Trial Outcomes & Findings for Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers (NCT NCT01994629)

NCT ID: NCT01994629

Last Updated: 2015-11-04

Results Overview

Reactogenicity of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by number of subjects with at least one severe solicited AE within 7 days after vaccination. Solicited AEs included tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

202 participants

Primary outcome timeframe

Day 1 to Day 7 post-vaccination

Results posted on

2015-11-04

Participant Flow

Subjects were enrolled from 4 centers in Italy.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	MenACWY-CRM (12 to 15 Months Old) Subjects received one dose of investigational MenACWY-cross reactive material (CRM) vaccine.	MenACWY-TT (12 to 15 Months Old) Subjects received one dose of comparator MenACWY-tetanus toxoid (TT) vaccine.
Overall Study STARTED	100	102
Overall Study COMPLETED	99	99
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	MenACWY-CRM (12 to 15 Months Old) Subjects received one dose of investigational MenACWY-cross reactive material (CRM) vaccine.	MenACWY-TT (12 to 15 Months Old) Subjects received one dose of comparator MenACWY-tetanus toxoid (TT) vaccine.
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenACWY-CRM (12 to 15 Months Old) n=100 Participants Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=102 Participants Subjects received one dose of comparator MenACWY-TT vaccine.	Total n=202 Participants Total of all reporting groups
Age, Continuous	12.8 Months STANDARD_DEVIATION 1 • n=5 Participants	12.7 Months STANDARD_DEVIATION 0.9 • n=7 Participants	12.7 Months STANDARD_DEVIATION 0.9 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	46 Participants n=7 Participants	94 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	56 Participants n=7 Participants	108 Participants n=5 Participants
Region of Enrollment Italy	100 Subjects n=5 Participants	102 Subjects n=7 Participants	202 Subjects n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 7 post-vaccination

Population: Analysis was done on the solicited safety data set (all subjects in the exposed set who provided post vaccination reactogenicity data: MenACWY-CRM 99; MenACWY-TT 101).

Outcome measures

Outcome measures
Measure	MenACWY-CRM (12 to 15 Months Old) n=99 Participants Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=101 Participants Subjects received one dose of comparator MenACWY-TT vaccine.
Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT.	4 Number of Subjects	2 Number of Subjects

SECONDARY outcome

Timeframe: Day 1, Day 29 and Day 180 post-vaccination

Population: Analysis was done on Full Analysis Set (FAS) Day 29 (subjects who received the vaccine and provided immunogenicity data at Day 29: MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS Day 180 (subjects who received the vaccine and provided immunogenicity data at Day 180: MenACWY-CRM 98; MenACWT-TT 97).

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with hSBA titer ≥ 8 directed against Neisseria meningitidis (N. meningitidis) serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by the percentages of subjects with hSBA titer ≥ 8 on Day 180 post-vaccination.

Outcome measures

Outcome measures
Measure	MenACWY-CRM (12 to 15 Months Old) n=98 Participants Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=97 Participants Subjects received one dose of comparator MenACWY-TT vaccine.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 1 (N=89,92)	2 percentage of Subjects Interval 0.27 to 7.9	0 percentage of Subjects Interval 0.0 to 3.9
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 29 (N=91,97)	90 percentage of Subjects Interval 82.1 to 95.4	88 percentage of Subjects Interval 79.4 to 93.4
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 180 (N=97,96)	65 percentage of Subjects Interval 54.6 to 74.4	30 percentage of Subjects Interval 21.3 to 40.4
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 1 (N=92,93)	3 percentage of Subjects Interval 0.7 to 9.2	1 percentage of Subjects Interval 0.03 to 5.8
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 29 (N=94,97)	96 percentage of Subjects Interval 89.5 to 98.8	86 percentage of Subjects Interval 77.0 to 91.9
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 180 (N=96,95)	88 percentage of Subjects Interval 79.2 to 93.4	95 percentage of Subjects Interval 88.1 to 98.3
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 1 (N=81,78)	6 percentage of Subjects Interval 2.0 to 13.8	4 percentage of Subjects Interval 0.8 to 10.8
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 29 (N=84,87)	62 percentage of Subjects Interval 50.7 to 72.3	72 percentage of Subjects Interval 61.8 to 81.5
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 180 (N=88,89)	88 percentage of Subjects Interval 78.7 to 93.6	100 percentage of Subjects Interval 95.9 to 100.0
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 1 (N=84,84)	4 percentage of Subjects Interval 0.7 to 10.1	2 percentage of Subjects Interval 0.29 to 8.3
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 29 (N=87,91)	41 percentage of Subjects Interval 30.9 to 52.4	56 percentage of Subjects Interval 45.2 to 66.4
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 180 (N=92,95)	78 percentage of Subjects Interval 68.4 to 86.2	98 percentage of Subjects Interval 92.6 to 99.74

SECONDARY outcome

Timeframe: Day 29 and Day 180 post-vaccination

Population: Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with seroresponse defined as for subjects with pre-vaccination hSBA titer \< 4, post-vaccination hSBA titer ≥ 8; for subjects with pre-vaccination hSBA titer ≥ 4, an increase of at least four times the pre-vaccination hSBA directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence immune response was measured by the percentage of subjects with seroresponse at Day 180 after vaccination.

