Trial Outcomes & Findings for Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers (NCT NCT03691610)

Last Updated: 2024-06-25

Results Overview

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase from baseline for participant with pre-vaccination hSBA titer \>= 1:8.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

950 participants

Primary outcome timeframe

Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months

Results posted on

2024-06-25

Participant Flow

The study was conducted at 47 centers in the United States and Puerto Rico between 04 October 2018 and 23 October 2023.

A total of 950 participants were enrolled and randomized in the study.

Participant milestones

Participant milestones
Measure	Infants: Group 1 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 milliliter (mL) intramuscular (IM) injection at 6 to 7 month of age (MoA) and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Toddlers: Group 3 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.	Toddlers: Group 4 Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.
Overall Study STARTED	380	370	96	104
Overall Study COMPLETED	298	290	83	94
Overall Study NOT COMPLETED	82	80	13	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Infants: Group 1 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 milliliter (mL) intramuscular (IM) injection at 6 to 7 month of age (MoA) and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Toddlers: Group 3 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.	Toddlers: Group 4 Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.
Overall Study Adverse Event	0	1	0	0
Overall Study Protocol Deviation	15	8	1	2
Overall Study Withdrawal by Parent/Guardian	47	60	7	6
Overall Study Lost to Follow-up	20	11	5	2

Baseline Characteristics

One participant in 'Infants: Group 1' reporting group had missing value of age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infants: Group 1 n=380 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=370 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Toddlers: Group 3 n=96 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.	Toddlers: Group 4 n=104 Participants Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.	Total n=950 Participants Total of all reporting groups
Age, Continuous	6.01 Units: months STANDARD_DEVIATION 0.700 • n=379 Participants • One participant in 'Infants: Group 1' reporting group had missing value of age.	6.02 Units: months STANDARD_DEVIATION 0.396 • n=370 Participants • One participant in 'Infants: Group 1' reporting group had missing value of age.	17.9 Units: months STANDARD_DEVIATION 0.632 • n=96 Participants • One participant in 'Infants: Group 1' reporting group had missing value of age.	17.9 Units: months STANDARD_DEVIATION 0.673 • n=104 Participants • One participant in 'Infants: Group 1' reporting group had missing value of age.	8.51 Units: months STANDARD_DEVIATION 4.87 • n=949 Participants • One participant in 'Infants: Group 1' reporting group had missing value of age.
Sex: Female, Male Female	180 Participants n=380 Participants	172 Participants n=370 Participants	48 Participants n=96 Participants	52 Participants n=104 Participants	452 Participants n=950 Participants
Sex: Female, Male Male	200 Participants n=380 Participants	198 Participants n=370 Participants	48 Participants n=96 Participants	52 Participants n=104 Participants	498 Participants n=950 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=380 Participants	1 Participants n=370 Participants	0 Participants n=96 Participants	0 Participants n=104 Participants	1 Participants n=950 Participants
Race/Ethnicity, Customized Asian	6 Participants n=380 Participants	6 Participants n=370 Participants	2 Participants n=96 Participants	1 Participants n=104 Participants	15 Participants n=950 Participants
Race/Ethnicity, Customized Black or African American	70 Participants n=380 Participants	68 Participants n=370 Participants	11 Participants n=96 Participants	11 Participants n=104 Participants	160 Participants n=950 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=380 Participants	0 Participants n=370 Participants	0 Participants n=96 Participants	0 Participants n=104 Participants	0 Participants n=950 Participants
Race/Ethnicity, Customized White	277 Participants n=380 Participants	264 Participants n=370 Participants	79 Participants n=96 Participants	87 Participants n=104 Participants	707 Participants n=950 Participants
Race/Ethnicity, Customized Mixed origin	14 Participants n=380 Participants	20 Participants n=370 Participants	4 Participants n=96 Participants	5 Participants n=104 Participants	43 Participants n=950 Participants
Race/Ethnicity, Customized Not Reported	10 Participants n=380 Participants	4 Participants n=370 Participants	0 Participants n=96 Participants	0 Participants n=104 Participants	14 Participants n=950 Participants
Race/Ethnicity, Customized Unknown	3 Participants n=380 Participants	7 Participants n=370 Participants	0 Participants n=96 Participants	0 Participants n=104 Participants	10 Participants n=950 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months

Population: Per-protocol analysis set 2 (PPAS2) was a subset of the full analysis set 2 (FAS2). The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (\>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Only participants with data collected for each specific serogroup are reported.

