The non-inferiority of the Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant (MenABCWY) vaccine to Meningococcal (group B) multicomponent recombinant adsorbed (Bexsero) vaccine, administered according to 0, 2 month schedule, as measured by hSBA GMTs against N.meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, is reported. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. This outcome measure was evaluated in the rMenB_0_2 and ABCWY_ 0_2 Groups.

Analysis was done on Per Protocol Set (PPS)-Month 3, which included all screened subjects who received a study vaccination, provided evaluable serum samples at pre- & post-vaccination, with results available for at least 1 serogroup B test strain & who was not excluded due to protocol deviations/other reasons defined before unblinding/analysis

The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule was compared with those administered according to 0, 2 months schedule, as measured by hSBA GMTs against N. meningitidis serogroup B test strains and serogroups A,C, W and Y at 1 month after the last meningococcal vaccination. The B test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. This outcome measure was evaluated in the ABCWY_ 0_2 and ABCWY_0_2_6 Groups. 1 month post last meningococcal vaccination corresponds to Month 3 for ABCWY_0_2 Group and Month 7 for ABCWY_0_2_6 Group.

Analysis was done on the FAS-1 month after the last meningococcal vaccination.All subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at pre- & at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.

The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 month schedule, was compared with those, administered according to 0, 2 month schedule, as measured by the percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination.

Analysis was done on the FAS-1 month after the last meningococcal vaccination.All subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at pre- & at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.

The immunogenicity of MenABCWY vaccine, administered according to 0, 2 months schedule, was compared with those, administered according to 0, 1 month, 0, 6 month and 0, 11 month schedules as measured by hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the second meningococcal vaccination.

Analysis was done on the FAS- 1 month after last meningococcal vaccination, which included all screened subjects who provided informed consent, received a study vaccination & provided evaluable serum samples at 1 month after last vaccination whose results were available for atleast 1 serogroup or B strain

A sufficient immune response following Bexsero vaccine, administered according to 0, 2 month schedule, as measured by the percentage of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, was to be demonstrated. Criterion: the immune response was to be considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titers ≥ LLQ was greater than 75% for each of the four serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.

Analysis was done on Full Analysis Set(FAS)- 1 month post meningococcal vaccination. Subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at pre- & at 1 month post last meningococcal vaccination whose result is available for at least one A,C,W or Y serogroup or serogroup B test strain.

The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule was compared with those administered according to 0, 6 months schedule, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the last meningococcal vaccination.

Analysis was done on the FAS- 1 month after last meningococcal vaccination, which included all screened subjects who provided informed consent, received a study vaccination & provided evaluable serum samples at 1 month after last vaccination whose results were available for atleast 1 serogroup or B strains

The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 month schedule, was compared with those, administered according to 0, 6 month schedule, as measured by the percentages of subjects with hSBA titers ≥ LLQ against serogroups A, C, W and Y and serogroup B test strains at 1 month after the last meningococcal vaccination.

Analysis was done on the FAS- 1 month after last meningococcal vaccination, which included all screened subjects who provided informed consent, received a study vaccination & provided evaluable serum samples at 1 month after last vaccination whose results were available for atleast 1 serogroup or B strain

The immunogenicity of MenABCWY vaccine, administered according to 0, 2 month schedule, was compared with those, administered according to 0, 1 month, 0, 6 month and 0, 11 month schedules, as measured by the percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the second meningococcal vaccination.

Analysis was done on the FAS- 1 month after last meningococcal vaccination, which included all screened subjects who provided informed consent, received a study vaccination & provided evaluable serum samples at 1 month after last vaccination whose results were available for atleast 1 serogroup or B strain

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the adjusted hSBA GMTs against serogroups A,C, W and Y and serogroup B test strains was assessed.

Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against NZ98/254 B strain was assessed.

Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M14459 B strain was assessed.

Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M07-0241084 B strain was assessed.

Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against 96217 B strain was assessed.

Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against A human serogroup was assessed.

Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against C human serogroup was assessed.

Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against W human serogroup was assessed.

Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against Y human serogroup was assessed.

Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for at least one serogroup or serogroup B test strain.

The kinetic of immune response (at Months 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with two-, three- and four-fold titer rise against serogroups A, C, W and Y and serogroup B test strains was assessed. The two/three/four fold titer rise is defined as: a) for subjects with prevaccination hSBA titers ≤ LLQ, a postvaccination hSBA ≥ 2/3/4 LLQ; b) for subjects with a prevaccination hSBA titers ≥ LLQ, an increase of at least 2/3/4 times of the prevaccination hSBA titer.

Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.

The area under the curve for percentage of subjects with hSBA titers ≥ LLQ for all serogroups (A, C, W and Y) and for all serogroup B test strains (M14459, 96217, NZ98/254 and M07-0241084) was summarized overall (from Month 0 to Month 13) and by period (from Month 0 to Month 2, Month 2 to Month 3, Month 3 to Month 7 and Month 7 to Month 13) by vaccine groups. It was computed as the sum of the trapezoidal areas and the time unit used was the month. AUC 0_13 = (r0+r2)(2-0)/2 + (r2+r3)(3-2)/2 + (r3+r7)(7-3)/2 + (r7+r13)(13-7)/2 with ri = percentages of subjects with both hSBA titers >= LLQ against N. meningitis for all serogroups A, C, W and Y and for all serogroup B test strains at Month 1.

Analysis was done on the FAS Month 13 Over Time. All subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.

Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after each vaccination. Assessed solicited symptoms were Pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C).

Analysis was done on subjects in Solicited Safety Set - all screened subjects who provided informed consent & provided demographic &/or other baseline screening measurements, regardless of the subject's randomization & vaccination status in the trial, received a subject ID,provided post-vaccination reactogenicity data & received a study vaccination

An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a participant and/or parent/legal guardian who has signed the informed consent. Number of participants reporting any unsolicited AE within 30 minutes after each vaccination.

Analysis was done on subjects in the Unsolicited Safety Set-all screened subjects who provided informed consent & demographic &/or other baseline screening measurements, regardless of the subject's randomization & vaccination status, received a subject ID, received a study vaccination & have either post-vaccination reactogenicity data or records.

The number of participants reporting unsolicited AEs and possibly or probably related unsolicited AEs were assessed.

Analysis was done on subjects in the Unsolicited Safety Set -all screened subjects who provided informed consent & provided demographic &/or other baseline screening measurements, regardless of the subject's randomization & vaccination status, received a subject ID, received a study vaccination & have either post-vaccination reactogenicity records.

Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported.

Analysis was done on all subjects in the Solicited Safety Set-all screened subjects who provided informed consent & provided demographic &/ other baseline screening measurements,regardless of the subject's randomization & vaccination status in the trial,received a subject ID,provided post-vaccination reactogenicity data & received study vaccination

The number of participants reporting any SAE, possibly or probably related SAE(s), medically-attended AEs, AEs leading to premature withdrawal, AEs leading to death, AEs leading to hospitalization and AEs leading to dose reduction, interruption and delay in study vaccination during the entire study period is reported.

Analysis was done on all subjects in the Unsolicited Safety Set-all screened subjects who provided informed consent & provided demographic &/or other baseline screening measurements, regardless of the subject's randomization & vaccination status, received a subject ID, received a study vaccination and have post-vaccination unsolicited AE records.