Trial Outcomes & Findings for A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants (NCT NCT00474526)

NCT ID: NCT00474526

Last Updated: 2014-03-24

Results Overview

Immunogenicity as measured by percentage of subjects with hSBA titer \>=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 4545 participants
• Primary outcome timeframe: 13 months of age (one month post-toddler vaccination)
• Results posted on: 2014-03-24

Participant Flow

Participant milestones

Measure	US1A (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.	US1B (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4A (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US4B (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.	US4C (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.	LA1A (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	LA1B (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3A (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.	LA3B (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6A (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.	LA6B (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Overall Study STARTED	154	166	159	680	76	70	203	151	150	148	151	150	150	1426	358	170	183
Overall Study COMPLETED	121	120	110	561	8	54	178	145	144	121	141	139	135	1270	281	152	174
Overall Study NOT COMPLETED	33	46	49	119	68	16	25	6	6	27	10	11	15	156	77	18	9

Reasons for withdrawal

Measure	US1A (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.	US1B (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4A (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US4B (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.	US4C (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.	LA1A (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	LA1B (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3A (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.	LA3B (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6A (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.	LA6B (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Overall Study ADMINISTRATIVE REASON	11	9	9	20	9	1	1	0	2	1	1	1	1	1	2	0	0
Overall Study Adverse Event	2	0	2	4	2	1	1	0	0	0	0	0	0	0	1	1	0
Overall Study Death	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0
Overall Study INAPPROPRIATE ENROLLMENT	0	1	0	1	2	0	0	0	0	0	0	0	0	2	2	0	0
Overall Study Lost to Follow-up	8	6	13	29	11	5	8	1	0	6	2	4	6	74	29	4	5
Overall Study Protocol Violation	2	6	4	12	3	1	3	0	0	4	2	2	4	19	9	6	2
Overall Study UNABLE TO CLASSIFY	1	0	0	1	3	2	0	1	0	3	0	0	0	20	12	6	1
Overall Study Withdrawal by Subject	9	24	21	52	38	6	12	4	4	13	5	4	4	37	22	1	1

Baseline Characteristics

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

Baseline characteristics by cohort

Measure	US1A (MenACWY-CRM + Infant Vaccines) n=154 Participants US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.	US1B (MenACWY-CRM + Infant Vaccines) n=166 Participants US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.	US2 (Infant Vaccines Only) n=159 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) n=680 Participants US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4A (Infant Vaccines Only) n=76 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US4B (Infant Vaccines Only) n=70 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.	US4C (Infant Vaccines Only) n=203 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.	LA1A (MenACWY-CRM + Infant Vaccines) n=151 Participants LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	LA1B (MenACWY-CRM + Infant Vaccines) n=150 Participants LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.	LA2 (Infant Vaccines Only) n=148 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3A (MenACWY-CRM + Infant Vaccines) n=151 Participants LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.	LA3B (MenACWY-CRM + Infant Vaccines) n=150 Participants LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.	LA4 (Infant Vaccines Only) n=150 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) n=1426 Participants LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6A (Infant Vaccines Only) n=358 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.	LA6B (Infant Vaccines Only) n=170 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.	LA6C (Infant Vaccines Only) n=183 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age	TOTAL n=4545 Participants Total of all reporting groups
Age, Continuous	66.1 days STANDARD_DEVIATION 7.2 • n=5 Participants	65.8 days STANDARD_DEVIATION 6.6 • n=7 Participants	65.7 days STANDARD_DEVIATION 6.5 • n=5 Participants	65.0 days STANDARD_DEVIATION 6.0 • n=4 Participants	66.1 days STANDARD_DEVIATION 6.2 • n=21 Participants	65.0 days STANDARD_DEVIATION 6.5 • n=8 Participants	65.9 days STANDARD_DEVIATION 6.5 • n=8 Participants	68.0 days STANDARD_DEVIATION 7.7 • n=24 Participants	68.6 days STANDARD_DEVIATION 8.9 • n=42 Participants	67.8 days STANDARD_DEVIATION 8.3 • n=42 Participants	67.0 days STANDARD_DEVIATION 7.9 • n=42 Participants	68.4 days STANDARD_DEVIATION 8.7 • n=42 Participants	67.5 days STANDARD_DEVIATION 8.0 • n=36 Participants	65.0 days STANDARD_DEVIATION 9.4 • n=36 Participants	67.7 days STANDARD_DEVIATION 9.7 • n=24 Participants	59.5 days STANDARD_DEVIATION 6.2 • n=135 Participants	65.0 days STANDARD_DEVIATION 7.9 • n=136 Participants	65.7 days STANDARD_DEVIATION 8.3 • n=44 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	72 Participants n=7 Participants	71 Participants n=5 Participants	340 Participants n=4 Participants	39 Participants n=21 Participants	29 Participants n=8 Participants	103 Participants n=8 Participants	79 Participants n=24 Participants	82 Participants n=42 Participants	72 Participants n=42 Participants	72 Participants n=42 Participants	75 Participants n=42 Participants	81 Participants n=36 Participants	682 Participants n=36 Participants	178 Participants n=24 Participants	89 Participants n=135 Participants	91 Participants n=136 Participants	2223 Participants n=44 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	94 Participants n=7 Participants	88 Participants n=5 Participants	340 Participants n=4 Participants	37 Participants n=21 Participants	41 Participants n=8 Participants	100 Participants n=8 Participants	72 Participants n=24 Participants	68 Participants n=42 Participants	76 Participants n=42 Participants	79 Participants n=42 Participants	75 Participants n=42 Participants	69 Participants n=36 Participants	744 Participants n=36 Participants	180 Participants n=24 Participants	81 Participants n=135 Participants	92 Participants n=136 Participants	2322 Participants n=44 Participants

PRIMARY outcome

Timeframe: 13 months of age (one month post-toddler vaccination)

Population: The analysis was done on per protocol population Per protocol was defined as subjects who: * received all the relevant doses of vaccine correctly * provided evaluable serum samples at the relevant time points * had no major protocol deviation as defined prior to database lock

Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=86 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=74 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects A (84, 74)	94 Percentages of subjects Interval 87.0 to 98.0	72 Percentages of subjects Interval 60.0 to 81.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects C (86, 73)	98 Percentages of subjects Interval 92.0 to 100.0	90 Percentages of subjects Interval 81.0 to 96.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects W (85, 73)	100 Percentages of subjects Interval 96.0 to 100.0	58 Percentages of subjects Interval 45.0 to 69.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects Y (84, 68)	100 Percentages of subjects Interval 96.0 to 100.0	56 Percentages of subjects Interval 43.0 to 68.0	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 13 months of age (one month post-toddler vaccination)

Population: The analysis was done on per protocol population

Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=86 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=74 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Geometric Mean hSBA Titers - US Subjects C Pre-vaccination (86, 73)	7.72 Titers Interval 5.9 to 10.0	2.26 Titers Interval 1.69 to 3.03	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers - US Subjects C Post-vaccination (86, 73)	227 Titers Interval 155.0 to 332.0	35 Titers Interval 23.0 to 54.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers - US Subjects W Pre-vaccination (85, 73)	14 Titers Interval 11.0 to 18.0	2.21 Titers Interval 1.69 to 2.9	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers - US Subjects W Post-vaccination (85, 73)	416 Titers Interval 288.0 to 602.0	11 Titers Interval 7.59 to 17.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers - US Subjects Y Pre-vaccination (84, 68)	11 Titers Interval 8.76 to 15.0	2.14 Titers Interval 1.6 to 2.86	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers - US Subjects Y Post-vaccination (84, 68)	395 Titers Interval 269.0 to 580.0	10 Titers Interval 6.72 to 16.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers - US Subjects A Pre-vaccination (84, 74)	2.51 Titers Interval 2.14 to 2.96	2.14 Titers Interval 1.8 to 2.54	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers - US Subjects A Post-vaccination (84, 74)	77 Titers Interval 55.0 to 109.0	17 Titers Interval 12.0 to 25.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 days after vaccination

Population: The population used in analysis was the safety set Safety population was defined as: all subjects in the exposed population who provided post-baseline safety data. If a subject received an entirely wrong vaccine schedule (e.g., US3 instead of US4), the subject would be analyzed for safety according to the group the subject actually followed.

Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=153 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=165 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=318 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=159 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) n=677 Participants US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) n=345 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) n=301 Participants LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) n=148 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) n=301 Participants LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) n=150 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) n=1424 Participants LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) n=709 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Irritability - Severe	6 Subjects	2 Subjects	8 Subjects	4 Subjects	24 Subjects	12 Subjects	7 Subjects	2 Subjects	4 Subjects	2 Subjects	22 Subjects	2 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Persistent Crying - Any	43 Subjects	74 Subjects	117 Subjects	49 Subjects	252 Subjects	125 Subjects	95 Subjects	53 Subjects	87 Subjects	43 Subjects	479 Subjects	258 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Persistent Crying - Severe	1 Subjects	2 Subjects	3 Subjects	5 Subjects	11 Subjects	8 Subjects	5 Subjects	3 Subjects	11 Subjects	8 Subjects	29 Subjects	21 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Rash - Any	6 Subjects	9 Subjects	15 Subjects	5 Subjects	16 Subjects	11 Subjects	11 Subjects	6 Subjects	12 Subjects	4 Subjects	98 Subjects	55 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Rash - Severe	3 Subjects	4 Subjects	7 Subjects	3 Subjects	4 Subjects	3 Subjects	7 Subjects	2 Subjects	4 Subjects	1 Subjects	54 Subjects	26 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Sleepiness - Any	83 Subjects	104 Subjects	187 Subjects	76 Subjects	354 Subjects	173 Subjects	106 Subjects	53 Subjects	93 Subjects	52 Subjects	727 Subjects	381 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Sleepiness - Severe	2 Subjects	3 Subjects	5 Subjects	0 Subjects	14 Subjects	3 Subjects	8 Subjects	2 Subjects	6 Subjects	4 Subjects	21 Subjects	14 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Vomiting - Any	15 Subjects	18 Subjects	33 Subjects	14 Subjects	67 Subjects	36 Subjects	25 Subjects	9 Subjects	29 Subjects	17 Subjects	215 Subjects	100 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Vomiting - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects	2 Subjects	1 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Erythema (mm) - Severe	0 Subjects	0 Subjects	0 Subjects	2 Subjects	0 Subjects	4 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects	1 Subjects	4 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Induration (mm) - Any	10 Subjects	14 Subjects	24 Subjects	25 Subjects	61 Subjects	44 Subjects	74 Subjects	56 Subjects	72 Subjects	53 Subjects	249 Subjects	126 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Induration (mm) - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects	0 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Change in Eating Habits - Severe	1 Subjects	1 Subjects	2 Subjects	1 Subjects	8 Subjects	2 Subjects	2 Subjects	0 Subjects	0 Subjects	1 Subjects	6 Subjects	4 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Diarrhea - Any	24 Subjects	23 Subjects	47 Subjects	17 Subjects	107 Subjects	46 Subjects	42 Subjects	20 Subjects	44 Subjects	22 Subjects	222 Subjects	96 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Diarrhea - Severe	2 Subjects	0 Subjects	2 Subjects	1 Subjects	3 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects	2 Subjects	2 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Irritability - Any	82 Subjects	107 Subjects	189 Subjects	96 Subjects	419 Subjects	211 Subjects	121 Subjects	62 Subjects	99 Subjects	59 Subjects	508 Subjects	240 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Tenderness - Any	64 Subjects	76 Subjects	140 Subjects	69 Subjects	324 Subjects	161 Subjects	154 Subjects	96 Subjects	170 Subjects	95 Subjects	916 Subjects	501 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Tenderness - Severe	3 Subjects	4 Subjects	7 Subjects	6 Subjects	25 Subjects	19 Subjects	30 Subjects	19 Subjects	22 Subjects	20 Subjects	92 Subjects	74 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Body Temp. ( >= 38° C )	13 Subjects	6 Subjects	19 Subjects	7 Subjects	32 Subjects	21 Subjects	15 Subjects	12 Subjects	18 Subjects	5 Subjects	211 Subjects	97 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Change in Eating Habits - Any	42 Subjects	46 Subjects	88 Subjects	34 Subjects	171 Subjects	96 Subjects	37 Subjects	30 Subjects	44 Subjects	16 Subjects	250 Subjects	127 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Erythema (mm) - Any	10 Subjects	17 Subjects	27 Subjects	23 Subjects	66 Subjects	54 Subjects	86 Subjects	62 Subjects	86 Subjects	65 Subjects	542 Subjects	273 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Analgesic / Antipyretic medication used	105 Subjects	120 Subjects	225 Subjects	110 Subjects	447 Subjects	223 Subjects	155 Subjects	75 Subjects	159 Subjects	80 Subjects	996 Subjects	510 Subjects	—

SECONDARY outcome

Timeframe: 7 days after vaccination

Population: The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. LA1 and LA 2 groups are not included here as they did not receive MenACWY at 4 months of age.

Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=141 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=150 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=291 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=151 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) n=645 Participants US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) n=325 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) n=301 Participants LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) n=150 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) n=1424 Participants LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) n=709 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Sleepiness - Severe	0 Subjects	0 Subjects	0 Subjects	1 Subjects	3 Subjects	2 Subjects	4 Subjects	1 Subjects	13 Subjects	7 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Vomiting - Any	8 Subjects	9 Subjects	17 Subjects	7 Subjects	49 Subjects	27 Subjects	20 Subjects	10 Subjects	136 Subjects	75 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Irritability - Any	83 Subjects	80 Subjects	163 Subjects	83 Subjects	342 Subjects	182 Subjects	82 Subjects	41 Subjects	414 Subjects	209 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Irritability - Severe	2 Subjects	0 Subjects	2 Subjects	3 Subjects	14 Subjects	9 Subjects	3 Subjects	0 Subjects	13 Subjects	5 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Persistent Crying - Any	42 Subjects	41 Subjects	83 Subjects	34 Subjects	178 Subjects	107 Subjects	42 Subjects	22 Subjects	294 Subjects	187 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Persistent Crying - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	5 Subjects	4 Subjects	4 Subjects	1 Subjects	14 Subjects	10 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Erythema (mm) - Any	14 Subjects	19 Subjects	33 Subjects	35 Subjects	75 Subjects	60 Subjects	92 Subjects	45 Subjects	583 Subjects	311 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Erythema (mm) - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Induration (mm) - Any	16 Subjects	16 Subjects	32 Subjects	27 Subjects	45 Subjects	48 Subjects	73 Subjects	36 Subjects	194 Subjects	126 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Induration (mm) - Severe	1 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	3 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Tenderness - Any	59 Subjects	59 Subjects	118 Subjects	56 Subjects	230 Subjects	137 Subjects	115 Subjects	59 Subjects	726 Subjects	401 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Tenderness - Severe	1 Subjects	0 Subjects	1 Subjects	2 Subjects	13 Subjects	11 Subjects	13 Subjects	5 Subjects	49 Subjects	45 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Body Temp. ( >= 38° C )	17 Subjects	6 Subjects	23 Subjects	15 Subjects	49 Subjects	28 Subjects	23 Subjects	13 Subjects	223 Subjects	122 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Change in Eating Habits - Any	25 Subjects	21 Subjects	46 Subjects	20 Subjects	122 Subjects	64 Subjects	28 Subjects	12 Subjects	160 Subjects	90 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Change in Eating Habits - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	3 Subjects	0 Subjects	3 Subjects	0 Subjects	6 Subjects	5 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Diarrhea - Any	16 Subjects	10 Subjects	26 Subjects	11 Subjects	53 Subjects	35 Subjects	28 Subjects	14 Subjects	149 Subjects	90 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Diarrhea - Severe	0 Subjects	1 Subjects	1 Subjects	1 Subjects	1 Subjects	2 Subjects	1 Subjects	0 Subjects	4 Subjects	1 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Rash - Any	3 Subjects	5 Subjects	8 Subjects	4 Subjects	24 Subjects	13 Subjects	13 Subjects	2 Subjects	97 Subjects	46 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Rash - Severe	3 Subjects	1 Subjects	4 Subjects	1 Subjects	6 Subjects	4 Subjects	5 Subjects	1 Subjects	52 Subjects	29 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Sleepiness - Any	69 Subjects	56 Subjects	125 Subjects	47 Subjects	238 Subjects	131 Subjects	62 Subjects	26 Subjects	485 Subjects	237 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Vomiting - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	3 Subjects	0 Subjects	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Analgesic / Antipyretic medication used	94 Subjects	91 Subjects	185 Subjects	96 Subjects	385 Subjects	201 Subjects	131 Subjects	61 Subjects	857 Subjects	430 Subjects	—	—	—

SECONDARY outcome

Timeframe: 7 days after vaccination

Population: The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.

Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=138 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=145 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=283 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=143 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) n=627 Participants US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) n=311 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) n=297 Participants LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) n=131 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) n=290 Participants LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) n=147 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) n=1357 Participants LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) n=679 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Persistent Crying - Any	28 Subjects	26 Subjects	54 Subjects	24 Subjects	135 Subjects	74 Subjects	28 Subjects	15 Subjects	27 Subjects	12 Subjects	181 Subjects	118 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Erythema (mm) - Any	16 Subjects	18 Subjects	34 Subjects	28 Subjects	92 Subjects	67 Subjects	69 Subjects	27 Subjects	64 Subjects	38 Subjects	485 Subjects	273 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Persistent Crying - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	4 Subjects	4 Subjects	2 Subjects	2 Subjects	0 Subjects	0 Subjects	11 Subjects	2 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Erythema (mm) - Severe	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Induration (mm) - Any	15 Subjects	15 Subjects	30 Subjects	29 Subjects	59 Subjects	53 Subjects	54 Subjects	25 Subjects	64 Subjects	32 Subjects	125 Subjects	73 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Rash - Any	2 Subjects	9 Subjects	11 Subjects	4 Subjects	14 Subjects	8 Subjects	8 Subjects	1 Subjects	6 Subjects	1 Subjects	62 Subjects	29 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Induration (mm) - Severe	0 Subjects	0 Subjects	0 Subjects	2 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Rash - Severe	1 Subjects	4 Subjects	5 Subjects	3 Subjects	2 Subjects	1 Subjects	5 Subjects	0 Subjects	3 Subjects	1 Subjects	29 Subjects	10 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Tenderness - Any	37 Subjects	45 Subjects	82 Subjects	45 Subjects	189 Subjects	92 Subjects	92 Subjects	40 Subjects	78 Subjects	50 Subjects	504 Subjects	306 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Sleepiness - Any	37 Subjects	41 Subjects	78 Subjects	39 Subjects	179 Subjects	91 Subjects	38 Subjects	15 Subjects	45 Subjects	17 Subjects	317 Subjects	164 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Tenderness - Severe	0 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects	7 Subjects	6 Subjects	2 Subjects	2 Subjects	1 Subjects	21 Subjects	14 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Sleepiness - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	6 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects	6 Subjects	3 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Body Temp. ( >= 38° C )	4 Subjects	9 Subjects	13 Subjects	14 Subjects	33 Subjects	20 Subjects	13 Subjects	10 Subjects	26 Subjects	14 Subjects	164 Subjects	101 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Vomiting - Any	6 Subjects	6 Subjects	12 Subjects	9 Subjects	31 Subjects	20 Subjects	16 Subjects	9 Subjects	11 Subjects	12 Subjects	104 Subjects	52 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Vomiting - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	2 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Analgesic / Antipyretic medication used	75 Subjects	82 Subjects	157 Subjects	96 Subjects	349 Subjects	178 Subjects	93 Subjects	38 Subjects	90 Subjects	51 Subjects	592 Subjects	342 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Change in Eating Habits - Any	19 Subjects	22 Subjects	41 Subjects	18 Subjects	94 Subjects	39 Subjects	25 Subjects	11 Subjects	23 Subjects	9 Subjects	126 Subjects	66 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Change in Eating Habits - Severe	0 Subjects	0 Subjects	0 Subjects	1 Subjects	3 Subjects	2 Subjects	1 Subjects	1 Subjects	1 Subjects	0 Subjects	5 Subjects	3 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Diarrhea - Any	13 Subjects	9 Subjects	22 Subjects	9 Subjects	41 Subjects	26 Subjects	17 Subjects	8 Subjects	12 Subjects	11 Subjects	97 Subjects	58 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Diarrhea - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects	1 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	2 Subjects	3 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Irritability - Any	58 Subjects	73 Subjects	131 Subjects	70 Subjects	285 Subjects	157 Subjects	57 Subjects	29 Subjects	62 Subjects	28 Subjects	311 Subjects	164 Subjects	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Irritability - Severe	1 Subjects	1 Subjects	2 Subjects	0 Subjects	4 Subjects	6 Subjects	0 Subjects	1 Subjects	2 Subjects	0 Subjects	5 Subjects	2 Subjects	—

SECONDARY outcome

Timeframe: 7 days after vaccination

Population: The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.

Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=122 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=124 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=704 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=137 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) n=582 Participants US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) n=261 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) n=145 Participants LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) n=143 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) n=564 Participants LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) n=1275 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) n=349 Participants LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Erythema (mm) - Any	11 Subjects	16 Subjects	81 Subjects	18 Subjects	70 Subjects	49 Subjects	36 Subjects	33 Subjects	166 Subjects	309 Subjects	67 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Erythema (mm) - Severe	0 Subjects	0 Subjects	2 Subjects	1 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects	2 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Induration (mm) - Any	10 Subjects	13 Subjects	44 Subjects	12 Subjects	34 Subjects	39 Subjects	32 Subjects	28 Subjects	72 Subjects	84 Subjects	43 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Induration (mm) - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Tenderness - Any	28 Subjects	31 Subjects	177 Subjects	38 Subjects	149 Subjects	75 Subjects	35 Subjects	32 Subjects	184 Subjects	392 Subjects	100 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Tenderness - Severe	0 Subjects	0 Subjects	2 Subjects	0 Subjects	2 Subjects	1 Subjects	6 Subjects	2 Subjects	2 Subjects	8 Subjects	3 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Body Temp. ( >= 38° C )	14 Subjects	10 Subjects	49 Subjects	12 Subjects	35 Subjects	20 Subjects	16 Subjects	12 Subjects	84 Subjects	188 Subjects	40 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Change in Eating Habits - Any	21 Subjects	17 Subjects	101 Subjects	20 Subjects	80 Subjects	29 Subjects	10 Subjects	11 Subjects	56 Subjects	138 Subjects	46 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Change in Eating Habits - Severe	1 Subjects	2 Subjects	7 Subjects	1 Subjects	6 Subjects	1 Subjects	1 Subjects	0 Subjects	4 Subjects	5 Subjects	0 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Diarrhea - Any	5 Subjects	14 Subjects	61 Subjects	16 Subjects	56 Subjects	14 Subjects	9 Subjects	10 Subjects	51 Subjects	123 Subjects	37 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Diarrhea - Severe	0 Subjects	0 Subjects	4 Subjects	1 Subjects	4 Subjects	1 Subjects	0 Subjects	0 Subjects	5 Subjects	7 Subjects	1 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Irritability - Any	53 Subjects	53 Subjects	271 Subjects	62 Subjects	218 Subjects	103 Subjects	29 Subjects	23 Subjects	130 Subjects	289 Subjects	74 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Irritability - Severe	2 Subjects	2 Subjects	8 Subjects	4 Subjects	6 Subjects	1 Subjects	1 Subjects	2 Subjects	5 Subjects	3 Subjects	0 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Persistent Crying - Any	21 Subjects	21 Subjects	120 Subjects	24 Subjects	99 Subjects	55 Subjects	7 Subjects	12 Subjects	52 Subjects	134 Subjects	28 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Persistent Crying - Severe	0 Subjects	0 Subjects	6 Subjects	1 Subjects	6 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects	2 Subjects	0 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Rash - Any	8 Subjects	4 Subjects	31 Subjects	5 Subjects	23 Subjects	12 Subjects	3 Subjects	1 Subjects	20 Subjects	65 Subjects	17 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Rash - Severe	1 Subjects	1 Subjects	3 Subjects	3 Subjects	2 Subjects	3 Subjects	2 Subjects	0 Subjects	8 Subjects	36 Subjects	10 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Sleepiness - Any	38 Subjects	29 Subjects	149 Subjects	22 Subjects	111 Subjects	50 Subjects	18 Subjects	15 Subjects	81 Subjects	211 Subjects	53 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Sleepiness - Severe	0 Subjects	1 Subjects	3 Subjects	1 Subjects	3 Subjects	3 Subjects	0 Subjects	0 Subjects	1 Subjects	3 Subjects	2 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Vomiting - Any	6 Subjects	4 Subjects	27 Subjects	8 Subjects	21 Subjects	11 Subjects	3 Subjects	5 Subjects	35 Subjects	82 Subjects	12 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Vomiting - Severe	0 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	3 Subjects	4 Subjects	0 Subjects	—	—
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age Analgesic / Antipyretic medication used	60 Subjects	56 Subjects	320 Subjects	78 Subjects	260 Subjects	120 Subjects	48 Subjects	43 Subjects	204 Subjects	406 Subjects	87 Subjects	—	—

SECONDARY outcome

Timeframe: 7 days post vaccination

Population: The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.

Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=120 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=704 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=136 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=59 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) n=179 Participants US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) n=145 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) n=143 Participants LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) n=564 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) n=142 Participants LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) n=137 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) n=1275 Participants LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) n=160 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) n=175 Participants LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Erythema (mm) - Any	7 Subjects	81 Subjects	18 Subjects	9 Subjects	28 Subjects	36 Subjects	17 Subjects	166 Subjects	36 Subjects	19 Subjects	309 Subjects	24 Subjects	52 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Erythema (mm) - Severe	0 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	2 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	7 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Induration (mm) - Any	1 Subjects	44 Subjects	12 Subjects	3 Subjects	14 Subjects	32 Subjects	9 Subjects	72 Subjects	33 Subjects	16 Subjects	84 Subjects	5 Subjects	35 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Induration (mm) - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	5 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Tenderness - Any	16 Subjects	177 Subjects	38 Subjects	10 Subjects	38 Subjects	35 Subjects	21 Subjects	184 Subjects	36 Subjects	18 Subjects	392 Subjects	34 Subjects	45 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Tenderness - Severe	0 Subjects	2 Subjects	0 Subjects	1 Subjects	1 Subjects	6 Subjects	1 Subjects	2 Subjects	2 Subjects	2 Subjects	8 Subjects	0 Subjects	5 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Body Temp. ( >= 38° C )	5 Subjects	49 Subjects	12 Subjects	0 Subjects	5 Subjects	16 Subjects	5 Subjects	84 Subjects	4 Subjects	2 Subjects	188 Subjects	7 Subjects	8 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Change in Eating Habits - Any	9 Subjects	101 Subjects	20 Subjects	5 Subjects	14 Subjects	10 Subjects	4 Subjects	56 Subjects	6 Subjects	6 Subjects	138 Subjects	9 Subjects	17 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Change in Eating Habits - Severe	0 Subjects	7 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects	1 Subjects	4 Subjects	1 Subjects	0 Subjects	5 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Diarrhea - Any	8 Subjects	61 Subjects	16 Subjects	5 Subjects	13 Subjects	9 Subjects	4 Subjects	51 Subjects	8 Subjects	2 Subjects	123 Subjects	6 Subjects	12 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Diarrhea - Severe	0 Subjects	4 Subjects	1 Subjects	2 Subjects	1 Subjects	0 Subjects	0 Subjects	5 Subjects	0 Subjects	1 Subjects	7 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Irritability - Any	39 Subjects	271 Subjects	62 Subjects	17 Subjects	52 Subjects	29 Subjects	10 Subjects	130 Subjects	13 Subjects	9 Subjects	289 Subjects	25 Subjects	28 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Irritability - Severe	1 Subjects	8 Subjects	4 Subjects	1 Subjects	1 Subjects	1 Subjects	0 Subjects	5 Subjects	0 Subjects	0 Subjects	3 Subjects	1 Subjects	0 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Persistent Crying - Any	16 Subjects	120 Subjects	24 Subjects	10 Subjects	17 Subjects	7 Subjects	5 Subjects	52 Subjects	4 Subjects	5 Subjects	134 Subjects	9 Subjects	15 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Persistent Crying - Severe	0 Subjects	6 Subjects	1 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects	1 Subjects	0 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Rash - Any	1 Subjects	31 Subjects	5 Subjects	2 Subjects	5 Subjects	3 Subjects	1 Subjects	20 Subjects	2 Subjects	1 Subjects	65 Subjects	2 Subjects	2 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Rash - Severe	0 Subjects	3 Subjects	3 Subjects	0 Subjects	2 Subjects	2 Subjects	1 Subjects	8 Subjects	2 Subjects	0 Subjects	36 Subjects	0 Subjects	1 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Sleepiness - Any	25 Subjects	149 Subjects	22 Subjects	6 Subjects	21 Subjects	18 Subjects	3 Subjects	81 Subjects	6 Subjects	7 Subjects	211 Subjects	14 Subjects	20 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Sleepiness - Severe	1 Subjects	3 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	3 Subjects	1 Subjects	1 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Vomiting - Any	2 Subjects	27 Subjects	8 Subjects	2 Subjects	6 Subjects	3 Subjects	0 Subjects	35 Subjects	1 Subjects	3 Subjects	82 Subjects	4 Subjects	3 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Vomiting - Severe	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	3 Subjects	0 Subjects	0 Subjects	4 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series Analgesic / Antipyretic medication used	37 Subjects	320 Subjects	77 Subjects	16 Subjects	45 Subjects	48 Subjects	15 Subjects	204 Subjects	20 Subjects	8 Subjects	406 Subjects	14 Subjects	34 Subjects

SECONDARY outcome

Timeframe: 7 days post vaccination

Population: The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose at 15 months were included in this analysis.

Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=120 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=55 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=539 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=153 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Vomiting - Severe	0 Subjects	0 Subjects	0 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Analgesic / Antipyretic medication used	40 Subjects	14 Subjects	85 Subjects	21 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Sleepiness - Any	12 Subjects	8 Subjects	36 Subjects	12 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Erythema (mm) - Any	14 Subjects	6 Subjects	143 Subjects	28 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Erythema (mm) - Severe	0 Subjects	1 Subjects	2 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Induration (mm) - Any	10 Subjects	2 Subjects	51 Subjects	2 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Induration (mm) - Severe	0 Subjects	1 Subjects	1 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Tenderness - Any	19 Subjects	16 Subjects	128 Subjects	33 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Tenderness - Severe	0 Subjects	0 Subjects	5 Subjects	1 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Body Temp. ( >= 38° C )	5 Subjects	1 Subjects	30 Subjects	15 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Change in Eating Habits - Any	7 Subjects	2 Subjects	18 Subjects	11 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Change in Eating Habits - Severe	0 Subjects	0 Subjects	0 Subjects	1 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Diarrhea - Any	4 Subjects	3 Subjects	28 Subjects	9 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Diarrhea - Severe	1 Subjects	0 Subjects	1 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Irritability - Any	31 Subjects	22 Subjects	71 Subjects	32 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Irritability - Severe	0 Subjects	0 Subjects	2 Subjects	1 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Persistent Crying - Any	9 Subjects	10 Subjects	37 Subjects	6 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Persistent Crying - Severe	0 Subjects	0 Subjects	3 Subjects	2 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Rash - Any	4 Subjects	1 Subjects	9 Subjects	3 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Rash - Severe	0 Subjects	0 Subjects	4 Subjects	3 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Sleepiness - Severe	0 Subjects	0 Subjects	1 Subjects	2 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series Vomiting - Any	5 Subjects	2 Subjects	12 Subjects	7 Subjects	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 days post-vaccination

Population: The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.

Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=989 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=503 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=1724 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=859 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Induration (mm) - Any	85 Subjects	69 Subjects	321 Subjects	179 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Induration (mm) - Severe	0 Subjects	1 Subjects	2 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Tenderness - Any	464 Subjects	230 Subjects	1086 Subjects	596 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Tenderness - Severe	32 Subjects	25 Subjects	114 Subjects	94 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Body Temp. ( >= 38° C )	51 Subjects	28 Subjects	229 Subjects	102 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Erythema (mm) - Any	93 Subjects	77 Subjects	628 Subjects	338 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Erythema (mm) - Severe	0 Subjects	6 Subjects	2 Subjects	5 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Change in Eating Habits - Any	259 Subjects	130 Subjects	294 Subjects	143 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Change in Eating Habits - Severe	10 Subjects	3 Subjects	6 Subjects	5 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Diarrhea - Any	154 Subjects	63 Subjects	266 Subjects	118 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Diarrhea - Severe	5 Subjects	2 Subjects	3 Subjects	2 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Irritability - Any	608 Subjects	307 Subjects	607 Subjects	299 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Irritability - Severe	32 Subjects	16 Subjects	26 Subjects	4 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Persistent Crying - Any	369 Subjects	174 Subjects	566 Subjects	301 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Persistent Crying - Severe	14 Subjects	13 Subjects	40 Subjects	29 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Rash - Any	31 Subjects	16 Subjects	110 Subjects	59 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Rash - Severe	11 Subjects	6 Subjects	58 Subjects	27 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Sleepiness - Any	541 Subjects	249 Subjects	820 Subjects	433 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Sleepiness - Severe	19 Subjects	3 Subjects	27 Subjects	18 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Vomiting - Any	100 Subjects	50 Subjects	244 Subjects	117 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Vomiting - Severe	0 Subjects	1 Subjects	3 Subjects	2 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series Analgesic / Antipyretic medication used	672 Subjects	333 Subjects	1155 Subjects	590 Subjects	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 days post-vaccination

Population: The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose of the infant series vaccination were included in the analysis.

Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=936 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=476 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=1672 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=824 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Vomiting - Severe	0 Subjects	1 Subjects	4 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Induration (mm) - Severe	1 Subjects	3 Subjects	0 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Tenderness - Any	348 Subjects	193 Subjects	841 Subjects	460 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Tenderness - Severe	14 Subjects	13 Subjects	62 Subjects	50 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Body Temp. ( >= 38° C )	72 Subjects	43 Subjects	246 Subjects	135 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Change in Eating Habits - Any	168 Subjects	84 Subjects	188 Subjects	102 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Change in Eating Habits - Severe	3 Subjects	0 Subjects	9 Subjects	5 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Diarrhea - Any	79 Subjects	46 Subjects	177 Subjects	104 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Diarrhea - Severe	2 Subjects	3 Subjects	5 Subjects	1 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Irritability - Any	505 Subjects	265 Subjects	496 Subjects	250 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Irritability - Severe	16 Subjects	12 Subjects	16 Subjects	5 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Persistent Crying - Any	261 Subjects	141 Subjects	336 Subjects	209 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Persistent Crying - Severe	5 Subjects	4 Subjects	18 Subjects	11 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Rash - Any	32 Subjects	17 Subjects	110 Subjects	48 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Rash - Severe	10 Subjects	5 Subjects	57 Subjects	30 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Sleepiness - Any	363 Subjects	178 Subjects	547 Subjects	263 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Sleepiness - Severe	3 Subjects	3 Subjects	17 Subjects	8 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Vomiting - Any	66 Subjects	34 Subjects	156 Subjects	85 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Analgesic / Antipyretic medication used	570 Subjects	297 Subjects	988 Subjects	491 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Erythema (mm) - Any	108 Subjects	95 Subjects	675 Subjects	356 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Erythema (mm) - Severe	0 Subjects	2 Subjects	0 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series Induration (mm) - Any	77 Subjects	75 Subjects	267 Subjects	162 Subjects	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 days post-vaccination

Population: The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the third dose in the infant series were included in this analysis.

Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=910 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=454 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=1646 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=826 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Erythema (mm) - Any	126 Subjects	95 Subjects	549 Subjects	311 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Erythema (mm) - Severe	0 Subjects	2 Subjects	2 Subjects	1 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Induration (mm) - Any	89 Subjects	82 Subjects	189 Subjects	105 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Induration (mm) - Severe	0 Subjects	3 Subjects	1 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Tenderness - Any	271 Subjects	137 Subjects	582 Subjects	356 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Tenderness - Severe	1 Subjects	8 Subjects	23 Subjects	15 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Body Temp. ( >= 38° C )	46 Subjects	34 Subjects	190 Subjects	115 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Change in Eating Habits - Any	135 Subjects	57 Subjects	149 Subjects	75 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Change in Eating Habits - Severe	3 Subjects	3 Subjects	6 Subjects	3 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Diarrhea - Any	63 Subjects	35 Subjects	109 Subjects	69 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Diarrhea - Severe	2 Subjects	1 Subjects	2 Subjects	3 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Irritability - Any	416 Subjects	227 Subjects	373 Subjects	192 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Irritability - Severe	6 Subjects	6 Subjects	7 Subjects	2 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Persistent Crying - Any	189 Subjects	98 Subjects	208 Subjects	130 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Persistent Crying - Severe	4 Subjects	4 Subjects	11 Subjects	2 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Rash - Any	25 Subjects	12 Subjects	68 Subjects	30 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Rash - Severe	7 Subjects	4 Subjects	32 Subjects	11 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Sleepiness - Any	257 Subjects	130 Subjects	362 Subjects	181 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Sleepiness - Severe	6 Subjects	1 Subjects	7 Subjects	3 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Vomiting - Any	43 Subjects	29 Subjects	115 Subjects	64 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Vomiting - Severe	0 Subjects	1 Subjects	2 Subjects	1 Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series Analgesic / Antipyretic medication used	506 Subjects	274 Subjects	682 Subjects	393 Subjects	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 months of age (one month post-infant series)

Population: The analysis was done on per protocol population

Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=212 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=90 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Geometric Mean hSBA Titers Post-infant Series - US Subjects A (Pre-vaccination GMT; N= 177, 65)	2.11 Titers Interval 2.0 to 2.23	2.1 Titers Interval 1.92 to 2.29	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - US Subjects A (Post-vaccination GMT; N= 212, 80)	13 Titers Interval 11.0 to 16.0	2.03 Titers Interval 1.53 to 2.7	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - US Subjects C (Pre-vaccination GMT; N= 168, 64)	2.48 Titers Interval 2.23 to 2.75	2.17 Titers Interval 1.83 to 2.57	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - US Subjects C (Post-vaccination GMT; N= 204, 84)	108 Titers Interval 92.0 to 127.0	2.12 Titers Interval 1.64 to 2.74	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - US Subjects W (Pre-vaccination GMT; N= 165, 66)	3.07 Titers Interval 2.7 to 3.5	2.71 Titers Interval 2.2 to 3.33	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - US Subjects W (Post-vaccination GMT; N=197, 90)	100 Titers Interval 86.0 to 116.0	2.08 Titers Interval 1.67 to 2.6	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - US Subjects Y (Pre-vaccination GMT; N=150, 62 )	2.53 Titers Interval 2.31 to 2.77	2.13 Titers Interval 1.85 to 2.45	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - US Subjects Y (Post-vaccination GMT; N=182, 84)	73 Titers Interval 62.0 to 86.0	2.03 Titers Interval 1.6 to 2.57	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 months of age (one month post-infant series)

Population: Per protocol population

Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=277 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=272 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Geometric Mean hSBA Titers Post-infant Series - LA Subjects A (Pre-vaccination GMT; N= 272, 271)	2.09 Titer Interval 2.03 to 2.16	2.03 Titer Interval 1.97 to 2.09	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - LA Subjects A (Post-vaccination GMT; N= 277, 268)	31 Titer Interval 26.0 to 38.0	43 Titer Interval 36.0 to 52.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - LA Subjects C (Pre-vaccination GMT; N= 273,272)	2.32 Titer Interval 2.18 to 2.47	2.34 Titer Interval 2.19 to 2.49	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - LA Subjects C (Post-vaccination GMT; N= 277, 272)	155 Titer Interval 131.0 to 183.0	150 Titer Interval 127.0 to 177.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - LA Subjects W (Pre-vaccination GMT; N= 263, 261)	2.9 Titer Interval 2.64 to 3.18	2.54 Titer Interval 2.31 to 2.79	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - LA Subjects W (Post-vaccination GMT; N=271,264)	259 Titer Interval 227.0 to 296.0	182 Titer Interval 159.0 to 208.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - LA Subjects Y (Pre-vaccination GMT; N=258, 260)	2.35 Titer Interval 2.22 to 2.49	2.26 Titer Interval 2.14 to 2.39	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers Post-infant Series - LA Subjects Y (Post-vaccination GMT; N=272,263)	159 Titer Interval 136.0 to 185.0	125 Titer Interval 107.0 to 146.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 months of age (one month post-infant series)