Outcome measures

Outcome measures
Measure	Infants: Group 1 n=143 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=128 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO Serogroup A	89.4 percentage of participants Interval 83.1 to 93.9	82.9 percentage of participants Interval 75.1 to 89.1
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO Serogroup C	99.3 percentage of participants Interval 95.9 to 100.0	97.6 percentage of participants Interval 93.2 to 99.5
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO Serogroup Y	98.6 percentage of participants Interval 94.9 to 99.8	97.7 percentage of participants Interval 93.3 to 99.5
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO Serogroup W	99.3 percentage of participants Interval 96.2 to 100.0	92.9 percentage of participants Interval 87.0 to 96.7

SECONDARY outcome

Timeframe: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO

Population: The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (\>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Only participants with data collected for each specific serogroup are reported.

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Seroprotection rate was defined as percentage of participants with hSBA titers \>= 1:8.

Outcome measures

Outcome measures
Measure	Infants: Group 1 n=171 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=160 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO Serogroup A	95.3 percentage of participants Interval 90.9 to 97.9	93.0 percentage of participants Interval 87.9 to 96.5
Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO Serogroup C	100 percentage of participants Interval 97.7 to 100.0	98.1 percentage of participants Interval 94.6 to 99.6
Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO Serogroup Y	100 percentage of participants Interval 97.9 to 100.0	97.5 percentage of participants Interval 93.7 to 99.3
Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO Serogroup W	100 percentage of participants Interval 97.9 to 100.0	95.6 percentage of participants Interval 91.1 to 98.2

SECONDARY outcome

Timeframe: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO

Population: PPAS1 was a subset of FAS1. FAS1 included all randomized participants who received at least 1 dose of study vaccine in infancy (\< 12 MOA) and had a valid post vaccination serology result in infancy. PPAS2 analysis set. PPAS3 was a subset of FAS3. FAS3 included all randomized participants who received at least 1 dose of study vaccine in infancy and had a valid pre-vaccination serology result at visit 3. Only participants with data collected for each serogroup at specific timepoint are reported.

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 and \>= 1:8 were analyzed. PPAS1= Per-Protocol Analysis Set 1; FAS1= Full analysis set 1; PPAS3= Per-Protocol Analysis Set 3; and FAS3= Full analysis set 3.

