The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.

Analysis was performed on FAS-Effectiveness (Month 7)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination,& who provided evaluable serum sample with enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Month 7.

The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 4 months after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.

Analysis was performed on FAS-Effectiveness (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum sample with the enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Month 10

The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 and 4 months after the 3-dose vaccination series were evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:8 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:8 dilution across all 110 strains.

Analysis was performed on FAS-Effectiveness (Months 7 & 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received subject ID & vaccination, & provided evaluable serum sample with the enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Months 7 & 10.

The mean percentage of US N. meningitidis serogroup B strains killed by each subject, at 1:4 and 1:8 dilutions before the 3-dose vaccination series, at Month 6 (PRE) and at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).

Analysis was performed on FAS-Effectiveness (Months 6, 7 & 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, got subject ID & vaccination, & provided serum sample with enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain before Month 6 & at Months 7 & 10

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA ≥ 1:8 against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).

Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) after the 3-dose vaccination series.

Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively.

Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup B test strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.

The LLQ cut off values for the strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6,8.9, 8 and 8.2 respectively.

Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 and whose immunogenicity assay result was available for at least one serogroup strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.

Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subjects D & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 3 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.

Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.

Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.

The immunogenicity of three doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at 1 and 4 months after the 3-dose vaccination series.

Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2, 39.6 and 14.7 respectively.

Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series. The LLQ cut off values for serogroups A, C, W and Y were 22.7,5.2,39.6 and 14.7 respectively.

Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 and whose immunogenicity assay result was available for at least one serogroup B strain

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.

Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 3 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.

Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.

Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.

Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup B test strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.

Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.

Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series.

Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.

Number of subjects reporting any solicited local or systemic AEs from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported. Assessed solicited local symptoms were induration, erythema and pain. Assessed solicited general symptoms were fatigue, myalgia, arthralgia, headache, fever, chills and loss of appetite. Other solicited data included prevention of pain/fever and treatment of pain/fever. Any = occurrence of the symptom regardless of intensity grade.

Analysis was performed on Safety Set (solicited AEs & other solicited reactions)-included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & a study vaccination, & provided post-vaccination reactogenicity data.

The number of subjects reporting unsolicited AEs after any vaccination is reported. 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.

Analysis was performed on Safety set (unsolicited AEs)- included all screened subjects who provided informed consent & demographic and/or baseline screening assessments, received a subject ID and a study vaccination, and had post-vaccination unsolicited adverse event records.

The number of subjects reporting any SAEs, medically-attended AEs and AEs leading to premature withdrawal during the entire study period is reported. SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. MAEs 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 was defined as the occurrence of any unsolicited AE regardless of intensitygrade or relation to vaccination.

Analysis was performed on Safety Set (overall)- included all screened subjects who provide informed consent and demographic and/or baseline screening assessments, received a subject ID and a study vaccination, and have either post-vaccination reactogenicity data or post-vaccination unsolicited adverse event records.