Population: Per Protocol Population

Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=212 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=90 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects A (Pre-vaccination GMT; N= 177, 65)	2 Percentages of subjects Interval 0.0 to 5.0	3 Percentages of subjects Interval 0.0 to 11.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects A (Post-vaccination GMT; N= 212, 80)	67 Percentages of subjects Interval 61.0 to 74.0	1 Percentages of subjects Interval 0.032 to 7.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects C (Pre-vaccination GMT; N= 168, 64)	7 Percentages of subjects Interval 3.0 to 11.0	5 Percentages of subjects Interval 1.0 to 13.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects C (Post-vaccination GMT; N= 204, 84)	97 Percentages of subjects Interval 93.0 to 99.0	1 Percentages of subjects Interval 0.03 to 6.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects W (Pre-vaccination GMT; N= 165, 66)	17 Percentages of subjects Interval 12.0 to 24.0	11 Percentages of subjects Interval 4.0 to 21.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects W (Post-vaccination GMT; N=197, 90)	96 Percentages of subjects Interval 93.0 to 99.0	2 Percentages of subjects Interval 0.0 to 8.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects Y (Pre-vaccination GMT; N=150, 62 )	5 Percentages of subjects Interval 2.0 to 10.0	3 Percentages of subjects Interval 0.0 to 11.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects Y (Post-vaccination GMT; N=182, 84)	96 Percentages of subjects Interval 92.0 to 98.0	0 Percentages of subjects Interval 0.0 to 4.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 months of age (one month post-infant series)

Population: Per Protocol Population

Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=212 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=90 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects A (Pre-vaccination GMT; N= 177, 65)	2 Percentages of subjects Interval 1.0 to 6.0	3 Percentages of subjects Interval 0.0 to 11.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects A (Post-vaccination GMT; N= 212, 80)	71 Percentages of subjects Interval 65.0 to 77.0	1 Percentages of subjects Interval 0.03 to 7.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects C (Pre-vaccination GMT; N= 168, 64)	10 Percentages of subjects Interval 6.0 to 16.0	5 Percentages of subjects Interval 1.0 to 13.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects C (Post-vaccination GMT; N= 204, 84)	99 Percentages of subjects Interval 96.0 to 100.0	2 Percentages of subjects Interval 0.0 to 8.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects W (Pre-vaccination GMT; N= 165, 66)	22 Percentages of subjects Interval 16.0 to 30.0	15 Percentages of subjects Interval 8.0 to 26.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects W (Post-vaccination GMT; N=197, 90)	99 Percentages of subjects Interval 96.0 to 100.0	2 Percentages of subjects Interval 0.0 to 8.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects Y (Pre-vaccination GMT; N=150, 62 )	17 Percentages of subjects Interval 11.0 to 24.0	5 Percentages of subjects Interval 1.0 to 13.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects Y (Post-vaccination GMT; N=182, 84)	98 Percentages of subjects Interval 98.0 to 100.0	1 Percentages of subjects Interval 0.032 to 6.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 months of age (one month post-infant series)

Population: Per protocol population

Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=277 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=272 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects Y (Post-vaccination hSBA titer ≥1:8; N=272,263)	97 Percentages of subjects Interval 94.0 to 99.0	98 Percentages of subjects Interval 96.0 to 99.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects A (Pre-vaccination hSBA titer ≥1:8; N= 272, 271)	1 Percentages of subjects Interval 0.0 to 4.0	0 Percentages of subjects Interval 0.0 to 2.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects A (Post-vaccination hSBA titer ≥1:8; N= 277, 268)	74 Percentages of subjects Interval 69.0 to 79.0	89 Percentages of subjects Interval 85.0 to 93.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects C (Pre-vaccination hSBA titer ≥1:8; N= 273,272)	4 Percentages of subjects Interval 2.0 to 7.0	4 Percentages of subjects Interval 2.0 to 8.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects C (Post-vaccination hSBA titer ≥1:8; N= 277, 272)	94 Percentages of subjects Interval 90.0 to 96.0	97 Percentages of subjects Interval 94.0 to 99.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects W (Pre-vaccination hSBA titer ≥1:8; N= 263, 261)	16 Percentages of subjects Interval 12.0 to 21.0	10 Percentages of subjects Interval 7.0 to 14.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects W (Post-vaccination hSBA titer ≥1:8; N=271,264)	99 Percentages of subjects Interval 97.0 to 100.0	98 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects Y (Pre-vaccination hSBA titer ≥1:8; N=258, 260)	5 Percentages of subjects Interval 3.0 to 9.0	3 Percentages of subjects Interval 2.0 to 6.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 months of age (one month post-infant series)

Population: Per protocol population

Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=277 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=272 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects A (Pre-vaccination hSBA titer ≥1:4; N= 272, 271)	2 Percentages of subjects Interval 1.0 to 5.0	1 Percentages of subjects Interval 0.0 to 3.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects A (Post-vaccination hSBA titer ≥1:4; N= 277, 268)	78 Percentages of subjects Interval 73.0 to 83.0	91 Percentages of subjects Interval 87.0 to 94.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects C (Pre-vaccination hSBA titer ≥1:4; N= 273,272)	10 Percentages of subjects Interval 7.0 to 14.0	10 Percentages of subjects Interval 7.0 to 15.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects C (Post-vaccination hSBA titer ≥1:4; N= 277, 272)	96 Percentages of subjects Interval 93.0 to 98.0	98 Percentages of subjects Interval 96.0 to 99.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects W (Pre-vaccination hSBA titer ≥1:4; N= 263, 261)	17 Percentages of subjects Interval 13.0 to 23.0	13 Percentages of subjects Interval 9.0 to 17.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects W (Post-vaccination hSBA titer ≥1:4; N=271,264)	100 Percentages of subjects Interval 99.0 to 100.0	99 Percentages of subjects Interval 97.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects Y (Pre-vaccination hSBA titer ≥1:4; N=258, 260)	11 Percentages of subjects Interval 8.0 to 16.0	8 Percentages of subjects Interval 5.0 to 13.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects Y (Post-vaccination hSBA titer ≥1:4; N=272,263)	98 Percentages of subjects Interval 96.0 to 99.0	99 Percentages of subjects Interval 97.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 months of age (one month post-infant series)

Population: Per Protocol

Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=214 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=102 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Diphtheria (214, 102)	2.52 Titers Interval 2.28 to 2.78	2.88 Titers Interval 2.5 to 3.32	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Tetanus (214, 102)	2.5 Titers Interval 2.28 to 2.74	2.31 Titers Interval 2.01 to 2.64	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PT (174, 83)	54 Titers Interval 48.0 to 62.0	54 Titers Interval 44.0 to 66.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects FHA (174, 83)	118 Titers Interval 106.0 to 132.0	114 Titers Interval 97.0 to 134.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Pertactin (174, 83)	114 Titers Interval 100.0 to 130.0	110 Titers Interval 90.0 to 134.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Polio Type 1 (176, 98)	422 Titers Interval 363.0 to 491.0	441 Titers Interval 361.0 to 540.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Polio Type 2 (175, 98)	348 Titers Interval 297.0 to 408.0	290 Titers Interval 235.0 to 358.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Polio Type 3 (176, 98)	733 Titers Interval 607.0 to 885.0	635 Titers Interval 493.0 to 818.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Hepatitis B (N=148, N=98)	1863 Titers Interval 1538.0 to 2257.0	2112 Titers Interval 1668.0 to 2674.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Hib (N=213, N=101)	4.64 Titers Interval 3.9 to 5.53	3.56 Titers Interval 2.77 to 4.58	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 4 (N=181, N=102)	1.67 Titers Interval 1.5 to 1.86	2 Titers Interval 1.73 to 2.3	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 6B (N=181, N=102)	1.94 Titers Interval 1.61 to 2.34	2.55 Titers Interval 1.99 to 3.27	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 9V (N=181, N=102)	1.83 Titers Interval 1.62 to 2.06	2.15 Titers Interval 1.83 to 2.53	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 14 (N=181, N=102)	6.97 Titers Interval 6.18 to 7.86	6.79 Titers Interval 5.78 to 7.96	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 18C (N=181, N=102)	1.96 Titers Interval 1.75 to 2.19	2.54 Titers Interval 2.18 to 2.95	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 19F (N=181, N=102)	2.24 Titers Interval 2.02 to 2.48	2.73 Titers Interval 2.39 to 3.13	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 23F (N=181, N=102)	1.71 Titers Interval 1.47 to 1.98	2.15 Titers Interval 1.76 to 2.62	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 months of age (one month post-infant series)

Population: Per Protocol

Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=214 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=102 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Diphtheria (≥ 0.1 IU/mL) (214, 102)	100 Percentages of subjects Interval 97.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Tetanus (≥ 0.1 IU/mL) (214, 102)	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PT(≥ 4-fold rise) (174, 83)	87 Percentages of subjects Interval 81.0 to 92.0	86 Percentages of subjects Interval 76.0 to 92.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects FHA (≥ 4-fold rise) (174, 83)	85 Percentages of subjects Interval 79.0 to 90.0	80 Percentages of subjects Interval 69.0 to 88.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Pertactin (≥ 4-fold rise) (174, 83)	76 Percentages of subjects Interval 69.0 to 83.0	78 Percentages of subjects Interval 68.0 to 87.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Polio Type 1 (≥1:8) (176, 98)	99 Percentages of subjects Interval 97.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Polio Type 2 (≥1:8) (176, 98)	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Polio Type 3 (≥1:8)(175, 98)	99 Percentages of subjects Interval 97.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Hepatitis B (≥10 mIU/mL) (N=148, N=98)	99 Percentages of subjects Interval 96.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Hib (≥ 0.15 μg/mL) (N=213, N=101)	99 Percentages of subjects Interval 97.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects Hib (≥1.0 μg/mL) (N=213, N=101)	89 Percentages of subjects Interval 84.0 to 93.0	84 Percentages of subjects Interval 76.0 to 91.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 4 (≥ 0.35 μg/mL) (N=181, N=102)	98 Percentages of subjects Interval 95.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 6B (≥ 0.35 μg/mL) (N=181, N=102)	88 Percentages of subjects Interval 83.0 to 93.0	96 Percentages of subjects Interval 90.0 to 99.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 9V (≥ 0.35 μg/mL) (N=181, N=102)	98 Percentages of subjects Interval 94.0 to 99.0	98 Percentages of subjects Interval 93.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 14 (≥ 0.35 μg/mL) (N=181, N=102)	100 Percentages of subjects Interval 98.0 to 100.0	99 Percentages of subjects Interval 95.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 18C (≥ 0.35 μg/mL) (N=181, N=102)	97 Percentages of subjects Interval 94.0 to 99.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 19F (≥ 0.35 μg/mL) (N=181, N=102)	99 Percentages of subjects Interval 96.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects PnC 23F (≥ 0.35 μg/mL) (N=181, N=102)	92 Percentages of subjects Interval 87.0 to 95.0	94 Percentages of subjects Interval 88.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 months of age (one month post-infant series)

Population: Per Protocol

Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=287 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=123 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=283 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=137 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Diphtheria (N=287, N=123, N=283, N=137)	1.8 Titers Interval 1.62 to 1.99	1.54 Titers Interval 1.32 to 1.81	1.45 Titers Interval 1.31 to 1.61	1.77 Titers Interval 1.52 to 2.05	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Tetanus (N=287, N=123, N=283, N=137)	2.41 Titers Interval 2.23 to 2.6	2.19 Titers Interval 1.94 to 2.46	2.51 Titers Interval 2.33 to 2.71	2.65 Titers Interval 2.37 to 2.96	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PT (N=285, N=123, N=281, N=135)	47 Titers Interval 43.0 to 52.0	45 Titers Interval 39.0 to 53.0	45 Titers Interval 41.0 to 50.0	49 Titers Interval 42.0 to 56.0	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects FHA (N=286, N=123, N=281, N=135)	102 Titers Interval 93.0 to 112.0	97 Titers Interval 85.0 to 112.0	99 Titers Interval 91.0 to 109.0	112 Titers Interval 99.0 to 128.0	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Pertactin (N=286, N=123, N=281, N=135)	123 Titers Interval 110.0 to 137.0	124 Titers Interval 105.0 to 146.0	119 Titers Interval 106.0 to 133.0	149 Titers Interval 127.0 to 175.0	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Polio Type 1 (N=265, N=112, N=252, N=120)	535 Titers Interval 462.0 to 620.0	598 Titers Interval 477.0 to 749.0	533 Titers Interval 458.0 to 619.0	684 Titers Interval 550.0 to 850.0	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Polio Type 2 (N=265, N=112, N=252, N=120)	353 Titers Interval 302.0 to 411.0	366 Titers Interval 289.0 to 463.0	318 Titers Interval 271.0 to 372.0	385 Titers Interval 306.0 to 483.0	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Polio Type 3 (N=265, N=112, N=252, N=120)	710 Titers Interval 596.0 to 846.0	747 Titers Interval 571.0 to 977.0	656 Titers Interval 548.0 to 785.0	813 Titers Interval 627.0 to 1054.0	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Hepatitis B (N=243, N=104, N=237, N=118)	2273 Titers Interval 2001.0 to 2583.0	2045 Titers Interval 1682.0 to 2485.0	1900 Titers Interval 1670.0 to 2162.0	1993 Titers Interval 1660.0 to 2394.0	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Hib (N=287, N=123, N=283, N=137)	7.64 Titers Interval 6.63 to 8.8	6.01 Titers Interval 4.84 to 7.47	7.19 Titers Interval 6.23 to 8.29	6.74 Titers Interval 5.49 to 8.28	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 4 (N=268, N=116, N=256, N=126)	2.07 Titers Interval 1.88 to 2.27	2.24 Titers Interval 1.94 to 2.58	1.91 Titers Interval 1.74 to 2.1	2.39 Titers Interval 2.08 to 2.74	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 6B (N=264, N=116, N=255, N=124)	2.15 Titers Interval 1.85 to 2.49	2.21 Titers Interval 1.76 to 2.77	2.09 Titers Interval 1.8 to 2.44	2.4 Titers Interval 1.93 to 2.98	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 9V (N=268, N=116, N=256, N=126)	1.89 Titers Interval 1.71 to 2.1	2.21 Titers Interval 1.89 to 2.6	1.81 Titers Interval 1.63 to 2.02	2.19 Titers Interval 1.88 to 2.55	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 14 (N=268, N=116, N=256, N=126)	7.29 Titers Interval 6.42 to 8.29	8.06 Titers Interval 6.63 to 9.78	7.69 Titers Interval 6.75 to 8.77	9.18 Titers Interval 7.62 to 11.0	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 18C (N=268, N=116, N=256, N=126)	1.86 Titers Interval 1.68 to 2.07	2.09 Titers Interval 1.78 to 2.44	1.7 Titers Interval 1.53 to 1.89	2.26 Titers Interval 1.94 to 2.62	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 19F (N=268, N=116, N=254, N=126)	2.34 Titers Interval 2.1 to 2.6	2.6 Titers Interval 2.2 to 3.06	2.3 Titers Interval 2.06 to 2.57	2.53 Titers Interval 2.16 to 2.96	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 23F (N=267, N=115, N=256, N=125)	1.88 Titers Interval 1.64 to 2.16	2.46 Titers Interval 1.99 to 3.03	2.12 Titers Interval 1.84 to 2.44	2.42 Titers Interval 1.98 to 2.96	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 months of age (one month post-infant series)