Outcome measures

Outcome measures
Measure	Infants: Group 1 n=171 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=160 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS1, Serogroup A: >=1:4	64.6 percentage of participants Interval 55.8 to 72.8	55.3 percentage of participants Interval 46.4 to 64.0
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS1, Serogroup A: >=1:8	54.6 percentage of participants Interval 45.7 to 63.4	37.9 percentage of participants Interval 29.6 to 46.7
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS1, Serogroup C: >=1:4	96.9 percentage of participants Interval 92.1 to 99.1	93.2 percentage of participants Interval 87.5 to 96.9
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS1, Serogroup C: >=1:8	96.9 percentage of participants Interval 92.1 to 99.1	90.2 percentage of participants Interval 83.9 to 94.7
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS1, Serogroup Y: >=1:4	70.4 percentage of participants Interval 61.6 to 78.2	43.0 percentage of participants Interval 34.3 to 52.0
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS1, Serogroup Y: >=1:8	60.8 percentage of participants Interval 51.7 to 69.4	26.6 percentage of participants Interval 19.1 to 35.1
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS1, Serogroup W: >=1:4	49.3 percentage of participants Interval 40.5 to 58.0	37.3 percentage of participants Interval 29.1 to 46.1
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS1, Serogroup W: >=1:8	38.1 percentage of participants Interval 29.8 to 46.8	28.4 percentage of participants Interval 20.9 to 36.8
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup A, Day 0: >=1:4	56.3 percentage of participants Interval 47.7 to 64.5	51.2 percentage of participants Interval 42.2 to 60.1
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup A, Day 0: >=1:8	29.2 percentage of participants Interval 21.9 to 37.3	24.4 percentage of participants Interval 17.2 to 32.8
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup A, Day 30: >=1:4	97.1 percentage of participants Interval 93.3 to 99.0	94.9 percentage of participants Interval 90.3 to 97.8
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup A, Day 30: >=1:8	95.3 percentage of participants Interval 90.9 to 97.9	93.0 percentage of participants Interval 87.9 to 96.5
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup C, Day 0: >=1:4	10.2 percentage of participants Interval 5.8 to 16.3	12.4 percentage of participants Interval 7.3 to 19.4
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup C, Day 0: >=1:8	6.1 percentage of participants Interval 2.8 to 11.3	7.0 percentage of participants Interval 3.2 to 12.8
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup C, Day 30: >=1:4	100 percentage of participants Interval 97.7 to 100.0	99.4 percentage of participants Interval 96.6 to 100.0
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup C, Day 30: >=1:8	100 percentage of participants Interval 97.7 to 100.0	98.1 percentage of participants Interval 94.6 to 99.6
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup Y, Day 0: >=1:4	15.4 percentage of participants Interval 10.0 to 22.3	12.3 percentage of participants Interval 7.2 to 19.2
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup Y, Day 0: >=1:8	8.7 percentage of participants Interval 4.7 to 14.5	6.2 percentage of participants Interval 2.7 to 11.8
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup Y, Day 30: >=1:4	100 percentage of participants Interval 97.9 to 100.0	98.1 percentage of participants Interval 94.6 to 99.6
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup Y, Day 30: >=1:8	100 percentage of participants Interval 97.9 to 100.0	97.5 percentage of participants Interval 93.7 to 99.3
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup W, Day 0: >=1:4	6.8 percentage of participants Interval 3.3 to 12.1	10.8 percentage of participants Interval 6.0 to 17.4
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup W, Day 0: >=1:8	4.7 percentage of participants Interval 1.9 to 9.5	6.2 percentage of participants Interval 2.7 to 11.8
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup W, Day 30: >=1:4	100 percentage of participants Interval 97.9 to 100.0	96.9 percentage of participants Interval 92.8 to 99.0
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS2, Serogroup W, Day 30: >=1:8	100 percentage of participants Interval 97.9 to 100.0	95.6 percentage of participants Interval 91.1 to 98.2
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS3, Serogroup A: >=1:4	87.4 percentage of participants Interval 79.4 to 93.1	85.7 percentage of participants Interval 76.8 to 92.2
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS3, Serogroup A: >=1:8	77.7 percentage of participants Interval 68.4 to 85.3	73.6 percentage of participants Interval 63.3 to 82.3
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS3, Serogroup C: >=1:4	99.0 percentage of participants Interval 94.8 to 100.0	77.7 percentage of participants Interval 67.9 to 85.6
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS3, Serogroup C: >=1:8	98.1 percentage of participants Interval 93.2 to 99.8	69.1 percentage of participants Interval 58.8 to 78.3
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS3, Serogroup Y: >=1:4	98.1 percentage of participants Interval 93.4 to 99.8	69.9 percentage of participants Interval 59.5 to 79.0
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS3, Serogroup Y: >=1:8	96.2 percentage of participants Interval 90.6 to 99.0	54.8 percentage of participants Interval 44.2 to 65.2
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS3, Serogroup W: >=1:4	98.1 percentage of participants Interval 93.4 to 99.8	61.3 percentage of participants Interval 50.6 to 71.2
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 PPAS3, Serogroup W: >=1:8	96.2 percentage of participants Interval 90.6 to 99.0	50.5 percentage of participants Interval 40.0 to 61.1

SECONDARY outcome

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.

