Trial Outcomes & Findings for Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life (NCT NCT01214837)

NCT ID: NCT01214837

Last Updated: 2018-10-09

Results Overview

The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 751 participants
• Primary outcome timeframe: 13 months of age
• Results posted on: 2018-10-09

Participant Flow

Subjects were enrolled at 3 sites in Canada and 37 sites in United States of America.

All the enrolled subjects were included in the trial.

Participant milestones

Measure	MenACWY3 Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.	MenACWY4 All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines Subjects received routine vaccines only, including pneumococcal 13-valent conjugate vaccine (PCV-13), at 2, 4, 6 and 12 months of age.
Overall Study STARTED	249	256	246
Overall Study COMPLETED	195	192	184
Overall Study NOT COMPLETED	54	64	62

Reasons for withdrawal

Measure	MenACWY3 Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.	MenACWY4 All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines Subjects received routine vaccines only, including pneumococcal 13-valent conjugate vaccine (PCV-13), at 2, 4, 6 and 12 months of age.
Overall Study Death	0	0	1
Overall Study Adverse Event	1	2	1
Overall Study Withdrawal by Subject	27	36	28
Overall Study Lost to Follow-up	20	15	21
Overall Study Inappropriate Enrolment	0	1	2
Overall Study Administrative Reason	2	6	4
Overall Study Protocol Violation	3	1	5
Overall Study Unable to Classify	1	3	0

Baseline Characteristics

Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life

Baseline characteristics by cohort

Measure	MenACWY3 n=249 Participants Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.	MenACWY4 n=256 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines n=246 Participants Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.	Total n=751 Participants Total of all reporting groups
Age, Continuous	66.4 Days STANDARD_DEVIATION 7.1 • n=5 Participants	66.7 Days STANDARD_DEVIATION 7.4 • n=7 Participants	66.7 Days STANDARD_DEVIATION 7.0 • n=5 Participants	66.6 Days STANDARD_DEVIATION 7.2 • n=4 Participants
Sex: Female, Male Female	126 Participants n=5 Participants	123 Participants n=7 Participants	106 Participants n=5 Participants	355 Participants n=4 Participants
Sex: Female, Male Male	123 Participants n=5 Participants	133 Participants n=7 Participants	140 Participants n=5 Participants	396 Participants n=4 Participants

PRIMARY outcome

Timeframe: 13 months of age

Population: Analysis was done on the Toddler Per Protocol Population (PPS) - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding through 13 month timepoint.

The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.

Outcome measures

Measure	MenACWY4 n=152 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. Serogroup A (N=141)	96 Percentage of subjects Interval 91.0 to 98.0	—	—
Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. Serogroup C	99 Percentage of subjects Interval 95.0 to 100.0	—	—
Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. Serogroup W (N=138)	99 Percentage of subjects Interval 96.0 to 100.0	—	—
Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. Serogroup Y (N=146)	99 Percentage of subjects Interval 96.0 to 100.0	—	—

PRIMARY outcome

Timeframe: 13 months of age

Population: Analysis was done on Toddler PPS.

The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.

Outcome measures

Measure	MenACWY4 n=160 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 n=152 Participants Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. Serogroup Y (N=154,146)	100 Percentage of subjects Interval 98.0 to 100.0	99 Percentage of subjects Interval 96.0 to 100.0	—
Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. Serogroup A (N=146,141)	88 Percentage of subjects Interval 82.0 to 93.0	96 Percentage of subjects Interval 91.0 to 98.0	—
Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. Serogroup C	95 Percentage of subjects Interval 90.0 to 98.0	99 Percentage of subjects Interval 95.0 to 100.0	—
Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. Serogroup W (N=153,138)	99 Percentage of subjects Interval 96.0 to 100.0	99 Percentage of subjects Interval 96.0 to 100.0	—

SECONDARY outcome

Timeframe: Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age

Population: Analysis was done on Infant PPS - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding, through the 7 month timepoint.

Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age.

Outcome measures

Measure	MenACWY4 n=185 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 n=176 Participants Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines n=187 Participants Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup W (4 months; N=0,71,0)	NA Percentages of subjects Data was not collected at this timepoint	35 Percentages of subjects Interval 24.0 to 47.0	NA Percentages of subjects Data was not collected at this timepoint
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup A (baseline; N=0,0,166)	NA Percentages of subjects Data was not collected at this timepoint	NA Percentages of subjects Data was not collected at this timepoint	4 Percentages of subjects Interval 1.0 to 8.0
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup A (3 months; N=0,82,0)	NA Percentages of subjects Data was not collected at this timepoint	9 Percentages of subjects Interval 4.0 to 17.0	NA Percentages of subjects Data was not collected at this timepoint
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup W (baseline; N=0,0,157)	NA Percentages of subjects Data was not collected at this timepoint	NA Percentages of subjects Data was not collected at this timepoint	20 Percentages of subjects Interval 14.0 to 28.0
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup W (3 months; N=0,84,0)	NA Percentages of subjects Data was not collected at this timepoint	15 Percentages of subjects Interval 9.0 to 25.0	NA Percentages of subjects Data was not collected at this timepoint
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup W (5 months; N=162,0,0)	86 Percentages of subjects Interval 80.0 to 91.0	NA Percentages of subjects Data was not collected at this timepoint	NA Percentages of subjects Data was not collected at this timepoint
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup W (7 months; N=179,162,181)	74 Percentages of subjects Interval 67.0 to 81.0	99 Percentages of subjects Interval 96.0 to 100.0	1 Percentages of subjects Interval 0.014 to 3.0
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup Y (3 months; N=0,80,0)	NA Percentages of subjects Data was not collected at this timepoint	8 Percentages of subjects Interval 3.0 to 16.0	NA Percentages of subjects Data was not collected at this timepoint
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup Y (4 months; N=0,69,0)	NA Percentages of subjects Data was not collected at this timepoint	7 Percentages of subjects Interval 2.0 to 16.0	NA Percentages of subjects Data was not collected at this timepoint
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup Y (5 months; N=152,0,0)	67 Percentages of subjects Interval 59.0 to 75.0	NA Percentages of subjects Data was not collected at this timepoint	NA Percentages of subjects Data was not collected at this timepoint
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup Y (7 months; N=170,163,173)	48 Percentages of subjects Interval 40.0 to 55.0	94 Percentages of subjects Interval 90.0 to 97.0	0 Percentages of subjects Interval 0.0 to 2.0
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup A (4 months; N=0,70,0)	NA Percentages of subjects Data was not collected at this timepoint	4 Percentages of subjects Interval 1.0 to 12.0	NA Percentages of subjects Data was not collected at this timepoint
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup A (5 months; N=157,0,0)	43 Percentages of subjects Interval 35.0 to 51.0	NA Percentages of subjects Data was not collected at this timepoint	NA Percentages of subjects Data was not collected at this timepoint
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup A (7 months; N=169,157,171)	23 Percentages of subjects Interval 17.0 to 30.0	84 Percentages of subjects Interval 77.0 to 89.0	1 Percentages of subjects Interval 0.015 to 3.0
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup C (baseline; N=0,0,167)	NA Percentages of subjects Data was not collected at this timepoint	NA Percentages of subjects Data was not collected at this timepoint	9 Percentages of subjects Interval 5.0 to 14.0
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup C (3 months; N=0,85,0)	NA Percentages of subjects Data was not collected at this timepoint	28 Percentages of subjects Interval 19.0 to 39.0	NA Percentages of subjects Data was not collected at this timepoint
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup C (4 months; N=0,70,0)	NA Percentages of subjects Data was not collected at this timepoint	41 Percentages of subjects Interval 30.0 to 54.0	NA Percentages of subjects Data was not collected at this timepoint
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup C (5 months; N=170,0,0)	86 Percentages of subjects Interval 80.0 to 91.0	NA Percentages of subjects Data was not collected at this timepoint	NA Percentages of subjects Data was not collected at this timepoint
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup C (7 months)	71 Percentages of subjects Interval 64.0 to 78.0	95 Percentages of subjects Interval 91.0 to 98.0	1 Percentages of subjects Interval 0.014 to 3.0
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup Y (baseline; N=0,0,150)	NA Percentages of subjects Data was not collected at this timepoint	NA Percentages of subjects Data was not collected at this timepoint	7 Percentages of subjects Interval 4.0 to 13.0

