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay result was available for at least one strain.

GMRs as measure of the immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 31- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay result was available for at least one strain.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 12 and 13 and are considered final in Company's judgement.

Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 12 and 13 and are considered final in Company's judgement.

Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.

Kinetics of immune response following 1 dose of MenABCWY+OMV in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY, at Days 1, 4, 8, 31, 34, 38 and 61, as measured by the percentages of subjects with hSBA ≥ 8.

Analysis was performed on Full Analysis Set immunogenicity kinetics population set- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay result was available for at least one strain.

Kinetics of immune response against N. meningitidis serogroup B test strains in previously vaccinated subjects, at Days 1, 4, 8, 31, 34, 38 and 61, as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Kinetics of immune response against N. meningitidis serogroup B test strains in previously vaccinated subjects, at Day 1, 4, 8, 31, as measured by the percentages of Subjects with hSBA ≥ 5. The data were reported based on the FAS immunogenicity kinetics population set.

GMTs at Day 1, 4, 8, 31 as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY. This outcome measure reports data only for the MenABCWY+OMV and MenACWY Groups as per protocol. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Analysis was performed on Full Analysis Set immunogenicity kinetics population set- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay result was available for at least one strain.

GMTs at Day 1, 31, 34, 38, 61 as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who were not primed with any meningococcal vaccine (i.e., Naïve Group). This outcome measure reports data for only the Naïve Group as per protocol. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Analysis was performed on Full Analysis Set immunogenicity kinetics population set- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay result was available for at least one strain.

GMRs as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Analysis was performed on Full Analysis Set immunogenicity kinetics population set- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay result was available for at least one strain.

GMRs as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Analysis was performed on Full Analysis Set immunogenicity kinetics population set- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay result was available for at least one strain.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 19 and 20 and are considered final in Company's judgement.

Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.

Immunogenicity against N. meningitidis serogroup A, C, W and Y following 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61, as measured by percentages of subjects with hSBA ≥ 8.

Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 61- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post second vaccination and whose assay result was available for at least one serogroup/ test strain

Immunogenicity against N. meningitidis serogroup B test strains following 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61, as measured by percentages of subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 61- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post second vaccination and whose assay result was available for at least one serogroup/ test strain.

GMTs as measure of the immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 61- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post second vaccination and whose assay result was available for at least one serogroup/ test strain.

GMRs as measure of the immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 61- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post second vaccination and whose assay result was available for at least one serogroup/ test strain.

Any solicited and unsolicited AEs reported within 30 minutes after each vaccination. Assessed solicited local symptoms were: Erythema and Induration. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site. Assessed solicited general symptoms were: Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of Pain and/or Fever and Treatment of Pain and/or Fever. Any = occurrence of the symptom regardless of intensity grade. Note: There were no unsolicited AEs reported within 30 minutes after vaccination.

Analysis was performed on Solicited safety Set- included all subjects in the Full Analysis Set Immunogenicity population who provided post-vaccination safety data.

Assessed solicited local symptoms were Erythema, Induration and Pain. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site.

Analysis was performed on Solicited safety Set- included all subjects in the Full Analysis Set Immunogenicity population who provided post-vaccination safety data.

Assessed solicited systemic symptoms were Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of pain and/or fever and Treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.

Analysis was performed on Solicited safety Set- included all subjects in the Full Analysis Set Immunogenicity population who provided post-vaccination safety data.

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. Possibly or Probably related = AE assessed by the investigator as related to the vaccination.

Analysis was performed on Unsolicited Safety Set- included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.

Medically attended AEs = were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) = Occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination.

Analysis was performed on Unsolicited Safety Set- included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.

The number of subjects who reported unsolicited AEs leading to premature withdrawal from study after any vaccination.

Analysis was performed on Unsolicited Safety Set- included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.

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. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Possibly or probably related SAE(s) = SAE(s) assessed by the investigator as related to the vaccination.

Analysis was performed on Unsolicited Safety Set- included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.