Outcome measures

Outcome measures
Measure	MenACWY-CRM (12 to 15 Months Old) n=98 Participants Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=97 Participants Subjects received one dose of comparator MenACWY-TT vaccine.
Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 29 (N=89,92)	88 percentage of Subjects Interval 79.0 to 93.7	87 percentage of Subjects Interval 78.3 to 93.1
Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 180 (N=95,92)	62 percentage of Subjects Interval 51.6 to 71.9	29 percentage of Subjects Interval 20.3 to 39.8
Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 29 (N=92,93)	95 percentage of Subjects Interval 87.8 to 98.2	84 percentage of Subjects Interval 74.8 to 90.7
Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 180 (N=94,92)	85 percentage of Subjects Interval 76.3 to 91.6	93 percentage of Subjects Interval 86.3 to 97.6
Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 29 (N=81,78)	54 percentage of Subjects Interval 42.9 to 65.4	73 percentage of Subjects Interval 61.8 to 82.5
Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 180 (N=83,81)	83 percentage of Subjects Interval 73.3 to 90.5	99 percentage of Subjects Interval 93.3 to 99.97
Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 29 (N=84,84)	39 percentage of Subjects Interval 28.8 to 50.5	54 percentage of Subjects Interval 42.4 to 64.5
Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 180 (N=88,87)	74 percentage of Subjects Interval 63.4 to 82.7	95 percentage of Subjects Interval 88.6 to 98.7

SECONDARY outcome

Timeframe: Day 1, Day 29 and Day 180 post-vaccination

Population: Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by hSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by hSBA GMTs at Day 180 after vaccination.

Outcome measures

Outcome measures
Measure	MenACWY-CRM (12 to 15 Months Old) n=98 Participants Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=97 Participants Subjects received one dose of comparator MenACWY-TT vaccine.
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 180 (N=92,95)	16 Titers Interval 12.0 to 21.0	26 Titers Interval 20.0 to 34.0
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 1 (N=89,92)	2.19 Titers Interval 2.02 to 2.38	2.04 Titers Interval 1.89 to 2.21
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 29 (N=91,97)	41 Titers Interval 31.0 to 55.0	30 Titers Interval 23.0 to 40.0
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 180 (N=97,96)	13 Titers Interval 9.5 to 18.0	4.67 Titers Interval 3.43 to 6.36
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 1 (N=92,93)	2.44 Titers Interval 2.16 to 2.76	2.24 Titers Interval 1.99 to 2.52
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 29 (N=94,97)	30 Titers Interval 23.0 to 39.0	20 Titers Interval 16.0 to 26.0
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 180 (N=96,95)	24 Titers Interval 18.0 to 30.0	41 Titers Interval 32.0 to 53.0
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 1 (N=81,78)	2.58 Titers Interval 2.12 to 3.15	2.4 Titers Interval 1.96 to 2.95
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 29 (N=84,87)	9.34 Titers Interval 6.72 to 13.0	14 Titers Interval 9.91 to 19.0
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 180 (N=88,89)	21 Titers Interval 17.0 to 27.0	56 Titers Interval 45.0 to 70.0
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 1 (N=84,84)	2.23 Titers Interval 2.02 to 2.48	2.16 Titers Interval 1.94 to 2.4
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 29 (N=87,91)	5.89 Titers Interval 4.27 to 8.13	8.20 Titers Interval 5.96 to 11.0

SECONDARY outcome

Timeframe: Day 1, Day 29 and Day 180 post-vaccination

Population: Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 8 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 8 on Day 180 after vaccination.