SECONDARY outcome

Timeframe: Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.

Population: Analysis was done on the Infant PPS.

Antibody levels were assessed in terms of geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W and Y at baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.

Outcome measures

Measure	MenACWY4 n=185 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 n=176 Participants Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines n=187 Participants Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup A (3 months; N=0,82,0)	NA Titers Data was not collected at this timepoint	2.63 Titers Interval 2.2 to 3.15	NA Titers Data was not collected at this timepoint
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup A (4 months; N=0,70,0)	NA Titers Data was not collected at this timepoint	2.18 Titers Interval 2.0 to 2.37	NA Titers Data was not collected at this timepoint
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup A (5 months; N=157,0,0)	7.09 Titers Interval 5.62 to 8.94	NA Titers Data was not collected at this timepoint	NA Titers Data was not collected at this timepoint
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup A (7 months; N=169,157,171)	3.68 Titers Interval 3.17 to 4.29	28 Titers Interval 23.0 to 35.0	2.02 Titers Interval 1.98 to 2.06
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup C (baseline; N=0,0,167)	NA Titers Data was not collected at this timepoint	NA Titers Data was not collected at this timepoint	2.52 Titers Interval 2.28 to 2.78
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup C (7 months)	17 Titers Interval 14.0 to 22.0	86 Titers Interval 70.0 to 104.0	2.03 Titers Interval 1.97 to 2.08
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup W (baseline; N=0,0,157)	NA Titers Data was not collected at this timepoint	NA Titers Data was not collected at this timepoint	3.32 Titers Interval 2.82 to 3.9
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup W (3 months; N=0,84,0)	NA Titers Data was not collected at this timepoint	3 Titers Interval 2.48 to 3.61	NA Titers Data was not collected at this timepoint
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup W (4 months;N=0,71,0)	NA Titers Data was not collected at this timepoint	4.38 Titers Interval 3.42 to 5.61	NA Titers Data was not collected at this timepoint
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup W (5 months; N=162,0,0)	55 Titers Interval 42.0 to 71.0	NA Titers Data was not collected at this timepoint	NA Titers Data was not collected at this timepoint
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup W (7 months; N=179,162,181)	17 Titers Interval 14.0 to 21.0	90 Titers Interval 77.0 to 104.0	2.04 Titers Interval 1.96 to 2.11
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup Y (baseline; N=0,0,150)	NA Titers Data was not collected at this timepoint	NA Titers Data was not collected at this timepoint	2.47 Titers Interval 2.25 to 2.7
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup Y (3 months; N=0,80,0)	NA Titers Data was not collected at this timepoint	2.5 Titers Interval 2.14 to 2.93	NA Titers Data was not collected at this timepoint
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup Y (4 months; N=0,69,0)	NA Titers Data was not collected at this timepoint	2.46 Titers Interval 2.16 to 2.79	NA Titers Data was not collected at this timepoint
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup Y (5 months; N=152,0,0)	20 Titers Interval 15.0 to 26.0	NA Titers Data was not collected at this timepoint	NA Titers Data was not collected at this timepoint
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup Y (7 months; N=170,163,173)	7.56 Titers Interval 6.29 to 9.08	52 Titers Interval 43.0 to 64.0	2 Titers Interval 2.0 to 2.0
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup A (baseline; N=0,0,166)	NA Titers Data was not collected at this timepoint	NA Titers Data was not collected at this timepoint	2.18 Titers Interval 2.05 to 2.33
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup C (3 months; N=0,85,0)	NA Titers Data was not collected at this timepoint	4.79 Titers Interval 3.71 to 6.19	NA Titers Data was not collected at this timepoint
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup C (4 months; N=0,70,0)	NA Titers Data was not collected at this timepoint	6.44 Titers Interval 4.83 to 8.59	NA Titers Data was not collected at this timepoint
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. Serogroup C (5 months; N=170,0,0)	50 Titers Interval 39.0 to 64.0	NA Titers Data was not collected at this timepoint	NA Titers Data was not collected at this timepoint