Outcome measures

Outcome measures
Measure	Infants: Group 1 n=171 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=160 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup A	8.26 titer Interval 6.55 to 10.4	5.45 titer Interval 4.42 to 6.72
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup C	167 titer Interval 129.0 to 217.0	41.3 titer Interval 32.8 to 52.1
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup Y	8.36 titer Interval 6.61 to 10.6	3.79 titer Interval 3.2 to 4.49
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup W	5.51 titer Interval 4.39 to 6.92	3.82 titer Interval 3.22 to 4.52
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS2, Serogroup A: Day 0	4.73 titer Interval 3.92 to 5.72	4.64 titer Interval 3.74 to 5.74
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS2, Serogroup A: Day 30	184 titer Interval 143.0 to 237.0	119 titer Interval 90.6 to 157.0
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS2, Serogroup C: Day 0	2.57 titer Interval 2.21 to 2.99	2.48 titer Interval 2.2 to 2.79
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS2, Serogroup C: Day 30	1473 titer Interval 1236.0 to 1756.0	319 titer Interval 263.0 to 388.0
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS2, Serogroup Y: Day 0	2.54 titer Interval 2.27 to 2.83	2.37 titer Interval 2.16 to 2.6
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS2, Serogroup Y: Day 30	423 titer Interval 358.0 to 499.0	133 titer Interval 107.0 to 166.0
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS2, Serogroup W: Day 0	2.23 titer Interval 2.05 to 2.42	2.31 titer Interval 2.13 to 2.51
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS2, Serogroup W: Day 30	442 titer Interval 367.0 to 533.0	106 titer Interval 83.4 to 135.0
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS3: Serogroup A	20.1 titer Interval 14.7 to 27.4	14.9 titer Interval 11.0 to 20.3
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS3: Serogroup C	150 titer Interval 117.0 to 193.0	12.7 titer Interval 9.63 to 16.8
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS3: Serogroup Y	46.2 titer Interval 36.3 to 58.6	6.74 titer Interval 5.43 to 8.36
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y PPAS3: Serogroup W	46.8 titer Interval 36.1 to 60.5	6.16 titer Interval 4.87 to 7.8

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Infants: Group 1 n=171 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=160 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS1, Serogroup A: >=1:4	64.6 percentage of participants	55.3 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS1, Serogroup A: >=1:128	3.1 percentage of participants	3.0 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS1, Serogroup C: >=1:4	96.9 percentage of participants	93.2 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS1, Serogroup C: >=1:128	67.7 percentage of participants	32.3 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup Y, Day 30: >=1:128	90.0 percentage of participants	58.8 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS1, Serogroup Y: >=1:4	70.4 percentage of participants	43.0 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS1, Serogroup Y: >=1:128	5.6 percentage of participants	0.8 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS1, Serogroup W: >=1:4	49.3 percentage of participants	37.3 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS1, Serogroup W: >=1:128	4.5 percentage of participants	0 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup A, Day 0: >=1:4	56.3 percentage of participants	51.2 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup A, Day 0: >=1:128	4.9 percentage of participants	3.1 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup A, Day 30: >=1:4	97.1 percentage of participants	94.9 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup A, Day 30: >=1:128	68.8 percentage of participants	62.7 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup C, Day 0: >=1:4	10.2 percentage of participants	12.4 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup C, Day 0: >=1:128	2.0 percentage of participants	0 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup C, Day 30: >=1:4	100 percentage of participants	99.4 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup C, Day 30: >=1:128	98.1 percentage of participants	88.1 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup Y, Day 0: >=1:4	15.4 percentage of participants	12.3 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup Y, Day 0: >=1:128	0.7 percentage of participants	0 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup Y, Day 30: >=1:4	100 percentage of participants	98.1 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup W, Day 0: >=1:4	6.8 percentage of participants	10.8 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup W, Day 0: >=1:128	0.7 percentage of participants	0 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup W, Day 30: >=1:4	100 percentage of participants	96.9 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS2, Serogroup W, Day 30: >=1:128	90.6 percentage of participants	56.0 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS3, Serogroup A: >=1:4	87.4 percentage of participants	85.7 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS3, Serogroup A: >=1:128	18.4 percentage of participants	12.1 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS3, Serogroup C: >=1:4	99.0 percentage of participants	77.7 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS3, Serogroup C: >=1:128	69.2 percentage of participants	6.4 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS3, Serogroup Y: >=1:4	98.1 percentage of participants	69.9 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS3, Serogroup Y: >=1:128	27.4 percentage of participants	1.1 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS3, Serogroup W: >=1:4	98.1 percentage of participants	61.3 percentage of participants
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 PPAS3, Serogroup W: >=1:128	33.0 percentage of participants	3.2 percentage of participants