Population: Per Protocol

Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=287 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=123 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=283 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=137 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Diphtheria(≥ 0.1 IU/mL) (N=287,N=123,N=283,N=137)	99 Percentages of subjects Interval 96.0 to 100.0	98 Percentages of subjects Interval 94.0 to 100.0	99 Percentages of subjects Interval 96.0 to 100.0	99 Percentages of subjects Interval 95.0 to 100.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Tetanus (≥ 0.1 IU/mL) (N=287,N=123,N=283,N=137)	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 97.0 to 100.0	100 Percentages of subjects Interval 99.0 to 100.0	100 Percentages of subjects Interval 97.0 to 100.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PT(≥ 4-fold rise) (N=285,N=123, N=281,N=135)	85 Percentages of subjects Interval 81.0 to 89.0	86 Percentages of subjects Interval 79.0 to 92.0	85 Percentages of subjects Interval 80.0 to 89.0	82 Percentages of subjects Interval 75.0 to 88.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects FHA (≥ 4-fold rise) (N=286,N=123, N=281,N=135)	84 Percentages of subjects Interval 79.0 to 88.0	86 Percentages of subjects Interval 79.0 to 92.0	82 Percentages of subjects Interval 77.0 to 86.0	81 Percentages of subjects Interval 74.0 to 88.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Pertactin(≥ 4-fold rise)(N=286,N=123,N=281,N=135)	81 Percentages of subjects Interval 76.0 to 85.0	87 Percentages of subjects Interval 80.0 to 92.0	86 Percentages of subjects Interval 82.0 to 90.0	88 Percentages of subjects Interval 81.0 to 93.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Polio Type 1 (≥1:8) (N=265,N=112,N=252,N=120)	98 Percentages of subjects Interval 95.0 to 99.0	100 Percentages of subjects Interval 97.0 to 100.0	99 Percentages of subjects Interval 97.0 to 100.0	98 Percentages of subjects Interval 94.0 to 100.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Polio Type 2 (≥1:8) (N=265,N=112,N=252,N=120)	97 Percentages of subjects Interval 95.0 to 99.0	99 Percentages of subjects Interval 95.0 to 100.0	98 Percentages of subjects Interval 95.0 to 99.0	98 Percentages of subjects Interval 93.0 to 99.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Polio Type 3 (≥1:8) (N=265,N=112,N=252,N=120)	97 Percentages of subjects Interval 95.0 to 99.0	97 Percentages of subjects Interval 92.0 to 99.0	96 Percentages of subjects Interval 93.0 to 98.0	97 Percentages of subjects Interval 92.0 to 99.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Hepatitis B(≥10 mIU/mL)(N=243,N=104,N=237,N=118)	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 97.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 97.0 to 100.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Hib (≥0.15 μg/mL) (N=287,N=123,N=283,N=137)	99 Percentages of subjects Interval 98.0 to 100.0	98 Percentages of subjects Interval 94.0 to 100.0	97 Percentages of subjects Interval 94.0 to 99.0	99 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects Hib (≥1.0 μg/mL) (N=287,N=123,N=283,N=137)	95 Percentages of subjects Interval 92.0 to 97.0	93 Percentages of subjects Interval 88.0 to 97.0	93 Percentages of subjects Interval 90.0 to 96.0	96 Percentages of subjects Interval 91.0 to 98.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 4 (≥ 0.35 μg/mL) (N=268,N=116,N=256,N=126)	99 Percentages of subjects Interval 96.0 to 100.0	99 Percentages of subjects Interval 95.0 to 100.0	97 Percentages of subjects Interval 94.0 to 99.0	98 Percentages of subjects Interval 94.0 to 100.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 6B (≥ 0.35 μg/mL) (N=264,N=116,N=255,N=124)	91 Percentages of subjects Interval 86.0 to 94.0	86 Percentages of subjects Interval 79.0 to 92.0	91 Percentages of subjects Interval 87.0 to 95.0	90 Percentages of subjects Interval 83.0 to 94.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 9V (≥ 0.35 μg/mL) (N=268,N=116,N=256,N=126)	97 Percentages of subjects Interval 95.0 to 99.0	98 Percentages of subjects Interval 94.0 to 100.0	97 Percentages of subjects Interval 94.0 to 99.0	96 Percentages of subjects Interval 91.0 to 99.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 14 (≥ 0.35 μg/mL) (N=268,N=116,N=256,N=126)	99 Percentages of subjects Interval 97.0 to 100.0	97 Percentages of subjects Interval 93.0 to 99.0	98 Percentages of subjects Interval 95.0 to 99.0	98 Percentages of subjects Interval 94.0 to 100.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 18C(≥ 0.35 μg/mL) (N=268,N=116,N=256, N=126)	97 Percentages of subjects Interval 94.0 to 98.0	98 Percentages of subjects Interval 94.0 to 100.0	95 Percentages of subjects Interval 91.0 to 97.0	98 Percentages of subjects Interval 94.0 to 100.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 19F (≥ 0.35 μg/mL)(N=268,N=116,N=254,N=126)	97 Percentages of subjects Interval 94.0 to 98.0	98 Percentages of subjects Interval 94.0 to 100.0	98 Percentages of subjects Interval 96.0 to 100.0	96 Percentages of subjects Interval 91.0 to 99.0	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects PnC 23F (≥ 0.35 μg/mL)(N=267,N=115,N=256, N=125)	93 Percentages of subjects Interval 89.0 to 96.0	97 Percentages of subjects Interval 91.0 to 99.0	95 Percentages of subjects Interval 91.0 to 97.0	94 Percentages of subjects Interval 88.0 to 97.0	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months of Age (one month pre-toddler vaccination)

Population: The analysis was done on per protocol population Per protocol was defined as subjects who: * received all the relevant doses of vaccine correctly * provided evaluable serum samples at the relevant time points * had no major protocol deviation as defined prior to database lock

Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=84 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=74 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject A (84, 74)	12 Percentages of subjects Interval 6.0 to 21.0	3 Percentages of subjects Interval 0.0 to 9.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject C (86, 73)	53 Percentages of subjects Interval 42.0 to 64.0	8 Percentages of subjects Interval 3.0 to 17.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject W (85, 73)	80 Percentages of subjects Interval 70.0 to 88.0	4 Percentages of subjects Interval 1.0 to 12.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject Y (84, 68)	74 Percentages of subjects Interval 63.0 to 83.0	1 Percentages of subjects Interval 0.0 to 8.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months of Age (one month pre-toddler vaccination)

Population: The analysis was done on per protocol population Per protocol was defined as subjects who: * received all the relevant doses of vaccine correctly * provided evaluable serum samples at the relevant time points * had no major protocol deviation as defined prior to database lock

Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=84 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=74 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject A (84, 74)	10 Percentages of subjects Interval 4.0 to 18.0	1 Percentages of subjects Interval 0.034 to 7.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject C (86, 73)	50 Percentages of subjects Interval 39.0 to 61.0	7 Percentages of subjects Interval 2.0 to 15.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject W (85, 73)	71 Percentages of subjects Interval 60.0 to 80.0	4 Percentages of subjects Interval 1.0 to 12.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject Y (84, 68)	61 Percentages of subjects Interval 49.0 to 71.0	1 Percentages of subjects Interval 0.037 to 8.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months of Age (one month pre-toddler vaccination)

Population: The analysis was done on per protocol population

Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=84 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=74 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Persistence Antibodies Geometric Mean Titers - US Subject A (84, 74)	2.51 Titers Interval 2.14 to 2.96	2.14 Titers Interval 1.8 to 2.54	—	—	—	—	—	—	—	—	—	—	—
Persistence Antibodies Geometric Mean Titers - US Subject C (86, 73)	7.72 Titers Interval 5.9 to 10.0	2.26 Titers Interval 1.69 to 3.03	—	—	—	—	—	—	—	—	—	—	—
Persistence Antibodies Geometric Mean Titers - US Subject W (85, 73)	14 Titers Interval 11.0 to 18.0	2.21 Titers Interval 1.69 to 2.9	—	—	—	—	—	—	—	—	—	—	—
Persistence Antibodies Geometric Mean Titers - US Subject Y (84, 68)	11 Titers Interval 8.76 to 15.0	2.14 Titers Interval 1.6 to 2.86	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 or 16 Months of Age (one month pre-toddler vaccination)

Population: The analysis was done on per protocol population

Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=206 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=78 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=229 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=102 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject A (205, 78, 229, 101)	29 Percentages of subjects Interval 23.0 to 36.0	1 Percentages of subjects Interval 0.032 to 7.0	18 Percentages of subjects Interval 14.0 to 24.0	1 Percentages of subjects Interval 0.025 to 5.0	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject C (206, 78, 229, 102)	62 Percentages of subjects Interval 55.0 to 68.0	4 Percentages of subjects Interval 1.0 to 11.0	32 Percentages of subjects Interval 26.0 to 38.0	2 Percentages of subjects Interval 0.0 to 7.0	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject W (198, 70, 218, 98)	95 Percentages of subjects Interval 92.0 to 98.0	4 Percentages of subjects Interval 1.0 to 12.0	72 Percentages of subjects Interval 66.0 to 78.0	5 Percentages of subjects Interval 2.0 to 12.0	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject Y (195, 71, 212, 95)	82 Percentages of subjects Interval 76.0 to 87.0	3 Percentages of subjects Interval 0.0 to 10.0	65 Percentages of subjects Interval 58.0 to 71.0	2 Percentages of subjects Interval 0.0 to 7.0	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 or 16 Months of Age (one month pre-toddler vaccination)

Population: The analysis was done on per protocol population

Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=206 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=78 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=229 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=102 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject A (205, 78, 229, 101)	25 Percentages of subjects Interval 20.0 to 32.0	0 Percentages of subjects Interval 0.0 to 5.0	15 Percentages of subjects Interval 11.0 to 20.0	0 Percentages of subjects Interval 0.0 to 4.0	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject C (206, 78, 229, 102)	57 Percentages of subjects Interval 50.0 to 64.0	4 Percentages of subjects Interval 1.0 to 11.0	26 Percentages of subjects Interval 20.0 to 32.0	1 Percentages of subjects Interval 0.025 to 5.0	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject W (198, 70, 218, 98)	85 Percentages of subjects Interval 79.0 to 90.0	4 Percentages of subjects Interval 1.0 to 12.0	63 Percentages of subjects Interval 56.0 to 69.0	5 Percentages of subjects Interval 2.0 to 12.0	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject Y (195, 71, 212, 95)	72 Percentages of subjects Interval 65.0 to 78.0	3 Percentages of subjects Interval 0.0 to 10.0	52 Percentages of subjects Interval 45.0 to 59.0	0 Percentages of subjects Interval 0.0 to 4.0	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 or 16 Months of Age (one month pre-toddler vaccination)

Population: The analysis was done on per protocol population

Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=206 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=78 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=229 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) n=102 Participants US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Persistence Antibodies Geometric Mean Titers - LA Subjects A (205, 78, 229, 101)	4.26 Titers Interval 3.55 to 5.11	2.02 Titers Interval 1.7 to 2.4	2.96 Titers Interval 2.63 to 3.33	2.02 Titers Interval 1.74 to 2.35	—	—	—	—	—	—	—	—	—
Persistence Antibodies Geometric Mean Titers - LA Subjects C (206, 78, 229, 102)	12 Titers Interval 9.33 to 15.0	2.18 Titers Interval 1.73 to 2.74	4.14 Titers Interval 3.54 to 4.84	2.05 Titers Interval 1.68 to 2.51	—	—	—	—	—	—	—	—	—
Persistence Antibodies Geometric Mean Titers - LA Subjects W (198, 70, 218, 98)	31 Titers Interval 26.0 to 37.0	2.34 Titers Interval 1.79 to 3.05	14 Titers Interval 12.0 to 18.0	2.33 Titers Interval 1.86 to 2.91	—	—	—	—	—	—	—	—	—
Persistence Antibodies Geometric Mean Titers - LA Subjects Y (195, 71, 212, 95)	18 Titers Interval 15.0 to 22.0	2.2 Titers Interval 1.7 to 2.84	9.45 Titers Interval 7.81 to 11.0	2.04 Titers Interval 1.64 to 2.55	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 13 months of age (one month post-toddler vaccination)