SECONDARY outcome

Timeframe: 12 months of age.

Population: Analysis was done on the Toddler PPS.

Percentage of subjects with hSBA ≥1:8 against N meningitis serogroups A, C, W and Y was assessed following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.

Outcome measures

Measure	MenACWY4 n=149 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 n=147 Participants Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. Serogroup A (N=141,138)	6 Percentage of subjects Interval 2.0 to 11.0	22 Percentage of subjects Interval 15.0 to 30.0	—
Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. Serogroup C	19 Percentage of subjects Interval 13.0 to 27.0	48 Percentage of subjects Interval 39.0 to 56.0	—
Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. Serogroup W (N=149,142)	33 Percentage of subjects Interval 25.0 to 41.0	66 Percentage of subjects Interval 58.0 to 74.0	—
Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. Serogroup Y (N=145,139)	25 Percentage of subjects Interval 18.0 to 33.0	55 Percentage of subjects Interval 47.0 to 64.0	—

SECONDARY outcome

Timeframe: 12 months of age

Population: Analysis was done on the Toddler PPS.

The immune response was assessed in terms of GMTs against N. meningitidis serogroups A, C, W and Y following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.

Outcome measures

Measure	MenACWY4 n=149 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 n=147 Participants Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. Serogroup A (N=141,138)	2.28 Titers Interval 2.09 to 2.49	3.65 Titers Interval 3.08 to 4.33	—
Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. Serogroup C	3.54 Titers Interval 2.99 to 4.17	8.55 Titers Interval 6.75 to 11.0	—
Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. Serogroup W (N=149,142)	5.41 Titers Interval 4.39 to 6.67	13 Titers Interval 11.0 to 16.0	—
Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. Serogroup Y (N=145,139)	3.82 Titers Interval 3.24 to 4.49	9.65 Titers Interval 7.79 to 12.0	—

SECONDARY outcome

Timeframe: 13 months of age

Population: Analysis was done on the Toddler PPS.

Immune response was assessed in terms of GMTs against N meningitis serogroups A, C, W and Y at 1 month after completion of a 3- and 4- dose series of MenACWY.

Outcome measures

Measure	MenACWY4 n=160 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 n=152 Participants Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. Serogroup C	124 Titers Interval 99.0 to 156.0	160 Titers Interval 130.0 to 198.0	—
GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. Serogroup W (N=153,138)	248 Titers Interval 202.0 to 303.0	244 Titers Interval 195.0 to 305.0	—
GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. Serogroup Y (N=154,146)	212 Titers Interval 175.0 to 258.0	254 Titers Interval 203.0 to 318.0	—
GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. Serogroup A (N=146,141)	59 Titers Interval 45.0 to 77.0	94 Titers Interval 76.0 to 117.0	—

SECONDARY outcome

Timeframe: 13 months of age

Population: Analysis was done on the Toddler PPS.

The immune response was assessed in terms of percentage of subjects with 4-fold increase in hSBA titers between post and pre toddler dose against N meningitis serogroups A, C, W and Y, 1 month after completing a 3- or 4-dose series of MenACWY.