Outcome measures

Outcome measures
Measure	MenACWY-CRM (12 to 15 Months Old) n=98 Participants Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=97 Participants Subjects received one dose of comparator MenACWY-TT vaccine.
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 1 (rabbit; N=63,61)	24 percentage of Subjects Interval 14.0 to 36.2	31 percentage of Subjects Interval 19.9 to 44.3
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 29 (rabbit; N=73,74)	100 percentage of Subjects Interval 95.1 to 100.0	100 percentage of Subjects Interval 95.1 to 100.0
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 180 (rabbit; N=74,75)	100 percentage of Subjects Interval 95.1 to 100.0	93 percentage of Subjects Interval 85.1 to 97.8
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 1 (rabbit; N=64,62)	3 percentage of Subjects Interval 0.38 to 10.8	0 percentage of Subjects Interval 0.0 to 5.8
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 29 (rabbit; N=74,74)	92 percentage of Subjects Interval 83.2 to 97.0	97 percentage of Subjects Interval 90.6 to 99.67
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 180 (rabbit; N=77,76)	64 percentage of Subjects Interval 51.9 to 74.3	71 percentage of Subjects Interval 59.5 to 80.9
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 1 (rabbit; N=61,57)	7 percentage of Subjects Interval 1.8 to 15.9	5 percentage of Subjects Interval 1.1 to 14.6
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 29 (rabbit; N=70,69)	90 percentage of Subjects Interval 80.5 to 95.9	91 percentage of Subjects Interval 82.0 to 96.7
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 180 (rabbit; N=73,70)	71 percentage of Subjects Interval 59.4 to 81.2	87 percentage of Subjects Interval 77.0 to 93.9
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 1 (rabbit; N=61,59)	10 percentage of Subjects Interval 3.7 to 20.2	15 percentage of Subjects Interval 7.2 to 27.0
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 29 (rabbit; N=70,70)	90 percentage of Subjects Interval 80.5 to 95.9	89 percentage of Subjects Interval 78.7 to 94.9
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 180 (rabbit; N=74,71)	80 percentage of Subjects Interval 68.8 to 88.2	82 percentage of Subjects Interval 70.7 to 89.9

SECONDARY outcome

Timeframe: Day 1, Day 29 and Day 180 post-vaccination

Population: Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 128 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 128 on Day 180 after vaccination.

Outcome measures

Outcome measures
Measure	MenACWY-CRM (12 to 15 Months Old) n=98 Participants Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=97 Participants Subjects received one dose of comparator MenACWY-TT vaccine.
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 1 (rabbit; N=64,62)	3 percentage of Subjects Interval 0.38 to 10.8	0 percentage of Subjects Interval 0.0 to 5.8
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 1 (rabbit; N=63,61)	22 percentage of Subjects Interval 12.7 to 34.5	31 percentage of Subjects Interval 19.9 to 44.3
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 29 (rabbit; N=73,74)	100 percentage of Subjects Interval 95.1 to 100.0	100 percentage of Subjects Interval 95.1 to 100.0
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 180 (rabbit; N=74,75)	100 percentage of Subjects Interval 95.1 to 100.0	91 percentage of Subjects Interval 81.7 to 96.2
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 29 (rabbit; N=74,74)	78 percentage of Subjects Interval 67.3 to 87.1	65 percentage of Subjects Interval 52.9 to 75.6
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 180 (rabbit; N=77,76)	25 percentage of Subjects Interval 15.6 to 35.8	33 percentage of Subjects Interval 22.5 to 44.6
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 1 (rabbit; N=61,57)	7 percentage of Subjects Interval 1.8 to 15.9	5 percentage of Subjects Interval 1.1 to 14.6
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 29 (rabbit; N=70,69)	90 percentage of Subjects Interval 80.5 to 95.9	90 percentage of Subjects Interval 80.2 to 95.8
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 180 (rabbit; N=73,70)	62 percentage of Subjects Interval 49.5 to 72.8	66 percentage of Subjects Interval 53.4 to 76.7
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 1 (rabbit; N=61,59)	10 percentage of Subjects Interval 3.7 to 20.2	12 percentage of Subjects Interval 4.9 to 22.9
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 29 (rabbit; N=70,70)	89 percentage of Subjects Interval 78.7 to 94.9	86 percentage of Subjects Interval 75.3 to 92.9
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 180 (rabbit; N=74,71)	73 percentage of Subjects Interval 61.4 to 82.6	62 percentage of Subjects Interval 49.7 to 73.2

SECONDARY outcome

Timeframe: Day 29 and Day 180 post-vaccination

Population: Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with four-fold increase in rSBA titer directed against N. meningitides serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by the percentages of subjects with four-fold increase in rSBA titer on Day 180 after vaccination.

