Trial Outcomes & Findings for Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months. (NCT NCT00310817)

Results Overview

Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

623 participants

Primary outcome timeframe

28 days after first vaccination.

Results posted on

2015-11-06

Participant Flow

Subjects were enrolled at one center in Finland and in two centers in Poland.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	MenACWY-CRM(Ad+) 12 to 35 Months Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.	MenACWY-CRM(Ad-) 12 to 35 Months Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.	MenACWY-CRM(Ad-) 36 to 59 Months Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.	MenACWY-PS (36 to 59 Months) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
Overall Study STARTED	207	206	128	82
Overall Study COMPLETED	196	198	120	74
Overall Study NOT COMPLETED	11	8	8	8

Reasons for withdrawal

Reasons for withdrawal
Measure	MenACWY-CRM(Ad+) 12 to 35 Months Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.	MenACWY-CRM(Ad-) 12 to 35 Months Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.	MenACWY-CRM(Ad-) 36 to 59 Months Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.	MenACWY-PS (36 to 59 Months) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
Overall Study AE or Death	3	1	0	0
Overall Study Withdrawal by Subject	1	4	6	7
Overall Study Lost to Follow-up	2	1	0	0
Overall Study Inappropriate Enrollment	1	0	1	0
Overall Study Protocol Violation	1	1	1	1
Overall Study Unable to classify	3	1	0	0

Baseline Characteristics

Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenACWY-CRM(Ad+) 12 to 35 Months n=207 Participants Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.	MenACWY-CRM(Ad-) 12 to 35 Months n=206 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.	MenACWY-CRM(Ad-) 36 to 59 Months n=128 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=82 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.	Total n=623 Participants Total of all reporting groups
Age, Continuous	24.1 Months STANDARD_DEVIATION 6.4 • n=5 Participants	23.7 Months STANDARD_DEVIATION 6.2 • n=7 Participants	45.1 Months STANDARD_DEVIATION 6.7 • n=5 Participants	44.7 Months STANDARD_DEVIATION 6.4 • n=4 Participants	31.0 Months STANDARD_DEVIATION 11.8 • n=21 Participants
Sex: Female, Male Female	110 Participants n=5 Participants	107 Participants n=7 Participants	68 Participants n=5 Participants	44 Participants n=4 Participants	329 Participants n=21 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	99 Participants n=7 Participants	60 Participants n=5 Participants	38 Participants n=4 Participants	294 Participants n=21 Participants

PRIMARY outcome

Timeframe: 28 days after first vaccination.

Population: Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.

Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=101 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=81 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenY (Baseline; N=100,79)	10 percentages of subjects Interval 5.0 to 18.0	11 percentages of subjects Interval 5.0 to 21.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenY (28 days after 1st vaccination; N=100,79)	77 percentages of subjects Interval 68.0 to 85.0	67 percentages of subjects Interval 56.0 to 77.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenA (Baseline; N=101,80)	2 percentages of subjects Interval 0.0 to 7.0	1 percentages of subjects Interval 0.032 to 7.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenA (28 days after 1st vaccination; N=101,80)	75 percentages of subjects Interval 66.0 to 83.0	55 percentages of subjects Interval 43.0 to 66.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenC (Baseline; N=99,79)	14 percentages of subjects Interval 8.0 to 23.0	10 percentages of subjects Interval 4.0 to 19.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenC (28 days after 1st vaccination; N=99,79)	60 percentages of subjects Interval 49.0 to 69.0	52 percentages of subjects Interval 40.0 to 63.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenW (Baseline; N=100,81)	17 percentages of subjects Interval 10.0 to 26.0	19 percentages of subjects Interval 11.0 to 29.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenW (28 days after 1st vaccination; N=100,81)	91 percentages of subjects Interval 84.0 to 96.0	67 percentages of subjects Interval 55.0 to 77.0	—	—

SECONDARY outcome

Timeframe: 28 days after first vaccination

Population: Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.