Outcome measures

Measure	MenACWY4 n=147 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 n=147 Participants Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. Serogroup A (N=127,129)	88 Percentage of subjects Interval 81.0 to 93.0	95 Percentage of subjects Interval 90.0 to 98.0	—
Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. Serogroup C	93 Percentage of subjects Interval 88.0 to 97.0	91 Percentage of subjects Interval 85.0 to 95.0	—
Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. Serogroup W (N=140,131)	98 Percentage of subjects Interval 94.0 to 100.0	90 Percentage of subjects Interval 84.0 to 95.0	—
Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. Serogroup Y (N=139,136)	100 Percentage of subjects Interval 97.0 to 100.0	96 Percentage of subjects Interval 91.0 to 98.0	—

SECONDARY outcome

Timeframe: 7 months of age.

Population: Analysis was done on the Infant PPS.

Percentage of subjects with IgG concentration ≥ 0.35 μg/mL against pneumococcal conjugate vaccine (PCV-13) antigens at 7 Months of age following concomitant administration of 2 or 3 doses of MenACWY with PCV-13.

Outcome measures

Measure	MenACWY4 n=160 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 n=137 Participants Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines n=158 Participants Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 5 (N=156,133,154)	84 Percentage of subjects Interval 77.3 to 89.4	93.2 Percentage of subjects Interval 87.5 to 96.9	88.3 Percentage of subjects Interval 82.2 to 92.9
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 14 (N=158,136,158)	99.4 Percentage of subjects Interval 96.5 to 100.0	100 Percentage of subjects Interval 97.3 to 100.0	97.5 Percentage of subjects Interval 93.6 to 99.3
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 18C (N=158,136,157)	97.5 Percentage of subjects Interval 93.6 to 99.3	97.8 Percentage of subjects Interval 93.7 to 99.5	100 Percentage of subjects Interval 97.7 to 100.0
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 19A (N=158,135,156)	95.6 Percentage of subjects Interval 91.1 to 98.2	92.6 Percentage of subjects Interval 86.8 to 96.4	98.1 Percentage of subjects Interval 94.5 to 99.6
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 19F (N=159,136,158)	100 Percentage of subjects Interval 97.7 to 100.0	100 Percentage of subjects Interval 97.3 to 100.0	99.4 Percentage of subjects Interval 96.5 to 100.0
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 23F (N=158,136,158)	93 Percentage of subjects Interval 87.9 to 96.5	95.6 Percentage of subjects Interval 90.6 to 98.4	91.1 Percentage of subjects Interval 85.6 to 95.1
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 1 (N=159,136,156)	93.7 Percentage of subjects Interval 88.7 to 96.9	100 Percentage of subjects Interval 97.3 to 100.0	94.2 Percentage of subjects Interval 89.3 to 97.3
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 3 (N=150,129,147)	79.3 Percentage of subjects Interval 72.0 to 85.5	87.6 Percentage of subjects Interval 80.6 to 92.7	82.3 Percentage of subjects Interval 75.2 to 88.1
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 4 (N=160,137,157)	94.4 Percentage of subjects Interval 89.6 to 97.4	97.1 Percentage of subjects Interval 92.7 to 99.2	96.8 Percentage of subjects Interval 92.7 to 99.0
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 6A (N=159,136,156)	98.1 Percentage of subjects Interval 94.6 to 99.6	99.3 Percentage of subjects Interval 96.0 to 100.0	98.1 Percentage of subjects Interval 94.5 to 99.6
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 6B (N=160,137,157)	84.4 Percentage of subjects Interval 77.8 to 89.6	94.9 Percentage of subjects Interval 89.8 to 97.9	84.7 Percentage of subjects Interval 78.1 to 90.0
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 7F (N=158,136,156)	100 Percentage of subjects Interval 97.7 to 100.0	100 Percentage of subjects Interval 97.3 to 100.0	99.4 Percentage of subjects Interval 96.5 to 100.0
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. 9V (N=159,136,157)	89.3 Percentage of subjects Interval 83.4 to 93.6	96.3 Percentage of subjects Interval 91.6 to 98.8	92.4 Percentage of subjects Interval 87.0 to 96.0

SECONDARY outcome

Timeframe: 13 months of age.