Population: The analysis was done on per protocol population

Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=84 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=74 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects A Pre-vaccination (84, 74)	12 Percentages of subjects Interval 6.0 to 21.0	3 Percentages of subjects Interval 0.0 to 9.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects A Post-vaccination (84, 74)	94 Percentages of subjects Interval 87.0 to 98.0	78 Percentages of subjects Interval 67.0 to 87.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects C Pre-vaccination (86, 73)	53 Percentages of subjects Interval 42.0 to 64.0	8 Percentages of subjects Interval 3.0 to 17.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects C Post-vaccination (86, 73)	99 Percentages of subjects Interval 94.0 to 100.0	95 Percentages of subjects Interval 87.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects W Pre-vaccination (85, 73)	80 Percentages of subjects Interval 70.0 to 88.0	4 Percentages of subjects Interval 1.0 to 12.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects W Post-vaccination (85, 73)	100 Percentages of subjects Interval 6.0 to 100.0	73 Percentages of subjects Interval 61.0 to 82.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects Y Pre-vaccination (84, 68)	74 Percentages of subjects Interval 63.0 to 83.0	1 Percentages of subjects Interval 0.037 to 8.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects Y Post-vaccination (84, 68)	100 Percentages of subjects Interval 96.0 to 100.0	62 Percentages of subjects Interval 49.0 to 73.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 13 months of age (one month post-toddler vaccination)

Population: The analysis was done on per protocol population

Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=84 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=74 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects A Pre-vaccination (84, 74)	10 Percentages of subjects Interval 4.0 to 18.0	1 Percentages of subjects Interval 0.034 to 7.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects A Post-vaccination (84, 74)	94 Percentages of subjects Interval 87.0 to 98.0	72 Percentages of subjects Interval 60.0 to 81.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects C Pre-vaccination (86, 73)	50 Percentages of subjects Interval 39.0 to 61.0	7 Percentages of subjects Interval 2.0 to 15.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects C Post-vaccination (86, 73)	98 Percentages of subjects Interval 92.0 to 100.0	90 Percentages of subjects Interval 81.0 to 96.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects W Pre-vaccination (85, 73)	71 Percentages of subjects Interval 60.0 to 80.0	4 Percentages of subjects Interval 1.0 to 12.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects W Post-vaccination (85, 73)	100 Percentages of subjects Interval 96.0 to 100.0	58 Percentages of subjects Interval 45.0 to 69.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects Y Pre-vaccination (84, 68)	61 Percentages of subjects Interval 49.0 to 71.0	1 Percentages of subjects Interval 0.037 to 8.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects Y Post-vaccination (84, 68)	100 Percentages of subjects Interval 96.0 to 100.0	56 Percentages of subjects Interval 43.0 to 68.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 13 months of age (one month post-toddler vaccination)

Population: The analysis was done on per protocol population

Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=86 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=74 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects A Pre-vaccination (84, 74)	5 Percentages of subjects Interval 1.0 to 12.0	1 Percentages of subjects Interval 0.034 to 7.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects A Post-vaccination (84, 74)	90 Percentages of subjects Interval 82.0 to 96.0	55 Percentages of subjects Interval 43.0 to 67.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects C Pre-vaccination (86, 73)	35 Percentages of subjects Interval 25.0 to 46.0	0 Percentages of subjects Interval 0.0 to 5.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects C Post-vaccination (86, 73)	95 Percentages of subjects Interval 89.0 to 99.0	78 Percentages of subjects Interval 67.0 to 87.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects W Pre-vaccination (85, 73)	48 Percentages of subjects Interval 37.0 to 59.0	3 Percentages of subjects Interval 0.0 to 10.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects W Post-vaccination (85, 73)	100 Percentages of subjects Interval 96.0 to 100.0	38 Percentages of subjects Interval 27.0 to 50.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects Y Pre-vaccination (84, 68)	45 Percentages of subjects Interval 34.0 to 56.0	1 Percentages of subjects Interval 0.037 to 8.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects Y Post-vaccination (84, 68)	100 Percentages of subjects Interval 96.0 to 100.0	41 Percentages of subjects Interval 29.0 to 54.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 13 months of age (one month post-toddler vaccination)

Population: The analysis was done on per protocol population

Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=84 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=74 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects A Pre-vaccination (84, 74)	2.51 Titers Interval 2.14 to 2.96	2.14 Titers Interval 1.8 to 2.54	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects A Post-vaccination (84, 74)	77 Titers Interval 55.0 to 109.0	17 Titers Interval 12.0 to 25.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects C Pre-vaccination (86, 73)	7.72 Titers Interval 5.9 to 10.0	2.26 Titers Interval 1.69 to 3.03	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects C Post-vaccination (86, 73)	227 Titers Interval 155.0 to 332.0	35 Titers Interval 23.0 to 54.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects W Pre-vaccination (85, 73)	14 Titers Interval 11.0 to 18.0	2.21 Titers Interval 1.69 to 2.9	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects W Post-vaccination (85, 73)	416 Titers Interval 288.0 to 602.0	11 Titers Interval 7.59 to 17.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects Y Pre-vaccination (84, 68)	11 Titers Interval 8.76 to 15.0	2.14 Titers Interval 1.6 to 2.86	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects Y Post-vaccination (84, 68)	395 Titers Interval 269.0 to 580.0	10 Titers Interval 6.72 to 16.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 13 or 17 Months of Age (one month post-toddler vaccination)

Population: The analysis was done on per protocol population

Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=103 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=122 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects A Pre-vaccination (103, 120)	28 Percentages of subjects Interval 20.0 to 38.0	18 Percentages of subjects Interval 12.0 to 26.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects A Post-vaccination (103,120)	94 Percentages of subjects Interval 88.0 to 98.0	95 Percentages of subjects Interval 89.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects C Pre-vaccination (102,122)	61 Percentages of subjects Interval 51.0 to 70.0	30 Percentages of subjects Interval 22.0 to 38.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects C Post-vaccination (102,122)	98 Percentages of subjects Interval 93.0 to 100.0	98 Percentages of subjects Interval 94.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects W Pre-vaccination (98,112)	97 Percentages of subjects Interval 91.0 to 99.0	71 Percentages of subjects Interval 61.0 to 79.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects W Post-vaccination (98,112)	100 Percentages of subjects Interval 96.0 to 100.0	100 Percentages of subjects Interval 97.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects Y Pre-vaccination (98,109)	78 Percentages of subjects Interval 68.0 to 85.0	61 Percentages of subjects Interval 52.0 to 71.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects Y Post-vaccination (98,109)	99 Percentages of subjects Interval 94.0 to 100.0	99 Percentages of subjects Interval 95.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 13 or 17 Months of Age (one month post-toddler vaccination)

Population: The analysis was done on per protocol population

Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=103 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=122 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects A Pre-vaccination (103, 120)	23 Percentages of subjects Interval 16.0 to 33.0	13 Percentages of subjects Interval 8.0 to 21.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects A Post-vaccination (103,120)	94 Percentages of subjects Interval 88.0 to 98.0	95 Percentages of subjects Interval 89.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects C Pre-vaccination (102,122)	57 Percentages of subjects Interval 47.0 to 67.0	22 Percentages of subjects Interval 15.0 to 31.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects C Post-vaccination (102,122)	97 Percentages of subjects Interval 92.0 to 99.0	98 Percentages of subjects Interval 94.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects W Pre-vaccination (98,112)	84 Percentages of subjects Interval 75.0 to 90.0	62 Percentages of subjects Interval 52.0 to 71.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects W Post-vaccination (98,112)	99 Percentages of subjects Interval 94.0 to 100.0	100 Percentages of subjects Interval 97.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects Y Pre-vaccination (98,109)	67 Percentages of subjects Interval 57.0 to 76.0	47 Percentages of subjects Interval 37.0 to 57.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects Y Post-vaccination (98,109)	99 Percentages of subjects Interval 94.0 to 100.0	99 Percentages of subjects Interval 95.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 13 or 17 Months of Age (one month post-toddler vaccination)

Population: The analysis was done on per protocol population

Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=103 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=122 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects A Pre-vaccination (103, 120)	16 Percentages of subjects Interval 9.0 to 24.0	9 Percentages of subjects Interval 5.0 to 16.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects A Post-vaccination (103, 120)	93 Percentages of subjects Interval 86.0 to 97.0	94 Percentages of subjects Interval 88.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects C Pre-vaccination (102, 122)	47 Percentages of subjects Interval 37.0 to 57.0	18 Percentages of subjects Interval 12.0 to 26.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects C Post-vaccination (102, 122)	95 Percentages of subjects Interval 89.0 to 98.0	96 Percentages of subjects Interval 91.0 to 99.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects W Pre-vaccination (98,112)	64 Percentages of subjects Interval 54.0 to 74.0	50 Percentages of subjects Interval 40.0 to 60.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects W Post-vaccination (98, 112)	99 Percentages of subjects Interval 94.0 to 100.0	100 Percentages of subjects Interval 97.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects Y Pre-vaccination (98,109)	53 Percentages of subjects Interval 43.0 to 63.0	32 Percentages of subjects Interval 23.0 to 42.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects Y Post-vaccination (98, 109)	99 Percentages of subjects Interval 94.0 to 100.0	98 Percentages of subjects Interval 94.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 13 or 17 Months of Age (one month post-toddler vaccination)

Population: The analysis was done on per protocol population

Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=103 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=122 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects A Pre-vaccination (103, 120)	3.83 Titers Interval 3.3 to 4.45	2.95 Titers Interval 2.57 to 3.39	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects A Post-vaccination (103, 120)	112 Titers Interval 85.0 to 148.0	146 Titers Interval 113.0 to 188.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects C Pre-vaccination (102, 122)	11 Titers Interval 8.91 to 13.0	3.83 Titers Interval 3.2 to 4.6	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects C Post-vaccination (102, 122)	279 Titers Interval 218.0 to 358.0	283 Titers Interval 225.0 to 355.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects W Pre-vaccination (98, 112)	28 Titers Interval 22.0 to 34.0	13 Titers Interval 11.0 to 16.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects W Post-vaccination (98, 112)	762 Titers Interval 604.0 to 960.0	727 Titers Interval 586.0 to 903.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects Y Pre-vaccination (98, 109)	16 Titers Interval 13.0 to 20.0	8.1 Titers Interval 6.58 to 9.96	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects Y Post-vaccination (98, 109)	550 Titers Interval 426.0 to 710.0	590 Titers Interval 463.0 to 751.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 13 months of age (one month post-toddler vaccination)

Population: Per Protocol

Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=87 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=99 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects PnC 4 (N=86, N=99)	2.9 Titers Interval 2.33 to 3.61	3.24 Titers Interval 2.64 to 3.97	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects PnC 6B (N=86, N=99)	6.82 Titers Interval 5.67 to 8.21	8.58 Titers Interval 7.22 to 10.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects PnC 9V (N=86, N=99)	2.8 Titers Interval 2.26 to 3.47	3.13 Titers Interval 2.56 to 3.82	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects PnC 14 (N=86, N=99)	12 Titers Interval 9.74 to 14.0	15 Titers Interval 12.0 to 17.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects PnC 18C (N=87, N=98)	2.76 Titers Interval 2.26 to 3.38	2.71 Titers Interval 2.24 to 3.27	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects PnC 19F(N=86, N=99)	3.63 Titers Interval 3.0 to 4.39	3.48 Titers Interval 2.92 to 4.16	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects PnC 23F (N=87, N=99)	5.31 Titers Interval 4.2 to 6.71	5.63 Titers Interval 4.52 to 7.01	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 13 months of age (one month post-toddler vaccination)

Population: Per Protocol

Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=87 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=99 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) n=81 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects PnC 4 (N=86, N=99, N=81)	91 Percentages of subjects Interval 82.0 to 96.0	90 Percentages of subjects Interval 82.0 to 95.0	84 Percentages of subjects Interval 74.0 to 91.0	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects PnC 6B (N=86, N=99, N=80)	100 Percentages of subjects Interval 96.0 to 100.0	96 Percentages of subjects Interval 90.0 to 99.0	99 Percentages of subjects Interval 93.0 to 100.0	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects PnC 9V (N=86, N=99, N=80)	87 Percentages of subjects Interval 78.0 to 93.0	91 Percentages of subjects Interval 83.0 to 96.0	86 Percentages of subjects Interval 77.0 to 93.0	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects PnC 14 (N=86, N=99, N=81)	99 Percentages of subjects Interval 94.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects PnC 18C (N=87, N=98, N=81)	86 Percentages of subjects Interval 77.0 to 93.0	92 Percentages of subjects Interval 85.0 to 96.0	94 Percentages of subjects Interval 86.0 to 98.0	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects PnC 19F(N=86, N=99, N=80)	97 Percentages of subjects Interval 90.0 to 99.0	93 Percentages of subjects Interval 86.0 to 97.0	99 Percentages of subjects Interval 93.0 to 100.0	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects PnC 23F (N=87, N=99, N=80)	93 Percentages of subjects Interval 86.0 to 97.0	95 Percentages of subjects Interval 89.0 to 98.0	99 Percentages of subjects Interval 93.0 to 100.0	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 13 months of age (one month post-toddler vaccination)