Immune response of one dose of MenACWY-CRM(Ad-) compared to that of a MenACWY-PS vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentages of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=101 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=81 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenA (Baseline)	2 percentages of subjects Interval 0.0 to 7.0	0 percentages of subjects Interval 0.0 to 5.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenA (28 days after 1st vaccination)	61 percentages of subjects Interval 51.0 to 71.0	39 percentages of subjects Interval 28.0 to 50.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenC (Baseline; N=99,79)	5 percentages of subjects Interval 2.0 to 11.0	8 percentages of subjects Interval 3.0 to 16.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenC (28 days after 1st vaccination; N=99,79)	54 percentages of subjects Interval 43.0 to 64.0	39 percentages of subjects Interval 28.0 to 51.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenW (Baseline; N=100,81)	15 percentages of subjects Interval 9.0 to 24.0	14 percentages of subjects Interval 7.0 to 23.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenW (28 days after 1st vaccination; N=100,81)	84 percentages of subjects Interval 75.0 to 91.0	59 percentages of subjects Interval 48.0 to 70.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenY (Baseline; N=100,79)	7 percentages of subjects Interval 3.0 to 14.0	6 percentages of subjects Interval 2.0 to 14.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenY (28 days after 1st vaccination; N=100,79)	67 percentages of subjects Interval 57.0 to 67.0	57 percentages of subjects Interval 45.0 to 68.0	—	—

SECONDARY outcome

Timeframe: 28 days after first vaccination

Population: Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.

Immune response of one dose of MenACWY-CRM(Ad-) vaccine compared with that of one dose of MenACWY-PS vaccine, 28 days after administration in subjects 36-59 months of age, as measured by hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=101 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=81 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenC (28 days after 1st vaccination; N=99,79)	7.12 titers Interval 5.45 to 9.3	7.16 titers Interval 5.31 to 9.65	—	—
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenA (Baseline; N=101,80)	2.06 titers Interval 2.02 to 2.1	2.03 titers Interval 1.98 to 2.07	—	—
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenA (28 days after 1st vaccination; N=101,80)	15 titers Interval 11.0 to 20.0	6.82 titers Interval 4.89 to 9.53	—	—
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenC (Baseline; N=99,79)	2.42 titers Interval 2.22 to 2.65	2.54 titers Interval 2.3 to 2.8	—	—
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenW (Baseline; N=100,81)	3.05 titers Interval 2.63 to 3.53	3.14 titers Interval 2.66 to 3.7	—	—
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenW (28 days after 1st vaccination; N=100,81)	24 titers Interval 18.0 to 31.0	12 titers Interval 8.68 to 16.0	—	—
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenY (Baseline; N=100,79)	2.42 titers Interval 2.21 to 2.66	2.46 titers Interval 2.21 to 2.73	—	—
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenY (28 days after 1st vaccination; N=100,79)	21 titers Interval 15.0 to 29.0	14 titers Interval 9.99 to 21.0	—	—

SECONDARY outcome

Timeframe: 6 months after first vaccination and 12 months after first vaccination

Population: Analysis was done on PP dataset -subset of subjects in the MITT population for the evaluation of immunogenicity after the 1st dose of either MenACWY Ad+/PS vaccine, provided evaluable serum samples at day 169 day 358 and had no major protocol deviation.

Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=48 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=45 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=32 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=36 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenA	2.84 titers Interval 2.17 to 3.73	2.51 titers Interval 1.9 to 3.32	2.96 titers Interval 2.03 to 4.32	2.78 titers Interval 1.95 to 3.96
hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenC (N=47,45,32,36)	5.06 titers Interval 3.43 to 7.46	4.3 titers Interval 2.89 to 6.39	3.33 titers Interval 2.04 to 5.43	3.89 titers Interval 2.45 to 6.16
hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenW (N=47,45,32,35)	22 titers Interval 14.0 to 33.0	20 titers Interval 13.0 to 30.0	9.98 titers Interval 5.86 to 17.0	13 titers Interval 7.76 to 21.0
hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenY (N=47,45,32,36)	11 titers Interval 7.14 to 18.0	18 titers Interval 11.0 to 29.0	6.44 titers Interval 3.86 to 11.0	5.29 titers Interval 3.26 to 8.57

SECONDARY outcome

Timeframe: 6 months after first vaccination and 12 months after first vaccination

Population: Analysis was done on PP dataset- subjects who received a dose of either MenACWY-CRM(Ad+) or MenACWY(Ad-) vaccine or MenACWY-PS vaccine at either 6 or 12 months from the first vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the first vaccine dose and had no major protocol deviation.

Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=48 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=45 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=32 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=36 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenA (Day 169)	23 percentages of subjects Interval 12.0 to 37.0	13 percentages of subjects Interval 5.0 to 27.0	19 percentages of subjects Interval 7.0 to 36.0	14 percentages of subjects Interval 5.0 to 29.0
Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenC (Day 169; N=47,45,32,36)	45 percentages of subjects Interval 30.0 to 60.0	42 percentages of subjects Interval 28.0 to 58.0	28 percentages of subjects Interval 14.0 to 47.0	22 percentages of subjects Interval 10.0 to 39.0
Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenW (Day 169; N=47,45,32,36)	94 percentages of subjects Interval 82.0 to 99.0	84 percentages of subjects Interval 71.0 to 94.0	56 percentages of subjects Interval 38.0 to 74.0	61 percentages of subjects Interval 43.0 to 77.0
Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenY (Day 169; N=47,45,32,36)	70 percentages of subjects Interval 55.0 to 83.0	80 percentages of subjects Interval 65.0 to 90.0	53 percentages of subjects Interval 35.0 to 71.0	42 percentages of subjects Interval 26.0 to 59.0

SECONDARY outcome

Timeframe: 6 months after first vaccination and 12 months after first vaccination

Population: Analysis was done on PP dataset -subjects in the MITT who received a dose of either MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-) or MenACWY-PS vaccine at either 6 or 12 months from the 1st vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the 1st vaccine dose and had no major protocol deviation.

Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=48 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=45 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=32 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=36 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenA	10 percentages of subjects Interval 3.0 to 23.0	9 percentages of subjects Interval 2.0 to 21.0	16 percentages of subjects Interval 5.0 to 33.0	14 percentages of subjects Interval 5.0 to 29.0
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenC (N=47,45)	32 percentages of subjects Interval 19.0 to 47.0	24 percentages of subjects Interval 13.0 to 40.0	19 percentages of subjects Interval 7.0 to 36.0	19 percentages of subjects Interval 8.0 to 36.0
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age MenW (N=47,45)	77 percentages of subjects Interval 62.0 to 88.0	76 percentages of subjects Interval 60.0 to 87.0	53 percentages of subjects Interval 35.0 to 71.0	56 percentages of subjects Interval 38.0 to 72.0
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age Men Y (N=47,45)	60 percentages of subjects Interval 44.0 to 74.0	64 percentages of subjects Interval 49.0 to 78.0	38 percentages of subjects Interval 21.0 to 56.0	36 percentages of subjects Interval 21.0 to 54.0

SECONDARY outcome

Timeframe: 21 days after second vaccination

Population: Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.

Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured 21 days after the booster dose by hSBA GMT against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=48 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=45 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=32 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=36 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age MenA	51 titers Interval 35.0 to 75.0	149 titers Interval 99.0 to 222.0	72 titers Interval 48.0 to 108.0	116 titers Interval 79.0 to 169.0
hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age MenC	129 titers Interval 83.0 to 200.0	472 titers Interval 301.0 to 739.0	7.33 titers Interval 4.22 to 13.0	17 titers Interval 9.92 to 28.0
hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age MenW	371 titers Interval 256.0 to 535.0	1120 titers Interval 769.0 to 1632.0	38 titers Interval 23.0 to 64.0	82 titers Interval 50.0 to 134.0
hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age MenY	247 titers Interval 168.0 to 364.0	911 titers Interval 613.0 to 1353.0	22 titers Interval 13.0 to 38.0	24 titers Interval 14.0 to 40.0

SECONDARY outcome

Timeframe: 21 days after second vaccination

Population: Analysis was done on PP dataset- subjects who received a dose of either MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-)vaccine or MenACWY-PS vaccine at either 6 or 12 months from the first vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the first vaccine dose and had no major protocol deviation.