Population: Analysis was done on the Toddler PPS.

Geometric mean concentrations (GMCs) of antibodies against PCV-13 vaccine antigens at 13 months of age following concomitant administration of a 3- or 4-dose series of MenACWY with PCV-13.

Outcome measures

Measure	MenACWY4 n=147 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 n=117 Participants Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines n=124 Participants Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 1 (N=145,116,123)	2 µg/mL Interval 1.7 to 2.36	2.16 µg/mL Interval 1.83 to 2.56	2.14 µg/mL Interval 1.8 to 2.54
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 3 (N=139,113,118)	0.88 µg/mL Interval 0.74 to 1.05	0.97 µg/mL Interval 0.81 to 1.15	0.77 µg/mL Interval 0.64 to 0.93
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 4 (N=146,117,123)	1.19 µg/mL Interval 0.99 to 1.42	1.45 µg/mL Interval 1.21 to 1.75	1.53 µg/mL Interval 1.27 to 1.86
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 6A (N=146,117,124)	6.89 µg/mL Interval 5.78 to 8.21	9.01 µg/mL Interval 7.52 to 11.0	8.16 µg/mL Interval 6.77 to 9.82
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 18C (N=146,116,123)	1.52 µg/mL Interval 1.28 to 1.8	2.34 µg/mL Interval 1.96 to 2.79	2.13 µg/mL Interval 1.78 to 2.55
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 19A (N=144,114,124)	5.51 µg/mL Interval 4.61 to 6.6	5.23 µg/mL Interval 4.34 to 6.3	5.39 µg/mL Interval 4.45 to 6.51
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 19F (N=147,117,124)	5.79 µg/mL Interval 4.9 to 6.85	6.19 µg/mL Interval 5.21 to 7.35	5.8 µg/mL Interval 4.86 to 6.92
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 23F (N=147,117,124)	4.21 µg/mL Interval 3.49 to 5.09	4.84 µg/mL Interval 3.98 to 5.89	5.44 µg/mL Interval 4.45 to 6.65
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 5 (N=140,114,117)	1.29 µg/mL Interval 1.11 to 1.49	1.35 µg/mL Interval 1.16 to 1.57	1.26 µg/mL Interval 1.08 to 1.48
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 6B (N=147,117,124)	4.29 µg/mL Interval 3.6 to 5.11	5.23 µg/mL Interval 4.36 to 6.27	5.04 µg/mL Interval 4.18 to 6.08
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 7F (N=147,116,123)	3.96 µg/mL Interval 3.42 to 4.58	5.14 µg/mL Interval 4.41 to 5.98	4.95 µg/mL Interval 4.23 to 5.78
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 9V (N=146,117,123)	1.37 µg/mL Interval 1.17 to 1.61	1.85 µg/mL Interval 1.56 to 2.18	1.73 µg/mL Interval 1.46 to 2.05
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. 14 (N=147,117,124)	7.76 µg/mL Interval 6.51 to 9.26	7.86 µg/mL Interval 6.55 to 9.43	7.54 µg/mL Interval 6.25 to 9.09

SECONDARY outcome

Timeframe: Within 7 days

Population: Analysis was done on the Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data

Safety was assessed as the percentages of subjects who reported severe solicited systemic adverse events within 30 minutes through day 7 of MenACWY administration with concomitant vaccines vs. concomitant vaccines alone.

Outcome measures

Measure	MenACWY4 n=238 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 n=240 Participants Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines n=230 Participants Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.	18 Percentage of subjects	21 Percentage of subjects	18 Percentage of subjects

SECONDARY outcome

Timeframe: Day 1 through Day 7

Population: Analysis was done on Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data

Safety was assessed as the number of subjects who reported solicited local or systemic adverse events between 6 hours and day 7 after administration of MenACWY with concomitant vaccines vs. concomitant vaccines alone.