Population: Per Protocol

Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=97 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=97 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects PnC 23F (N=97, N=97)	4.38 Concentrations (μg/mL) Interval 3.51 to 5.48	5.92 Concentrations (μg/mL) Interval 4.74 to 7.4	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects PnC 19F (N=97, N=97)	3.26 Concentrations (μg/mL) Interval 2.62 to 4.05	4.26 Concentrations (μg/mL) Interval 3.43 to 5.29	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects PnC 4 (N=97, N=97)	3.16 Concentrations (μg/mL) Interval 2.63 to 3.8	4.02 Concentrations (μg/mL) Interval 3.34 to 4.83	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects PnC 6B (N=96, N=97)	4.52 Concentrations (μg/mL) Interval 3.42 to 5.97	5.61 Concentrations (μg/mL) Interval 4.25 to 7.4	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects PnC 9V (N=97, N=97)	2.79 Concentrations (μg/mL) Interval 2.34 to 3.31	3.77 Concentrations (μg/mL) Interval 3.17 to 4.48	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects PnC 14(N=97, N=97)	8.91 Concentrations (μg/mL) Interval 7.52 to 11.0	14 Concentrations (μg/mL) Interval 12.0 to 16.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects PnC 18C (N=97, N=97)	2.15 Concentrations (μg/mL) Interval 1.79 to 2.58	2.77 Concentrations (μg/mL) Interval 2.31 to 3.32	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 13 months of age (one month post-toddler vaccination)

Population: Per Protocol

Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=97 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=97 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects PnC 19F (N=97, N=97)	90 Percentages of subjects Interval 82.0 to 95.0	93 Percentages of subjects Interval 86.0 to 97.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects PnC 18C (N=97, N=97)	80 Percentages of subjects Interval 71.0 to 88.0	95 Percentages of subjects Interval 88.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects PnC 23F (N=97, N=97)	95 Percentages of subjects Interval 88.0 to 98.0	95 Percentages of subjects Interval 88.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects PnC 4 (N=97, N=97)	93 Percentages of subjects Interval 86.0 to 97.0	95 Percentages of subjects Interval 88.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects PnC 6B (N=96, N=97)	86 Percentages of subjects Interval 78.0 to 93.0	89 Percentages of subjects Interval 81.0 to 94.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects PnC 9V (N=97, N=97)	92 Percentages of subjects Interval 84.0 to 96.0	95 Percentages of subjects Interval 88.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects PnC 14 (N=97, N=97)	99 Percentages of subjects Interval 94.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 17 months of age (one month post-toddler vaccination)

Population: Per Protocol

Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=118 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=101 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects Diphtheria (N=118, N=101)	5.4 Titers Interval 4.74 to 6.15	5.16 Titers Interval 4.48 to 5.94	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects Tetanus (N=118, N=101)	6.17 Titers Interval 5.29 to 7.2	6.58 Titers Interval 5.57 to 7.77	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects PT (N=113, N=99)	68 Titers Interval 58.0 to 80.0	62 Titers Interval 52.0 to 73.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects FHA (N=113, N=99)	245 Titers Interval 208.0 to 288.0	215 Titers Interval 181.0 to 256.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects Pertactin (N=113, N=99)	238 Titers Interval 198.0 to 286.0	197 Titers Interval 161.0 to 240.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects Hib (N=117, N=101)	35 Titers Interval 28.0 to 43.0	41 Titers Interval 32.0 to 51.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 17 months of age (one month post-toddler vaccination)

Population: Per Protocol

Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=118 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=101 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects Pertactin (≥4-fold rise) (N=113, N=99)	89 Percentages of subjects Interval 82.0 to 94.0	88 Percentages of subjects Interval 80.0 to 94.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects Hib (≥0.15 μg/mL) (N=117, N=101)	100 Percentages of subjects Interval 97.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects Hib (≥1.0 μg/mL) (N=117, N=101)	100 Percentages of subjects Interval 97.0 to 100.0	99 Percentages of subjects Interval 95.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects Diphtheria (≥1.0 IU/mL) (N=118, N=101)	98 Percentages of subjects Interval 94.0 to 100.0	98 Percentages of subjects Interval 93.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects Tetanus (≥1.0 IU/mL) (N=118, N=101)	98 Percentages of subjects Interval 94.0 to 100.0	98 Percentages of subjects Interval 93.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects PT (≥4 fold rise) (N=113, N=99)	89 Percentages of subjects Interval 82.0 to 94.0	84 Percentages of subjects Interval 75.0 to 90.0	—	—	—	—	—	—	—	—	—	—	—
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects FHA (≥4-fold rise) (N=113, N=99)	87 Percentages of subjects Interval 79.0 to 92.0	88 Percentages of subjects Interval 80.0 to 94.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)

Population: The analysis was done on per protocol population

Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=78 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=102 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects A Pre-vaccination (78, 101)	0 Percentages of subjects Interval 0.0 to 5.0	0 Percentages of subjects Interval 0.0 to 4.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects A Post-vaccination ((78, 101)	74 Percentages of subjects Interval 63.0 to 84.0	97 Percentages of subjects Interval 92.0 to 99.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects C Pre-vaccination (78, 102)	4 Percentages of subjects Interval 1.0 to 11.0	1 Percentages of subjects Interval 0.025 to 5.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects C Post-vaccination (78, 102)	91 Percentages of subjects Interval 82.0 to 96.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects W Pre-vaccination (70, 98)	4 Percentages of subjects Interval 1.0 to 12.0	5 Percentages of subjects Interval 2.0 to 12.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects W Post-vaccination (70, 98)	79 Percentages of subjects Interval 67.0 to 87.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects Y Pre-vaccination (71, 95)	3 Percentages of subjects Interval 0.0 to 10.0	0 Percentages of subjects Interval 0.0 to 4.0	—	—	—	—	—	—	—	—	—	—	—
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects Y Post-vaccination (71, 95)	72 Percentages of subjects Interval 60.0 to 82.0	100 Percentages of subjects Interval 96.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)

Population: The analysis was done on per protocol population

Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.

Outcome measures

Measure	US1A (MenACWY- CRM + Infant Vaccines) n=78 Participants US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.	US2 (Infant Vaccine Only) n=108 Participants received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.	US1 (MenACWY-CRM + Infant Vaccines) US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.	US2 (Infant Vaccines Only) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	US3 (MenACWY-CRM + Infant Vaccines) US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.	US4 (Infant Vaccines Only ) US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.	LA1 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.	LA2 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.	LA3 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.	LA4 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.	LA5 (MenACWY-CRM + Infant Vaccines) LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.	LA6 (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.	LA6C (Infant Vaccines Only) LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects A Pre-vaccination (78, 101)	2.02 Titers Interval 1.7 to 2.4	2.02 Titers Interval 1.74 to 2.35	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects A Post-vaccination (78, 101)	25 Titers Interval 18.0 to 34.0	128 Titers Interval 97.0 to 169.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects C Pre-vaccination (78, 102)	2.18 Titers Interval 1.73 to 2.74	2.05 Titers Interval 1.68 to 2.51	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects C Post-vaccination (78, 102)	45 Titers Interval 34.0 to 60.0	501 Titers Interval 391.0 to 643.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects W Pre-vaccination (70, 98)	2.34 Titers Interval 1.79 to 3.05	2.33 Titers Interval 1.86 to 2.91	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects W Post-vaccination (70, 98)	22 Titers Interval 16.0 to 28.0	394 Titers Interval 313.0 to 497.0	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects Y Pre-vaccination (71, 95)	2.2 Titers Interval 1.7 to 2.84	2.04 Titers Interval 1.64 to 2.55	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects Y Post-vaccination (71, 95)	15 Titers Interval 11.0 to 20.0	329 Titers Interval 254.0 to 426.0	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