SECONDARY outcome

Timeframe: PPAS1: At 30 days post first dose (6 to 7 MoA); and PPAS2: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO

Population: PPAS1 was a subset of FAS1. FAS1 included all randomized participants who received at least 1 dose of study vaccine in infancy (\<12 MOA) and had a valid post vaccination serology result in infancy. PPAS2 was a subset of FAS2. FAS2 included all randomized participants who received at least 1 dose of study vaccine in second year of life (\>=12 MOA) and had a valid post vaccination serology result in second year of life. Only participants with data collected for each specific serogroup are reported.

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 4-fold increase from baseline (pre-vaccination) were analyzed.

Outcome measures

Outcome measures
Measure	Infants: Group 1 n=143 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=128 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination PPAS1: Serogroup A	30.6 percentage of participants Interval 22.1 to 40.2	15.3 percentage of participants Interval 9.2 to 23.4
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination PPAS1: Serogroup C	92.3 percentage of participants Interval 85.4 to 96.6	81.3 percentage of participants Interval 72.6 to 88.2
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination PPAS1: Serogroup Y	30.4 percentage of participants Interval 21.7 to 40.3	7.5 percentage of participants Interval 3.3 to 14.3
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination PPAS1: Serogroup W	18.5 percentage of participants Interval 11.7 to 27.1	8.0 percentage of participants Interval 3.7 to 14.7
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination PPAS2: Serogroup A	89.4 percentage of participants Interval 83.1 to 93.9	82.9 percentage of participants Interval 75.1 to 89.1
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination PPAS2: Serogroup C	99.3 percentage of participants Interval 95.9 to 100.0	97.6 percentage of participants Interval 93.2 to 99.5
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination PPAS2: Serogroup Y	98.6 percentage of participants Interval 94.9 to 99.8	97.7 percentage of participants Interval 93.3 to 99.5
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination PPAS2: Serogroup W	99.3 percentage of participants Interval 96.2 to 100.0	92.9 percentage of participants Interval 87.0 to 96.7

SECONDARY outcome

Timeframe: At 30 days post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO

Population: The PPAS1 was a subset of the FAS1. The FAS1 included all randomized participants who received at least 1 dose of the study vaccine in infancy (\< 12 MOA) and had a valid post vaccination serology result in infancy. Only participants with data collected for each specific serogroup are reported.

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as \>= 4-fold increase from baseline (pre-vaccination) were analyzed.