Outcome measures

Outcome measures
Measure	MenACWY-CRM (12 to 15 Months Old) n=98 Participants Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=97 Participants Subjects received one dose of comparator MenACWY-TT vaccine.
Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 29 (rabbit; N=63,61)	100 percentage of Subjects Interval 94.3 to 100.0	93 percentage of Subjects Interval 84.1 to 98.2
Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 180 (rabbit; N=60,61)	97 percentage of Subjects Interval 88.5 to 99.59	84 percentage of Subjects Interval 71.9 to 91.8
Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 29 (rabbit; N=64,62)	75 percentage of Subjects Interval 62.6 to 85.0	65 percentage of Subjects Interval 51.3 to 76.3
Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 180 (rabbit; N=64,63)	20 percentage of Subjects Interval 11.3 to 32.2	30 percentage of Subjects Interval 19.2 to 43.0
Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 29 (rabbit; N=61,57)	87 percentage of Subjects Interval 75.8 to 94.2	89 percentage of Subjects Interval 78.5 to 96.0
Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 180 (rabbit; N=58,58)	55 percentage of Subjects Interval 41.5 to 68.3	66 percentage of Subjects Interval 51.9 to 77.5
Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 29 (rabbit; N=61,59)	87 percentage of Subjects Interval 75.8 to 94.2	88 percentage of Subjects Interval 77.1 to 95.1
Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 180 (rabbit; N=61,59)	72 percentage of Subjects Interval 59.2 to 82.9	56 percentage of Subjects Interval 42.4 to 68.8

SECONDARY outcome

Timeframe: Day 1, Day 29 and Day 180 post-vaccination

Population: Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by rSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by rSBA GMTs on Day 180.

Outcome measures

Outcome measures
Measure	MenACWY-CRM (12 to 15 Months Old) n=98 Participants Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=97 Participants Subjects received one dose of comparator MenACWY-TT vaccine.
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 29 (rabbit; N=73,74)	5698 Titers Interval 4226.0 to 7684.0	2827 Titers Interval 2116.0 to 3775.0
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 1 (rabbit; N=63,61)	6.62 Titers Interval 3.12 to 14.0	12 Titers Interval 5.59 to 26.0
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. A Day 180 (rabbit; N=74,75)	2815 Titers Interval 1741.0 to 4550.0	950 Titers Interval 592.0 to 1523.0
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 1 (rabbit; N=64,62)	2.46 Titers Interval 1.98 to 3.05	2.07 Titers Interval 1.66 to 2.58
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 29 (rabbit; N=74,74)	171 Titers Interval 113.0 to 259.0	142 Titers Interval 95.0 to 213.0
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. C Day 180 (rabbit; N=77,76)	20 Titers Interval 12.0 to 33.0	22 Titers Interval 13.0 to 36.0
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 1 (rabbit; N=61,57)	3.1 Titers Interval 2.09 to 4.59	3.17 Titers Interval 2.07 to 4.86
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 29 (rabbit; N=70,69)	1092 Titers Interval 570.0 to 2089.0	1060 Titers Interval 553.0 to 2031.0
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. W Day 180 (rabbit; N=73,70)	91 Titers Interval 46.0 to 182.0	142 Titers Interval 72.0 to 282.0
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 1 (rabbit; N=61,59)	3.46 Titers Interval 2.03 to 5.89	4.22 Titers Interval 2.42 to 7.38
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 29 (rabbit; N=70,70)	756 Titers Interval 400.0 to 1429.0	624 Titers Interval 333.0 to 1168.0
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Y Day 180 (rabbit; N=74,71)	248 Titers Interval 124.0 to 495.0	140 Titers Interval 70.0 to 278.0

SECONDARY outcome

Timeframe: Day 1 (6 hours) to Day 7 post-vaccination

Population: Analysis was done on solicited safety data set. MedDRA version v.3.0 was used for the analyses (in the AEs section, MedDRA version v.17.01 was used, leading to a different terminology to describe some of the events reported in this outcome).

Safety was assessed in terms of number of subjects (12 to 15 months old) reporting any and each of solicited local and systemic AEs reported from Day 1 to 7 after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.

Outcome measures

Outcome measures
Measure	MenACWY-CRM (12 to 15 Months Old) n=99 Participants Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=101 Participants Subjects received one dose of comparator MenACWY-TT vaccine.
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Any Local	34 Subjects	29 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Tenderness (N=97,100)	29 Subjects	26 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Erythema (N=97,100)	4 Subjects	2 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Induration (N=97,101)	6 Subjects	4 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Any Systemic	56 Subjects	57 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Irritability (N=96,99)	30 Subjects	39 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Sleepiness (N=96,98)	23 Subjects	26 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Change in eating habits (N=96,100)	22 Subjects	26 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Vomiting (N=96,99)	6 Subjects	9 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Diarrhea (N=96,99)	17 Subjects	18 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Fever (≥ 38.0°C; N=99,100))	14 Subjects	13 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Prophylatic use of analg./antipyr. (N=97,100)	1 Subjects	4 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Therapeutic use of analg./antipyr. (N=98,100)	13 Subjects	13 Subjects

SECONDARY outcome

Timeframe: Day 1 to Day 29 or Day 1 to Day 180 post-vaccination

Population: Analysis was done on unsolicited safety data set ie, all subjects in the exposed set who had post-vaccination unsolicited adverse event records.