Outcome measures

Measure	MenACWY4 n=238 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 n=239 Participants Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines n=229 Participants Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. Injection site erythema	72 Subjects	64 Subjects	79 Subjects
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. Injection site induration	60 Subjects	40 Subjects	74 Subjects
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. Tenderness	117 Subjects	127 Subjects	126 Subjects
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. Change in eating habits (N=238,238,229)	104 Subjects	104 Subjects	93 Subjects
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. Sleepiness	153 Subjects	147 Subjects	149 Subjects
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. Persistent crying	140 Subjects	137 Subjects	112 Subjects
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. Irritability	173 Subjects	171 Subjects	152 Subjects
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. Vomiting	68 Subjects	52 Subjects	54 Subjects
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. Diarrhea	89 Subjects	69 Subjects	68 Subjects
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. Fever (≥38.0°C)	55 Subjects	52 Subjects	41 Subjects
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. Rash	23 Subjects	19 Subjects	18 Subjects
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. Use of analgesic/antipyretic	162 Subjects	173 Subjects	153 Subjects

SECONDARY outcome

Timeframe: 13 months of age

Population: Analysis was done on the Unsolicited Safety Set - All subjects in the Exposed Set with unsolicited adverse event data.

Outcome measures

Measure	MenACWY4 n=242 Participants All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	MenACWY4 n=252 Participants Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines n=239 Participants Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. At least possibly related AEs	24 Subjects	32 Subjects	10 Subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. SAEs	11 Subjects	19 Subjects	11 Subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. Medically attended AEs	210 Subjects	211 Subjects	198 Subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. AEs resulting in premature withdrawal	1 Subjects	2 Subjects	2 Subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. Any AE	219 Subjects	220 Subjects	209 Subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. Deaths	0 Subjects	0 Subjects	1 Subjects

Adverse Events

MenACWY3

Serious events: 11 serious events

Other events: 238 other events

Deaths: 0 deaths

MenACWY4

Serious events: 19 serious events

Other events: 233 other events

Deaths: 0 deaths

Routine Vaccines

Serious events: 11 serious events

Other events: 228 other events

Deaths: 0 deaths

Serious adverse events

Measure	MenACWY3 n=242 participants at risk Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.	MenACWY4 n=252 participants at risk Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines n=239 participants at risk Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Infections and infestations Gastroenteritis viral	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.40% 1/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Influenza	0.41% 1/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Congenital, familial and genetic disorders Congenital megacolon	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Congenital, familial and genetic disorders Krabbe's disease	0.41% 1/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Congenital, familial and genetic disorders Laryngomalacia	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Gastrointestinal disorders Anal fissure	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
General disorders Pyrexia	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.40% 1/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Abdominal abscess	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.40% 1/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Abscess	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.40% 1/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Atypical pneumonia	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.40% 1/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Bronchiolitis	0.83% 2/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.79% 2/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	1.7% 4/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Clostridium difficile colitis	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.40% 1/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Croup infectious	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Gastroenteritis	0.41% 1/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Otitis media acute	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Pneumonia	0.41% 1/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.40% 1/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Rectal abscess	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.40% 1/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Respiratory synctial virus bronchiolitis	0.83% 2/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	2.0% 5/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.84% 2/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Staphylococcal abscess	0.41% 1/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Injury, poisoning and procedural complications Skull fracture	0.41% 1/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Metabolism and nutrition disorders Dehydration	0.41% 1/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Metabolism and nutrition disorders Failure to thrive	0.41% 1/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Nervous system disorders Convulsion	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.79% 2/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Nervous system disorders Nystagmus	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.40% 1/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Psychiatric disorders Breath holding	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.40% 1/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.40% 1/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.41% 1/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.00% 0/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	0.42% 1/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.