Outcome measures

Outcome measures
Measure	Infants: Group 1 n=108 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=112 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO Serogroup A	30.6 percentage of participants Interval 22.1 to 40.2	15.3 percentage of participants Interval 9.2 to 23.4
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO Serogroup C	92.3 percentage of participants Interval 85.4 to 96.6	81.3 percentage of participants Interval 72.6 to 88.2
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO Serogroup Y	30.4 percentage of participants Interval 21.7 to 40.3	7.5 percentage of participants Interval 3.3 to 14.3
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO Serogroup W	18.5 percentage of participants Interval 11.7 to 27.1	8.0 percentage of participants Interval 3.7 to 14.7

SECONDARY outcome

Timeframe: Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra

Outcome measures

Outcome measures
Measure	Infants: Group 1 n=61 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=65 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup A, Day 0: >=1:4	54.2 percentage of participants Interval 40.8 to 67.3	33.9 percentage of participants Interval 22.1 to 47.4
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup A, Day 0: >=1:8	28.8 percentage of participants Interval 17.8 to 42.1	18.6 percentage of participants Interval 9.7 to 30.9
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup A, Day 30: >=1:4	93.4 percentage of participants Interval 84.1 to 98.2	76.6 percentage of participants Interval 64.3 to 86.2
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup A, Day 30: >=1:8	88.5 percentage of participants Interval 77.8 to 95.3	62.5 percentage of participants Interval 49.5 to 74.3
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup C, Day 0: >=1:4	3.4 percentage of participants Interval 0.4 to 11.7	10.2 percentage of participants Interval 3.8 to 20.8
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup C, Day 0: >=1:8	1.7 percentage of participants Interval 0.0 to 9.1	5.1 percentage of participants Interval 1.1 to 14.1
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup C, Day 30: >=1:4	100 percentage of participants Interval 94.1 to 100.0	98.5 percentage of participants Interval 91.7 to 100.0
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup C, Day 30: >=1:8	100 percentage of participants Interval 94.1 to 100.0	98.5 percentage of participants Interval 91.7 to 100.0
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup Y, Day 0: >=1:4	11.9 percentage of participants Interval 4.9 to 22.9	10.2 percentage of participants Interval 3.8 to 20.8
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup Y, Day 0: >=1:8	8.5 percentage of participants Interval 2.8 to 18.7	8.5 percentage of participants Interval 2.8 to 18.7
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup Y, Day 30: >=1:4	100 percentage of participants Interval 94.1 to 100.0	93.8 percentage of participants Interval 85.0 to 98.3
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup Y, Day 30: >=1:8	100 percentage of participants Interval 94.1 to 100.0	92.3 percentage of participants Interval 83.0 to 97.5
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup W, Day 0: >=1:4	1.7 percentage of participants Interval 0.0 to 9.1	3.4 percentage of participants Interval 0.4 to 11.7
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup W, Day 0: >=1:8	0 percentage of participants Interval 0.0 to 6.1	1.7 percentage of participants Interval 0.0 to 9.1
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup W, Day 30: >=1:4	100 percentage of participants Interval 94.1 to 100.0	86.2 percentage of participants Interval 75.3 to 93.5
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 Serogroup W, Day 30: >=1:8	100 percentage of participants Interval 94.1 to 100.0	84.6 percentage of participants Interval 73.5 to 92.4

SECONDARY outcome

Timeframe: Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.

Outcome measures

Outcome measures
Measure	Infants: Group 1 n=61 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=65 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Serogroup A: Day 0	4.29 titer Interval 3.36 to 5.49	3.43 titer Interval 2.61 to 4.51
Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Serogroup A: Day 30	45.0 titer Interval 29.8 to 68.0	13.2 titer Interval 8.72 to 19.9
Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Serogroup C: Day 0	2.10 titer Interval 1.95 to 2.26	2.41 titer Interval 2.01 to 2.9
Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Serogroup C: Day 30	1727 titer Interval 1300.0 to 2294.0	59.4 titer Interval 44.3 to 79.6
Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Serogroup Y: Day 0	2.44 titer Interval 2.07 to 2.88	2.44 titer Interval 2.05 to 2.91
Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Serogroup Y: Day 30	284 titer Interval 218.0 to 369.0	45.5 titer Interval 32.9 to 62.8
Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Serogroup W: Day 0	2.02 titer Interval 1.98 to 2.07	2.12 titer Interval 1.93 to 2.34
Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Serogroup W: Day 30	202 titer Interval 152.0 to 267.0	25.0 titer Interval 17.6 to 35.7