Booster effect of a second dose of MenACWY-CRM(-Ad) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=48 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=45 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=32 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=36 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age MenC (N=47,45)	100 percentages of subjects Interval 92.0 to 100.0	100 percentages of subjects Interval 92.0 to 100.0	44 percentages of subjects Interval 26.0 to 62.0	56 percentages of subjects Interval 38.0 to 72.0
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age MenA	92 percentages of subjects Interval 80.0 to 98.0	98 percentages of subjects Interval 88.0 to 100.0	100 percentages of subjects Interval 89.0 to 100.0	94 percentages of subjects Interval 81.0 to 99.0
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age MenW (N=47,45)	100 percentages of subjects Interval 92.0 to 100.0	100 percentages of subjects Interval 92.0 to 100.0	97 percentages of subjects Interval 84.0 to 100.0	92 percentages of subjects Interval 78.0 to 98.0
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age MenY (N=47,45)	100 percentages of subjects Interval 92.0 to 100.0	100 percentages of subjects Interval 92.0 to 100.0	75 percentages of subjects Interval 57.0 to 89.0	75 percentages of subjects Interval 58.0 to 88.0

SECONDARY outcome

Timeframe: 21 days after the second vaccination

Population: Analysis was done on per protocol (PP) dataset - subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.

Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=48 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=45 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=32 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=36 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age MenY (N=47,45)	100 percentages of subjects Interval 92.0 to 100.0	100 percentages of subjects Interval 92.0 to 100.0	66 percentages of subjects Interval 47.0 to 81.0	58 percentages of subjects Interval 41.0 to 74.0
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age MenA	90 percentages of subjects Interval 77.0 to 97.0	98 percentages of subjects Interval 88.0 to 100.0	97 percentages of subjects Interval 84.0 to 100.0	94 percentages of subjects Interval 81.0 to 99.0
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age MenC (N=47,45)	96 percentages of subjects Interval 85.0 to 99.0	100 percentages of subjects Interval 92.0 to 100.0	34 percentages of subjects Interval 19.0 to 53.0	47 percentages of subjects Interval 30.0 to 65.0
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age MenW (N=47,45)	100 percentages of subjects Interval 92.0 to 100.0	100 percentages of subjects Interval 92.0 to 100.0	78 percentages of subjects Interval 60.0 to 91.0	89 percentages of subjects Interval 74.0 to 97.0

SECONDARY outcome

Timeframe: 28 days after first vaccination.

Population: Analysis was done on per protocol (PP) dataset - subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.

Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=200 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=191 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA (Baseline)	0 percentages of subjects Interval 0.0 to 2.0	0 percentages of subjects Interval 0.0 to 2.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA (28 days after 1st vaccination)	82 percentages of subjects Interval 75.0 to 87.0	70 percentages of subjects Interval 63.0 to 77.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC (Baseline; N=198,190)	5 percentages of subjects Interval 2.0 to 9.0	1 percentages of subjects Interval 0.0 to 4.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC (28 days after 1st vaccination; N=198,190)	56 percentages of subjects Interval 49.0 to 63.0	49 percentages of subjects Interval 42.0 to 56.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW (Baseline)	8 percentages of subjects Interval 4.0 to 12.0	6 percentages of subjects Interval 3.0 to 10.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW (28 days after 1st vaccination)	82 percentages of subjects Interval 76.0 to 87.0	80 percentages of subjects Interval 73.0 to 85.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (Baseline; N=199,188)	5 percentages of subjects Interval 2.0 to 8.0	3 percentages of subjects Interval 1.0 to 7.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (28 days after 1st vaccination; N=199,188)	67 percentages of subjects Interval 60.0 to 74.0	67 percentages of subjects Interval 60.0 to 74.0	—	—

SECONDARY outcome

Timeframe: 28 days after first vaccination

Population: Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.