Other adverse events

Measure	MenACWY3 n=242 participants at risk Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.	MenACWY4 n=252 participants at risk Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Routine Vaccines n=239 participants at risk Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
Ear and labyrinth disorders Ear pain	5.4% 13/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	4.0% 10/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	3.8% 9/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Eye disorders Conjunctivitis	17.4% 42/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	9.9% 25/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	16.7% 40/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Gastrointestinal disorders Constipation	4.1% 10/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	8.3% 21/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	7.9% 19/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Gastrointestinal disorders Diarrhea	42.6% 103/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	31.0% 78/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	33.5% 80/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.5% 11/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	5.6% 14/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	11.3% 27/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Gastrointestinal disorders Teething	6.2% 15/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	5.2% 13/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	7.9% 19/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Gastrointestinal disorders Vomiting	31.4% 76/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	27.0% 68/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	28.0% 67/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
General disorders Crying	57.9% 140/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	54.8% 138/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	46.9% 112/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
General disorders Injection site erythema	36.0% 87/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	31.7% 80/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	37.2% 89/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
General disorders Injection site induration	26.9% 65/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	17.9% 45/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	33.1% 79/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
General disorders Injection site pain	56.6% 137/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	55.6% 140/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	57.7% 138/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
General disorders Irritability	74.8% 181/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	71.0% 179/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	65.7% 157/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
General disorders Pyrexia	36.4% 88/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	34.5% 87/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	28.9% 69/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Bronchiolitis	14.0% 34/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	14.3% 36/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	12.6% 30/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Bronchitis	3.3% 8/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	7.5% 19/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	7.1% 17/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Candida nappy rash	5.4% 13/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	2.4% 6/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	2.9% 7/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Croup Infectious	5.4% 13/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	6.3% 16/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	6.7% 16/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Gastroenteritis	9.1% 22/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	7.1% 18/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	11.3% 27/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Otitis media	38.8% 94/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	30.6% 77/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	37.2% 89/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Otitis media acute	9.5% 23/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	7.5% 19/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	6.7% 16/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Rhinitis	8.3% 20/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	6.7% 17/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	6.3% 15/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Sinusitis	3.7% 9/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	6.7% 17/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	2.9% 7/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Upper respiratory tract infection	43.4% 105/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	42.5% 107/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	44.4% 106/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Viral infection	15.7% 38/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	12.7% 32/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	12.6% 30/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Viral rash	4.1% 10/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	4.0% 10/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	5.4% 13/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Nervous system disorders Somnolence	66.9% 162/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	61.1% 154/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	66.1% 158/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Psychiatric disorders Eating disorder	43.0% 104/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	41.3% 104/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	38.9% 93/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Respiratory, thoracic and mediastinal disorders Cough	13.2% 32/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	12.7% 32/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	15.5% 37/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.6% 16/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	7.1% 18/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	5.9% 14/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Respiratory, thoracic and mediastinal disorders Wheezing	5.0% 12/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	3.6% 9/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	6.7% 16/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Skin and subcutaneous tissue disorders Dermatitis atopic	4.1% 10/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	4.4% 11/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	5.9% 14/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Skin and subcutaneous tissue disorders Dermatitis diaper	15.7% 38/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	12.3% 31/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	9.2% 22/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Skin and subcutaneous tissue disorders Eczema	6.6% 16/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	7.5% 19/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	8.4% 20/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Skin and subcutaneous tissue disorders Rash	12.0% 29/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	12.3% 31/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	14.6% 35/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.
Infections and infestations Candidiasis	5.8% 14/242 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	7.9% 20/252 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.	8.8% 21/239 • 13 months of age Solicited local and systemic and unsolicited AEs were assessed for 7 days postvaccination. AEs and SAEs were assessed throughout the study period. Out of a total of 751 subjects enrolled in the study, 733 (98%) subjects were exposed to at least 1 study vaccination and provided safety information.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: RegistryContactVaccinesUS@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place