SECONDARY outcome

Timeframe: Baseline (Day 0) and at 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra

Outcome measures

Outcome measures
Measure	Infants: Group 1 n=61 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=65 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup A, Day 0: >=1:4	54.2 percentage of participants	33.9 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup A, Day 0: >=1:128	0 percentage of participants	3.4 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup A, Day 30: >=1:4	93.4 percentage of participants	76.6 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup A, Day 30: >=1:128	32.8 percentage of participants	14.1 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup C, Day 0: >=1:4	3.4 percentage of participants	10.2 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup C, Day 0: >=1:128	0 percentage of participants	1.7 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup C, Day 30: >=1:4	100 percentage of participants	98.5 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup C, Day 30: >=1:128	100 percentage of participants	32.3 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup Y, Day 0: >=1:4	11.9 percentage of participants	10.2 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup Y, Day 0: >=1:128	0 percentage of participants	0 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup Y, Day 30: >=1:4	100 percentage of participants	93.8 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup Y, Day 30: >=1:128	85.2 percentage of participants	24.6 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup W, Day 0: >=1:4	1.7 percentage of participants	3.4 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup W, Day 0: >=1:128	0 percentage of participants	0 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup W, Day 30: >=1:4	100 percentage of participants	86.2 percentage of participants
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 Serogroup W, Day 30: >=1:128	78.7 percentage of participants	13.8 percentage of participants

SECONDARY outcome

Timeframe: At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra

Outcome measures

Outcome measures
Measure	Infants: Group 1 n=59 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=59 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination Serogroup A	72.9 percentage of participants Interval 59.7 to 83.6	46.6 percentage of participants Interval 33.3 to 60.1
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination Serogroup C	100 percentage of participants Interval 93.9 to 100.0	93.2 percentage of participants Interval 83.5 to 98.1
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination Serogroup Y	100 percentage of participants Interval 93.9 to 100.0	88.1 percentage of participants Interval 77.1 to 95.1
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination Serogroup W	100 percentage of participants Interval 93.9 to 100.0	76.3 percentage of participants Interval 63.4 to 86.4

SECONDARY outcome

Timeframe: At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra

Outcome measures

Outcome measures
Measure	Infants: Group 1 n=59 Participants Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=59 Participants Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra Serogroup A	72.9 percentage of participants Interval 59.7 to 83.6	46.6 percentage of participants Interval 33.3 to 60.1
Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra Serogroup C	100 percentage of participants Interval 93.9 to 100.0	93.2 percentage of participants Interval 83.5 to 98.1
Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra Serogroup Y	100 percentage of participants Interval 93.9 to 100.0	88.1 percentage of participants Interval 77.1 to 95.1
Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra Serogroup W	100 percentage of participants Interval 93.9 to 100.0	76.3 percentage of participants Interval 63.4 to 86.4

Adverse Events

Infants: Group 1

Serious events: 6 serious events

Other events: 288 other events

Deaths: 0 deaths

Infants: Group 2

Serious events: 12 serious events

Other events: 257 other events

Deaths: 0 deaths

Toddlers: Group 3

Serious events: 1 serious events

Other events: 68 other events

Deaths: 0 deaths

Toddlers: Group 4

Serious events: 4 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Trial Transparency Team

Sanofi Pasteur

Phone: 800-633-1610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Publication restrictions are in place