US1+US3

Serious events: 58 serious events

Other events: 957 other events

Deaths: 0 deaths

US2+US4A+US4B

Serious events: 18 serious events

Other events: 279 other events

Deaths: 0 deaths

US4C

Serious events: 14 serious events

Other events: 202 other events

Deaths: 0 deaths

LA1+LA3+LA5

Serious events: 173 serious events

Other events: 1946 other events

Deaths: 0 deaths

LA2+4+6AB

Serious events: 84 serious events

Other events: 795 other events

Deaths: 0 deaths

LA6C

Serious events: 12 serious events

Other events: 178 other events

Deaths: 0 deaths

Serious adverse events

Measure	US1+US3 n=995 participants at risk Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).	US2+US4A+US4B n=301 participants at risk Groups Infant Vaccines only (US2, US4A, and US4B) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received: 1. One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age ( US2 and US4A). 2. Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B)	US4C n=203 participants at risk US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.	LA1+LA3+LA5 n=2026 participants at risk Groups Men ACWY-CRM + Infant Vaccines (LA1, LA3 and LA5) pooled LA infants received MenACWY at 2 and 6 months of age; and DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received at 12 months of age pneumococcal conjugate vaccine, HAV, and MMR-V and concomitant third dose of MenACWY (LA1A) or a third dose of MenACWY at 13 months of age (LA1B). LA infants received MenACWY, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. At 12 months of age these infants received pneumococcal conjugate vaccine, HAV, and MMR-V and received: 1. Fourth dose of MenACWY concomitantly with DTaP and Hib at 16 months of age (LA3A) 2. DTaP and Hib at 16 months and fourth dose of MenACWY at 17 months of age (LA3B). 3. Concomitantly the fourth dose of MenACWY (LA5).	LA2+4+6AB n=824 participants at risk Groups Infant Vaccines only (LA2, LA4, LA6A and LA6B) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants either received: one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY at 15 months of age (LA2 and LA4) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B).	LA6C n=183 participants at risk LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.55% 1/183
Blood and lymphatic system disorders LYMPHADENITIS	0.00% 0/995	0.33% 1/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Cardiac disorders CYANOSIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.12% 1/824	0.00% 0/183
Cardiac disorders PULMONARY VALVE STENOSIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Congenital, familial and genetic disorders ATRIAL SEPTAL DEFECT	0.00% 0/995	0.33% 1/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Congenital, familial and genetic disorders FALLOT'S TETRALOGY	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Congenital, familial and genetic disorders HYPOSPADIAS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Congenital, familial and genetic disorders OPTIC NERVE HYPOPLASIA	0.00% 0/995	0.00% 0/301	0.49% 1/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Congenital, familial and genetic disorders PYLORIC STENOSIS	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Ear and labyrinth disorders HAEMATOTYMPANUM	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Eye disorders BLEPHARITIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Gastrointestinal disorders DIARRHOEA	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.39% 8/2026	0.49% 4/824	0.00% 0/183
Gastrointestinal disorders DIARRHOEA HAEMORRHAGIC	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Gastrointestinal disorders GASTRITIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.24% 2/824	0.00% 0/183
Gastrointestinal disorders HAEMATOCHEZIA	0.10% 1/995	0.33% 1/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Gastrointestinal disorders INGUINAL HERNIA	0.00% 0/995	0.33% 1/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.00% 0/995	0.00% 0/301	0.49% 1/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Gastrointestinal disorders INTUSSUSCEPTION	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Gastrointestinal disorders NAUSEA	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Gastrointestinal disorders PERITONITIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Gastrointestinal disorders STOMATITIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.12% 1/824	0.00% 0/183
Gastrointestinal disorders VOMITING	0.10% 1/995	0.33% 1/301	0.00% 0/203	0.20% 4/2026	0.36% 3/824	0.55% 1/183
General disorders OEDEMA	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
General disorders PYREXIA	0.30% 3/995	0.00% 0/301	0.00% 0/203	0.25% 5/2026	0.61% 5/824	0.55% 1/183
Immune system disorders DRUG HYPERSENSITIVITY	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Immune system disorders FOOD ALLERGY	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Immune system disorders HYPOGAMMAGLOBULINAEMIA	0.00% 0/995	0.33% 1/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Infections and infestations ABSCESS LIMB	0.10% 1/995	0.00% 0/301	0.49% 1/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Infections and infestations ABSCESS NECK	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Infections and infestations ABSCESS ORAL	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Infections and infestations ACARODERMATITIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations ACUTE SINUSITIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations ARTHRITIS BACTERIAL	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Infections and infestations BACTERAEMIA	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.10% 2/2026	0.00% 0/824	0.00% 0/183
Infections and infestations BACTERIAL DIARRHOEA	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.15% 3/2026	0.73% 6/824	0.00% 0/183
Infections and infestations BOTULISM	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations BRONCHIOLITIS	1.0% 10/995	1.00% 3/301	0.99% 2/203	1.6% 32/2026	1.9% 16/824	3.3% 6/183
Infections and infestations BRONCHITIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.30% 6/2026	0.12% 1/824	1.1% 2/183
Infections and infestations BRONCHITIS VIRAL	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations BRONCHOPNEUMONIA	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations CELLULITIS	0.30% 3/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.55% 1/183
Infections and infestations CROUP INFECTIOUS	0.10% 1/995	0.00% 0/301	0.49% 1/203	0.15% 3/2026	0.00% 0/824	0.00% 0/183
Infections and infestations DENGUE FEVER	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.24% 2/824	0.00% 0/183
Infections and infestations ENTERITIS INFECTIOUS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Infections and infestations EXANTHEMA SUBITUM	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations FEBRILE INFECTION	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations GASTROENTERITIS	0.20% 2/995	0.00% 0/301	0.99% 2/203	0.69% 14/2026	0.49% 4/824	0.00% 0/183
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/995	0.33% 1/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations IMPETIGO	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations INFECTIOUS MONONUCLEOSIS	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations INFLUENZA	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Infections and infestations LUNG INFECTION	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations OSTEOMYELITIS	0.00% 0/995	0.33% 1/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Infections and infestations OTITIS MEDIA	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.49% 4/824	0.00% 0/183
Infections and infestations OTITIS MEDIA ACUTE	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations PERIORBITAL CELLULITIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.10% 2/2026	0.24% 2/824	0.00% 0/183
Infections and infestations PERTUSSIS	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.10% 2/2026	0.24% 2/824	0.00% 0/183
Infections and infestations PHARYNGITIS	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Infections and infestations PNEUMONIA	0.40% 4/995	0.66% 2/301	0.49% 1/203	1.8% 37/2026	1.1% 9/824	1.1% 2/183
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.25% 5/2026	0.24% 2/824	0.00% 0/183
Infections and infestations PNEUMONIA PRIMARY ATYPICAL	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.10% 2/2026	0.00% 0/824	0.00% 0/183
Infections and infestations PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL	0.00% 0/995	0.33% 1/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Infections and infestations PNEUMONIA VIRAL	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.10% 2/2026	0.12% 1/824	0.00% 0/183
Infections and infestations RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS	0.40% 4/995	1.3% 4/301	0.49% 1/203	0.00% 0/2026	0.00% 0/824	0.55% 1/183
Infections and infestations RESPIRATORY SYNCYTIAL VIRUS INFECTION	0.30% 3/995	0.00% 0/301	0.00% 0/203	0.10% 2/2026	0.00% 0/824	0.00% 0/183
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/995	0.00% 0/301	0.49% 1/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations RESPIRATORY TRACT INFECTION VIRAL	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations SEPSIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations SINUSITIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Infections and infestations STAPHYLOCOCCAL ABSCESS	0.20% 2/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Infections and infestations STAPHYLOCOCCAL INFECTION	0.20% 2/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Infections and infestations STAPHYLOCOCCAL SKIN INFECTION	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Infections and infestations SUBCUTANEOUS ABSCESS	0.00% 0/995	0.00% 0/301	0.49% 1/203	0.20% 4/2026	0.00% 0/824	0.00% 0/183
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations URINARY TRACT INFECTION	0.10% 1/995	0.33% 1/301	0.00% 0/203	0.44% 9/2026	0.97% 8/824	0.00% 0/183
Infections and infestations VARICELLA	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Infections and infestations VIRAL DIARRHOEA	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Infections and infestations VIRAL INFECTION	0.10% 1/995	0.00% 0/301	0.49% 1/203	0.05% 1/2026	0.24% 2/824	0.00% 0/183
Infections and infestations VIRAL PHARYNGITIS	0.00% 0/995	0.33% 1/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Infections and infestations VULVAL ABSCESS	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Injury, poisoning and procedural complications ACCIDENTAL DRUG INTAKE BY CHILD	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Injury, poisoning and procedural complications ACCIDENTAL EXPOSURE	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Injury, poisoning and procedural complications BURNS SECOND DEGREE	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Injury, poisoning and procedural complications FOREIGN BODY	0.00% 0/995	0.33% 1/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Injury, poisoning and procedural complications HEAD INJURY	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.10% 2/2026	0.00% 0/824	0.00% 0/183
Injury, poisoning and procedural complications LIMB TRAUMATIC AMPUTATION	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Injury, poisoning and procedural complications RIB FRACTURE	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Injury, poisoning and procedural complications SKULL FRACTURE	0.00% 0/995	0.33% 1/301	0.00% 0/203	0.10% 2/2026	0.00% 0/824	0.00% 0/183
Injury, poisoning and procedural complications THERMAL BURN	0.00% 0/995	0.00% 0/301	0.49% 1/203	0.10% 2/2026	0.00% 0/824	0.00% 0/183
Injury, poisoning and procedural complications TRAUMATIC BRAIN INJURY	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.10% 2/2026	0.00% 0/824	0.00% 0/183
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Metabolism and nutrition disorders COW'S MILK INTOLERANCE	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Metabolism and nutrition disorders DEHYDRATION	0.50% 5/995	0.33% 1/301	0.99% 2/203	0.05% 1/2026	0.12% 1/824	1.1% 2/183
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Metabolism and nutrition disorders DIABETIC KETOACIDOSIS	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Musculoskeletal and connective tissue disorders SYNOSTOSIS	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE MYELOID LEUKAEMIA	0.00% 0/995	0.00% 0/301	0.49% 1/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRAIN NEOPLASM	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Nervous system disorders COMPLEX PARTIAL SEIZURES	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Nervous system disorders CONVULSION	0.20% 2/995	0.33% 1/301	0.00% 0/203	0.25% 5/2026	0.00% 0/824	0.00% 0/183
Nervous system disorders FEBRILE CONVULSION	0.10% 1/995	0.00% 0/301	0.49% 1/203	0.64% 13/2026	0.49% 4/824	0.55% 1/183
Nervous system disorders GRAND MAL CONVULSION	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Nervous system disorders PSYCHOMOTOR SKILLS IMPAIRED	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Nervous system disorders TONIC CONVULSION	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.24% 2/824	0.00% 0/183
Renal and urinary disorders NEPHROTIC SYNDROME	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders APNOEA	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders ASTHMA	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.30% 6/2026	0.36% 3/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders BRONCHIAL HYPERREACTIVITY	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.25% 5/2026	0.24% 2/824	0.55% 1/183
Respiratory, thoracic and mediastinal disorders CHOKING	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders FOREIGN BODY ASPIRATION	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders LARYNGOSPASM	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.00% 0/995	0.33% 1/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISORDER	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.10% 2/2026	0.00% 0/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders STATUS ASTHMATICUS	0.00% 0/995	0.00% 0/301	0.49% 1/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders TACHYPNOEA	0.00% 0/995	0.33% 1/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Respiratory, thoracic and mediastinal disorders WHEEZING	0.20% 2/995	0.00% 0/301	0.49% 1/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Skin and subcutaneous tissue disorders RASH	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.12% 1/824	0.00% 0/183
Surgical and medical procedures INTESTINAL OPERATION	0.00% 0/995	0.00% 0/301	0.00% 0/203	0.05% 1/2026	0.00% 0/824	0.00% 0/183
Vascular disorders KAWASAKI'S DISEASE	0.10% 1/995	0.00% 0/301	0.00% 0/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183

Other adverse events

Measure	US1+US3 n=995 participants at risk Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).	US2+US4A+US4B n=301 participants at risk Groups Infant Vaccines only (US2, US4A, and US4B) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received: 1. One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age ( US2 and US4A). 2. Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B)	US4C n=203 participants at risk US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.	LA1+LA3+LA5 n=2026 participants at risk Groups Men ACWY-CRM + Infant Vaccines (LA1, LA3 and LA5) pooled LA infants received MenACWY at 2 and 6 months of age; and DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received at 12 months of age pneumococcal conjugate vaccine, HAV, and MMR-V and concomitant third dose of MenACWY (LA1A) or a third dose of MenACWY at 13 months of age (LA1B). LA infants received MenACWY, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. At 12 months of age these infants received pneumococcal conjugate vaccine, HAV, and MMR-V and received: 1. Fourth dose of MenACWY concomitantly with DTaP and Hib at 16 months of age (LA3A) 2. DTaP and Hib at 16 months and fourth dose of MenACWY at 17 months of age (LA3B). 3. Concomitantly the fourth dose of MenACWY (LA5).	LA2+4+6AB n=824 participants at risk Groups Infant Vaccines only (LA2, LA4, LA6A and LA6B) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants either received: one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY at 15 months of age (LA2 and LA4) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B).	LA6C n=183 participants at risk LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Eye disorders CONJUNCTIVITIS	9.3% 93/995	10.0% 30/301	14.3% 29/203	3.4% 68/2026	3.4% 28/824	4.9% 9/183
Gastrointestinal disorders DIARRHOEA	29.0% 289/995	30.2% 91/301	38.4% 78/203	29.5% 597/2026	34.8% 287/824	31.1% 57/183
Gastrointestinal disorders FLATULENCE	2.3% 23/995	2.7% 8/301	5.9% 12/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	4.9% 49/995	3.7% 11/301	5.9% 12/203	2.6% 53/2026	3.5% 29/824	0.55% 1/183
Gastrointestinal disorders TEETHING	8.3% 83/995	9.3% 28/301	14.8% 30/203	0.54% 11/2026	0.24% 2/824	0.00% 0/183
Gastrointestinal disorders VOMITING	21.8% 217/995	22.9% 69/301	30.0% 61/203	24.0% 486/2026	27.7% 228/824	21.3% 39/183
General disorders INJECTION SITE ERYTHEMA	28.1% 280/995	35.9% 108/301	49.3% 100/203	61.5% 1245/2026	66.5% 548/824	63.9% 117/183
General disorders INJECTION SITE INDURATION	20.5% 204/995	33.6% 101/301	38.4% 78/203	36.8% 745/2026	40.4% 333/824	49.2% 90/183
General disorders INJECTION SITE PAIN	65.4% 651/995	65.1% 196/301	72.4% 147/203	78.6% 1592/2026	84.7% 698/824	89.6% 164/183
General disorders IRRITABILITY	80.4% 800/995	79.7% 240/301	84.2% 171/203	55.3% 1120/2026	57.5% 474/824	60.1% 110/183
General disorders MALAISE	0.00% 0/995	0.00% 0/301	0.00% 0/203	6.7% 136/2026	8.9% 73/824	2.7% 5/183
General disorders PYREXIA	29.7% 296/995	31.2% 94/301	36.5% 74/203	36.9% 748/2026	41.4% 341/824	40.4% 74/183
Infections and infestations BRONCHIOLITIS	10.9% 108/995	11.3% 34/301	12.3% 25/203	8.9% 180/2026	6.3% 52/824	19.7% 36/183
Infections and infestations BRONCHITIS	1.0% 10/995	2.0% 6/301	2.5% 5/203	10.8% 219/2026	11.5% 95/824	9.3% 17/183
Infections and infestations CROUP INFECTIOUS	4.4% 44/995	4.0% 12/301	7.4% 15/203	0.10% 2/2026	0.12% 1/824	0.00% 0/183
Infections and infestations GASTROENTERITIS	4.9% 49/995	6.0% 18/301	3.0% 6/203	2.4% 48/2026	4.2% 35/824	1.6% 3/183
Infections and infestations NASOPHARYNGITIS	4.1% 41/995	3.0% 9/301	5.4% 11/203	18.5% 375/2026	23.3% 192/824	14.8% 27/183
Infections and infestations OTITIS MEDIA	25.9% 258/995	25.2% 76/301	30.5% 62/203	1.3% 26/2026	2.1% 17/824	1.1% 2/183
Infections and infestations OTITIS MEDIA ACUTE	4.2% 42/995	5.0% 15/301	6.4% 13/203	1.8% 37/2026	1.8% 15/824	3.8% 7/183
Infections and infestations RESPIRATORY TRACT INFECTION	0.20% 2/995	0.00% 0/301	0.00% 0/203	8.0% 163/2026	8.6% 71/824	2.7% 5/183
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	34.2% 340/995	35.9% 108/301	36.5% 74/203	0.79% 16/2026	0.49% 4/824	0.00% 0/183
Infections and infestations VIRAL INFECTION	8.2% 82/995	7.3% 22/301	9.9% 20/203	2.2% 44/2026	3.4% 28/824	0.55% 1/183
Nervous system disorders CRYING	56.1% 558/995	51.2% 154/301	61.1% 124/203	45.8% 927/2026	50.8% 419/824	53.6% 98/183
Nervous system disorders SOMNOLENCE	67.9% 676/995	61.1% 184/301	69.5% 141/203	59.1% 1198/2026	62.3% 513/824	60.1% 110/183
Psychiatric disorders EATING DISORDERS	42.7% 425/995	40.5% 122/301	45.8% 93/203	30.0% 607/2026	31.9% 263/824	37.7% 69/183
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	1.5% 15/995	0.00% 0/301	1.5% 3/203	1.9% 38/2026	0.85% 7/824	8.2% 15/183
Respiratory, thoracic and mediastinal disorders COUGH	6.4% 64/995	6.6% 20/301	7.4% 15/203	2.0% 41/2026	2.9% 24/824	2.2% 4/183
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	6.0% 60/995	5.0% 15/301	8.9% 18/203	0.30% 6/2026	0.12% 1/824	0.55% 1/183
Skin and subcutaneous tissue disorders DERMATITIS ATOPIC	2.9% 29/995	3.0% 9/301	6.4% 13/203	1.3% 26/2026	1.9% 16/824	0.55% 1/183
Skin and subcutaneous tissue disorders DERMATITIS DIAPER	6.2% 62/995	7.0% 21/301	6.4% 13/203	0.39% 8/2026	0.49% 4/824	0.00% 0/183
Skin and subcutaneous tissue disorders ECZEMA	10.6% 105/995	10.6% 32/301	10.3% 21/203	0.00% 0/2026	0.00% 0/824	0.00% 0/183
Skin and subcutaneous tissue disorders RASH	15.5% 154/995	11.0% 33/301	19.2% 39/203	15.9% 323/2026	16.5% 136/824	17.5% 32/183

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

Restriction type: GT60