Immune response of one dose of MenACWY-CRM vaccine with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=200 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=191 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA (Baseline)	2 titers Interval 1.97 to 2.03	2 titers Interval 1.97 to 2.03	—	—
hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA (28 days after 1st vaccination)	18 titers Interval 15.0 to 23.0	13 titers Interval 11.0 to 16.0	—	—
hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC (Baseline; N=198,190)	2.16 titers Interval 2.03 to 2.3	2.05 titers Interval 1.92 to 2.18	—	—
hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC (28 days after 1st vaccination; N=198,190)	7.43 titers Interval 6.15 to 8.97	5.9 titers Interval 4.87 to 7.15	—	—
hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW (Baseline)	2.38 titers Interval 2.14 to 2.64	2.26 titers Interval 2.03 to 2.52	—	—
hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW (28 days after 1st vaccination)	17 titers Interval 14.0 to 21.0	16 titers Interval 13.0 to 20.0	—	—
hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (Baseline; N=199,188)	2.18 titers Interval 2.04 to 2.34	2.12 titers Interval 1.98 to 2.27	—	—
hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (28 days after 1st vaccination; N=199,188)	12 titers Interval 9.39 to 15.0	12 titers Interval 9.54 to 15.0	—	—

SECONDARY outcome

Timeframe: 28 days after first vaccination.

Population: Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.

Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with human complement serum bactericidal antibody (hSBA) titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=200 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=191 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA (Baseline)	0 percentages of subjects Interval 0.0 to 2.0	0 percentages of subjects Interval 0.0 to 2.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA (28 days after 1st vaccination)	72 percentages of subjects Interval 65.0 to 78.0	61 percentages of subjects Interval 53.0 to 68.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC (Baseline; N=198,190)	3 percentages of subjects Interval 1.0 to 6.0	1 percentages of subjects Interval 0.013 to 3.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC (28 days after 1st vaccination; N=198,190)	47 percentages of subjects Interval 40.0 to 54.0	36 percentages of subjects Interval 29.0 to 44.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW (Baseline)	6 percentages of subjects Interval 3.0 to 10.0	4 percentages of subjects Interval 1.0 to 7.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW (28 days after 1st vaccination)	72 percentages of subjects Interval 65.0 to 78.0	69 percentages of subjects Interval 62.0 to 76.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (Baseline; N=199,188)	4 percentages of subjects Interval 2.0 to 8.0	2 percentages of subjects Interval 1.0 to 5.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (28 days after 1st vaccination; N=199,188)	60 percentages of subjects Interval 53.0 to 67.0	57 percentages of subjects Interval 50.0 to 64.0	—	—

SECONDARY outcome

Timeframe: 21 days after second vaccination

Population: Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.

Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=61 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=48 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA (N=61,47)	98 percentages of subjects Interval 91.0 to 100.0	91 percentages of subjects Interval 80.0 to 98.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC	100 percentages of subjects Interval 94.0 to 100.0	94 percentages of subjects Interval 83.0 to 99.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW	97 percentages of subjects Interval 89.0 to 100.0	98 percentages of subjects Interval 89.0 to 100.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (N=61,47)	97 percentages of subjects Interval 89.0 to 100.0	91 percentages of subjects Interval 80.0 to 98.0	—	—

SECONDARY outcome

Timeframe: 21 days after second vaccination

Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.

Immune response to a second dose of either MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=61 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=48 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA (N=61,47)	98 percentages of subjects Interval 91.0 to 100.0	85 percentages of subjects Interval 72.0 to 94.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC	98 percentages of subjects Interval 91.0 to 100.0	90 percentages of subjects Interval 77.0 to 97.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW	97 percentages of subjects Interval 89.0 to 100.0	90 percentages of subjects Interval 77.0 to 97.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (N=61,47)	97 percentages of subjects Interval 89.0 to 100.0	83 percentages of subjects Interval 69.0 to 92.0	—	—

SECONDARY outcome

Timeframe: 21 days after second vaccination

Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.

Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=61 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=48 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA (N=61,47)	107 titers Interval 80.0 to 143.0	39 titers Interval 26.0 to 58.0	—	—
hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC	117 titers Interval 78.0 to 174.0	104 titers Interval 67.0 to 161.0	—	—
hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW	84 titers Interval 57.0 to 122.0	61 titers Interval 42.0 to 88.0	—	—
hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (N=61,47)	74 titers Interval 50.0 to 110.0	41 titers Interval 28.0 to 60.0	—	—

SECONDARY outcome

Timeframe: 6 months after first vaccination and 12 months after first vaccination

Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.

Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=57 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=56 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=56 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=54 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age MenA	3.54 titers Interval 2.67 to 4.69	2.54 titers Interval 1.91 to 3.37	2.66 titers Interval 2.07 to 3.42	2.41 titers Interval 1.87 to 3.12
hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age MenC	10 titers Interval 7.21 to 15.0	4.02 titers Interval 2.78 to 5.82	9.07 titers Interval 6.35 to 13.0	4.79 titers Interval 3.33 to 6.88
hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age MenW (N=57,54,56,54)	21 titers Interval 14.0 to 31.0	19 titers Interval 12.0 to 28.0	14 titers Interval 9.6 to 21.0	8.19 titers Interval 5.5 to 12.0
hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age MenY (N=57,55,55,52)	12 titers Interval 8.1 to 17.0	8.69 titers Interval 5.88 to 13.0	10 titers Interval 6.62 to 16.0	10 titers Interval 6.39 to 16.0

SECONDARY outcome

Timeframe: 6 months after first vaccination and 12 months after first vaccination

Population: Analysis was done on PP dataset -subset of subjects in the MITT population for the evaluation of immunogenicity after the 1st dose of either MenACWY Ad+ / Ad- conjugate vaccine who received a booster dose of either Novartis MenACWY Ad+/ Ad- conjugate vaccine, provided evaluable serum samples at day 169 and 358, had no major protocol deviation.

Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=57 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=56 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=56 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=54 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA	26 percentages of subjects Interval 16.0 to 40.0	14 percentages of subjects Interval 6.0 to 26.0	18 percentages of subjects Interval 9.0 to 30.0	9 percentages of subjects Interval 3.0 to 20.0
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC	56 percentages of subjects Interval 42.0 to 69.0	34 percentages of subjects Interval 22.0 to 48.0	63 percentages of subjects Interval 49.0 to 75.0	33 percentages of subjects Interval 21.0 to 47.0
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW	82 percentages of subjects Interval 70.0 to 91.0	79 percentages of subjects Interval 66.0 to 88.0	77 percentages of subjects Interval 64.0 to 87.0	54 percentages of subjects Interval 40.0 to 67.0
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (N=57,56,55,52)	65 percentages of subjects Interval 51.0 to 77.0	66 percentages of subjects Interval 52.0 to 78.0	67 percentages of subjects Interval 53.0 to 79.0	56 percentages of subjects Interval 41.0 to 70.0

SECONDARY outcome

Timeframe: 6 months after first vaccination and 12 months after first vaccination

Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.

Persistence of immune response at 6 or 12 months after one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=57 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=56 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=56 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=54 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age MenA	21 percentages of subjects Interval 11.0 to 34.0	13 percentages of subjects Interval 5.0 to 24.0	11 percentages of subjects Interval 4.0 to 22.0	7 percentages of subjects Interval 2.0 to 18.0
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age MenC	51 percentages of subjects Interval 37.0 to 64.0	25 percentages of subjects Interval 14.0 to 38.0	57 percentages of subjects Interval 43.0 to 70.0	26 percentages of subjects Interval 15.0 to 40.0
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age MenW	72 percentages of subjects Interval 58.0 to 83.0	73 percentages of subjects Interval 60.0 to 84.0	70 percentages of subjects Interval 56.0 to 81.0	50 percentages of subjects Interval 36.0 to 64.0
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (N=57,56,55,52)	58 percentages of subjects Interval 44.0 to 71.0	50 percentages of subjects Interval 36.0 to 64.0	55 percentages of subjects Interval 41.0 to 68.0	46 percentages of subjects Interval 32.0 to 61.0