Restriction type: OTHER

Measure	Infants: Group 1 n=370 participants at risk Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Infants: Group 2 n=361 participants at risk Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	Toddlers: Group 3 n=96 participants at risk Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.	Toddlers: Group 4 n=103 participants at risk Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.
Nervous system disorders Somnolence	43.2% 160/370 • Number of events 208 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	43.5% 157/361 • Number of events 218 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	29.2% 28/96 • Number of events 41 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	29.1% 30/103 • Number of events 36 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
Gastrointestinal disorders Teething	7.8% 29/370 • Number of events 44 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	6.9% 25/361 • Number of events 42 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	1.0% 1/96 • Number of events 1 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	2.9% 3/103 • Number of events 3 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
Gastrointestinal disorders Vomiting	11.9% 44/370 • Number of events 50 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	10.8% 39/361 • Number of events 41 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	8.3% 8/96 • Number of events 9 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	9.7% 10/103 • Number of events 10 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
Metabolism and nutrition disorders Decreased Appetite	22.4% 83/370 • Number of events 104 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	23.0% 83/361 • Number of events 102 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	29.2% 28/96 • Number of events 36 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	33.0% 34/103 • Number of events 47 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
Infections and infestations Influenza	0.27% 1/370 • Number of events 1 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	0.00% 0/361 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	5.2% 5/96 • Number of events 5 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	0.97% 1/103 • Number of events 1 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
Infections and infestations Nasopharyngitis	5.4% 20/370 • Number of events 22 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	3.0% 11/361 • Number of events 16 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	1.0% 1/96 • Number of events 1 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	0.00% 0/103 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
Infections and infestations Otitis Media	4.1% 15/370 • Number of events 17 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	3.9% 14/361 • Number of events 17 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	5.2% 5/96 • Number of events 5 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	4.9% 5/103 • Number of events 5 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
Infections and infestations Upper Respiratory Tract Infection	11.1% 41/370 • Number of events 45 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	11.1% 40/361 • Number of events 44 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	3.1% 3/96 • Number of events 4 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	3.9% 4/103 • Number of events 4 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
General disorders Crying	43.2% 160/370 • Number of events 200 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	38.2% 138/361 • Number of events 179 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	36.5% 35/96 • Number of events 45 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	33.0% 34/103 • Number of events 45 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
General disorders Injection Site Bruising	5.1% 19/370 • Number of events 35 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	3.6% 13/361 • Number of events 17 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	3.1% 3/96 • Number of events 3 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	2.9% 3/103 • Number of events 4 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
General disorders Injection Site Erythema	40.8% 151/370 • Number of events 479 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	38.2% 138/361 • Number of events 460 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	30.2% 29/96 • Number of events 41 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	25.2% 26/103 • Number of events 37 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
General disorders Injection Site Pain	54.6% 202/370 • Number of events 782 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	49.9% 180/361 • Number of events 691 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	44.8% 43/96 • Number of events 65 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	39.8% 41/103 • Number of events 60 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
General disorders Injection Site Swelling	33.8% 125/370 • Number of events 361 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	29.1% 105/361 • Number of events 331 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	24.0% 23/96 • Number of events 34 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	13.6% 14/103 • Number of events 19 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
General disorders Pyrexia	18.4% 68/370 • Number of events 83 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	19.7% 71/361 • Number of events 81 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	18.8% 18/96 • Number of events 28 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	19.4% 20/103 • Number of events 23 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
Psychiatric disorders Irritability	54.6% 202/370 • Number of events 289 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	51.5% 186/361 • Number of events 264 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	45.8% 44/96 • Number of events 65 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	50.5% 52/103 • Number of events 74 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.
Respiratory, thoracic and mediastinal disorders Cough	3.0% 11/370 • Number of events 11 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	1.7% 6/361 • Number of events 8 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	6.2% 6/96 • Number of events 7 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.	0.97% 1/103 • Number of events 1 • From the first study vaccine administration (Day 0) up to 6 months after the last vaccination; mean study subject duration was 337 days for groups 1 and 2, and 283 days for groups 3 and 4 Analysis was performed on the overall safety analysis set for any dose.