Safety was assessed in terms of number of subjects (12 to 15 months old) reporting unsolicited AEs (day 1 to day 29), SAEs, medically attended AEs, AEs leading to premature study withdrawal (Day 1 to Day 180) after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.

Outcome measures

Outcome measures
Measure	MenACWY-CRM (12 to 15 Months Old) n=99 Participants Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=101 Participants Subjects received one dose of comparator MenACWY-TT vaccine.
Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Any unsolicited AEs	73 Subjects	71 Subjects
Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. AEs leading to premature withdrawal	0 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. SAEs	8 Subjects	3 Subjects
Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Medically attended AEs	73 Subjects	68 Subjects
Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. Death	0 Subjects	0 Subjects

Adverse Events

MenACWY-CRM (12 to 15 Months Old)

Serious events: 8 serious events

Other events: 83 other events

Deaths: 0 deaths

MenACWY-TT (12 to 15 Months Old)

Serious events: 3 serious events

Other events: 87 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MenACWY-CRM (12 to 15 Months Old) n=99 participants at risk Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=101 participants at risk Subjects received one dose of comparator MenACWY-TT vaccine.
Injury, poisoning and procedural complications Head injury	1.0% 1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	0.00% 0/101 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/99 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	0.99% 1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Injury, poisoning and procedural complications Tongue injury	1.0% 1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	0.00% 0/101 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Nervous system disorders Febrile convulsion	1.0% 1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	0.99% 1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Skin and subcutaneous tissue disorders Urticaria	1.0% 1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	0.00% 0/101 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Infections and infestations Bacteremia	1.0% 1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	0.00% 0/101 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/99 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	0.99% 1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Infections and infestations Cellulitis	1.0% 1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	0.00% 0/101 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Infections and infestations Rotavirus infection	2.0% 2/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	0.00% 0/101 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.

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: OTHER

Measure	MenACWY-CRM (12 to 15 Months Old) n=99 participants at risk Subjects received one dose of investigational MenACWY-CRM vaccine.	MenACWY-TT (12 to 15 Months Old) n=101 participants at risk Subjects received one dose of comparator MenACWY-TT vaccine.
Respiratory, thoracic and mediastinal disorders Bronchospasm	1.0% 1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	7.9% 8/101 • Number of events 12 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	9.1% 9/99 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	4.0% 4/101 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 9/99 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	7.9% 8/101 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Nervous system disorders Somnolence	23.2% 23/99 • Number of events 26 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	26.7% 27/101 • Number of events 30 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
General disorders Injection site induration	25.3% 25/99 • Number of events 26 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	25.7% 26/101 • Number of events 26 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
General disorders Injection site pain	29.3% 29/99 • Number of events 30 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	26.7% 27/101 • Number of events 27 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
General disorders Pyrexia	31.3% 31/99 • Number of events 44 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	33.7% 34/101 • Number of events 48 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
General disorders Injection site erythema	26.3% 26/99 • Number of events 26 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	26.7% 27/101 • Number of events 27 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Psychiatric disorders Eating disorder	22.2% 22/99 • Number of events 27 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	25.7% 26/101 • Number of events 28 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Psychiatric disorders Irritability	30.3% 30/99 • Number of events 37 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	39.6% 40/101 • Number of events 46 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Gastrointestinal disorders Vomiting	8.1% 8/99 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	10.9% 11/101 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Gastrointestinal disorders Diarrhea	21.2% 21/99 • Number of events 26 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	21.8% 22/101 • Number of events 29 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Skin and subcutaneous tissue disorders Rash	5.1% 5/99 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	0.99% 1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Infections and infestations Conjunctivitis	6.1% 6/99 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	7.9% 8/101 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Infections and infestations Ear infection	15.2% 15/99 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	4.0% 4/101 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Infections and infestations Rhinitis	5.1% 5/99 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	2.0% 2/101 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Infections and infestations Exhantema subitum	7.1% 7/99 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	5.0% 5/101 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Infections and infestations Gastroenteritis	2.0% 2/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.	5.9% 6/101 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.