SECONDARY outcome

Timeframe: 21 days after the second vaccination

Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=57 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=56 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=57 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=56 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA (N=54,56,57,56)	168 titers Interval 116.0 to 242.0	328 titers Interval 242.0 to 445.0	141 titers Interval 104.0 to 191.0	66 titers Interval 46.0 to 94.0
hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC (N=54,56,56,57)	575 titers Interval 381.0 to 866.0	586 titers Interval 386.0 to 889.0	252 titers Interval 168.0 to 377.0	297 titers Interval 197.0 to 449.0
hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW (N=57,55,57,56)	1238 titers Interval 878.0 to 1745.0	1263 titers Interval 849.0 to 1879.0	687 titers Interval 465.0 to 1015.0	518 titers Interval 370.0 to 726.0
hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (N=52,56,57,55)	915 titers Interval 633.0 to 1322.0	983 titers Interval 651.0 to 1483.0	489 titers Interval 325.0 to 735.0	302 titers Interval 211.0 to 432.0

SECONDARY outcome

Timeframe: 21 days after second vaccination

Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.

Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=56 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=54 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=57 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=56 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA	100 percentages of subjects Interval 94.0 to 100.0	96 percentages of subjects Interval 87.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0	95 percentages of subjects Interval 85.0 to 99.0
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC	98 percentages of subjects Interval 90.0 to 100.0	96 percentages of subjects Interval 87.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW	98 percentages of subjects Interval 90.0 to 100.0	100 percentages of subjects Interval 93.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (N=56,52,57,55)	100 percentages of subjects Interval 94.0 to 100.0	100 percentages of subjects Interval 93.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0

SECONDARY outcome

Timeframe: 21 days after second vaccination

Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.

Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered either at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=56 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=54 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=57 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=56 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age MenA	100 percentages of subjects Interval 94.0 to 100.0	96 percentages of subjects Interval 87.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0	91 percentages of subjects Interval 80.0 to 97.0
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age MenC	98 percentages of subjects Interval 90.0 to 100.0	96 percentages of subjects Interval 87.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age MenW	98 percentages of subjects Interval 90.0 to 100.0	100 percentages of subjects Interval 93.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age MenY (N=56,52,57,55)	100 percentages of subjects Interval 94.0 to 100.0	100 percentages of subjects Interval 93.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0	100 percentages of subjects Interval 94.0 to 100.0

SECONDARY outcome

Timeframe: 12 months after second vaccination

Population: Analysis was done on PP dataset Immunogenicity of a booster dose - subset of subjects in the MITT population who received a booster dose of either MenACWY Ad+/Ad- conjugate vaccine, and provided evaluable serum samples at day 169, 358 \& had no major protocol deviation.

Persistence of immune response at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=61 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=49 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age MenA (N=61,48)	5.24 titers Interval 3.98 to 6.89	4.15 titers Interval 3.16 to 5.45	—	—
hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age MenC	13 titers Interval 8.86 to 18.0	18 titers Interval 12.0 to 28.0	—	—
hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age MenW (N=61,47)	29 titers Interval 20.0 to 42.0	25 titers Interval 17.0 to 37.0	—	—
hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age MenY (N=61,48)	19 titers Interval 13.0 to 27.0	19 titers Interval 12.0 to 31.0	—	—

SECONDARY outcome

Timeframe: 12 months after second vaccination

Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.

Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=61 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=49 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenA (N=61,48)	43 percentages of subjects Interval 30.0 to 56.0	29 percentages of subjects Interval 17.0 to 44.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenC	66 percentages of subjects Interval 52.0 to 77.0	73 percentages of subjects Interval 59.0 to 85.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenW (N=61,47)	89 percentages of subjects Interval 78.0 to 95.0	87 percentages of subjects Interval 74.0 to 95.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age MenY	80 percentages of subjects Interval 68.0 to 89.0	81 percentages of subjects Interval 67.0 to 91.0	—	—

SECONDARY outcome

Timeframe: 12 months after second vaccination

Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.

Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=61 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=49 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age MenA (N=61,48)	38 percentages of subjects Interval 26.0 to 51.0	23 percentages of subjects Interval 12.0 to 37.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age MenC	59 percentages of subjects Interval 46.0 to 71.0	63 percentages of subjects Interval 48.0 to 77.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age MenW (N=61,47)	87 percentages of subjects Interval 76.0 to 94.0	85 percentages of subjects Interval 72.0 to 94.0	—	—
Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age MenY (N=61,48)	69 percentages of subjects Interval 56.0 to 80.0	71 percentages of subjects Interval 56.0 to 83.0	—	—

SECONDARY outcome

Timeframe: From day 1 through day 7 after first or second vaccination(s)

Population: Analysis was done on Safety dataset - all subjects who received at least one dose of vaccine and with some post-baseline safety data.

Safety was assessed as the number of subjects 12 to 59 months of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the first or second vaccination(s) with MenACWY-CRM vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=205 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=206 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=125 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=81 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Other	44 Subjects	38 Subjects	22 Subjects	11 Subjects
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Any Local	100 Subjects	109 Subjects	70 Subjects	48 Subjects
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Injection site tenderness	73 Subjects	79 Subjects	57 Subjects	42 Subjects
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Injection site erythema	60 Subjects	63 Subjects	37 Subjects	19 Subjects
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Injetion site induration	37 Subjects	38 Subjects	25 Subjects	15 Subjects
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Any systemic	98 Subjects	103 Subjects	53 Subjects	26 Subjects
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Change in Eating Habits	31 Subjects	46 Subjects	20 Subjects	10 Subjects
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Irritability	68 Subjects	74 Subjects	31 Subjects	12 Subjects
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Vomiting	17 Subjects	15 Subjects	9 Subjects	2 Subjects
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Diarrhea	22 Subjects	24 Subjects	12 Subjects	1 Subjects
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Fever (≥ 38°C)	18 Subjects	23 Subjects	10 Subjects	5 Subjects
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Analgesic/Antipyretic Med Used	39 Subjects	35 Subjects	20 Subjects	11 Subjects

SECONDARY outcome

Timeframe: 28 days after first vaccination and 21 days after second vaccination

Population: Analysis was done on Safety dataset - all subjects who received at least one dose of vaccine and with some post-baseline safety data.

Safety was assessed as the number of subjects 12 to 59 months of age who reported serious adverse events (SAE), AEs necessitating a physician's visit and/or resulting in premature withdrawal from the study, AEs were to be collected between day 7 and the subsequent visit (approximately 1 month later) after the first or second vaccination(s) of MenACWY-CRM vaccine, with or without adjuvant, or MenACWY-PS vaccine. Any SAE were to be collected throughout the study.

Outcome measures

Outcome measures
Measure	MenACWY-CRM(Ad-) (36 to 59 Months) n=205 Participants Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.	MenACWY-PS (36 to 59 Months) n=206 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.	MenACWY-PS (36-59 M6PS) n=125 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).	MenACWY-PS (36-59 M12PS) n=81 Participants Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination Any AE	117 Subjects	99 Subjects	64 Subjects	41 Subjects
Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination Possibly/probably related AE	9 Subjects	9 Subjects	3 Subjects	1 Subjects
Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination SAE	13 Subjects	12 Subjects	11 Subjects	9 Subjects
Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination AE leading to discontinuation	3 Subjects	1 Subjects	0 Subjects	0 Subjects
Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination Possibly/probably related SAE	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination Death	0 Subjects	0 Subjects	0 Subjects	0 Subjects

Adverse Events

MenACWY-CRM(Ad+) 12 to 35 Months

Serious events: 13 serious events

Other events: 155 other events

Deaths: 0 deaths

MenACWY-CRM(Ad-) 12 to 35 Months

Serious events: 12 serious events

Other events: 158 other events

Deaths: 0 deaths

MenACWY-CRM(Ad-) 36 to 59 Months

Serious events: 11 serious events

Other events: 97 other events

Deaths: 0 deaths

MenACWY-PS (36 to 59 Months)

Serious events: 9 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60