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

A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00474526

Enrollment

4545

Registered

2007-05-17

Start date

2007-03-31

Completion date

2009-11-30

Last updated

2014-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningitis, Meningococcal

Keywords

Meningococcal, meningitis, vaccine, infants, Meningococcal meningitis, Meningococcal disease

Brief summary

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

Interventions

BIOLOGICALMeningococcal ACWY Conjugate Vaccine

BIOLOGICALDTaP-IPV-HBV

BIOLOGICALHib

BIOLOGICALRotavirus

BIOLOGICALPneumococcal 7-valent Conjugate Vaccine

BIOLOGICALHAV

BIOLOGICALMMR-V

BIOLOGICALDTaP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Months to 2 Months

Healthy volunteers

Yes

Inclusion criteria

* Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.

Exclusion criteria

* Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	13 months of age (one month post-toddler vaccination)	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
Geometric Mean hSBA Titers - US Subjects	13 months of age (one month post-toddler vaccination)	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.

Secondary

Measure	Time frame	Description
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	7 days after vaccination	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.
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	7 days after vaccination	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.
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	7 days post vaccination	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.
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	7 days post vaccination	Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.
Geometric Mean hSBA Titers Post-infant Series - US Subjects	7 months of age (one month post-infant series)	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.
Geometric Mean hSBA Titers Post-infant Series - LA Subjects	7 months of age (one month post-infant series)	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.
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	7 months of age (one month post-infant series)	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.
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	7 months of age (one month post-infant series)	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.
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	7 months of age (one month post-infant series)	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) .
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	7 months of age (one month post-infant series)	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) .
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects	7 months of age (one month post-infant series)	Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects	7 months of age (one month post-infant series)	Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects	7 months of age (one month post-infant series)	Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects	7 months of age (one month post-infant series)	Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject	12 Months of Age (one month pre-toddler vaccination)	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.
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject	12 Months of Age (one month pre-toddler vaccination)	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.
Persistence Antibodies Geometric Mean Titers - US Subject	12 Months of Age (one month pre-toddler vaccination)	Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	12 or 16 Months of Age (one month pre-toddler vaccination)	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.
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	7 days after vaccination	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.
Persistence Antibodies Geometric Mean Titers - LA Subjects	12 or 16 Months of Age (one month pre-toddler vaccination)	Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects	13 months of age (one month post-toddler vaccination)	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.
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects	13 months of age (one month post-toddler vaccination)	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.
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects	13 months of age (one month post-toddler vaccination)	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.
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	13 months of age (one month post-toddler vaccination)	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.
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	13 or 17 Months of Age (one month post-toddler vaccination)	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.
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	13 or 17 Months of Age (one month post-toddler vaccination)	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.
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	13 or 17 Months of Age (one month post-toddler vaccination)	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.
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	13 or 17 Months of Age (one month post-toddler vaccination)	Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	13 months of age (one month post-toddler vaccination)	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.
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects	13 months of age (one month post-toddler vaccination)	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.
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects	13 months of age (one month post-toddler vaccination)	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.
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects	13 months of age (one month post-toddler vaccination)	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
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	17 months of age (one month post-toddler vaccination)	Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	17 months of age (one month post-toddler vaccination)	Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	12 or 15 months of age (one month post 1st or 2nd toddler vaccination)	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.
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	12 or 15 months of age (one month post 1st or 2nd toddler vaccination)	Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	12 or 16 Months of Age (one month pre-toddler vaccination)	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.
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	7 days after vaccination	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.

Countries

Argentina, Colombia, United States

Participant flow

Participants by arm

Arm	Count
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.	154
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.	166
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.	159
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.	680
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.	76
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.	70
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.	203
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.	151
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.	150
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.	148
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.	151
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.	150
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.	150
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.	1,426
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.	358
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.	170
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	183
TOTAL Total of all reporting groups	4,545
Total	9,090

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011	FG012	FG013	FG014	FG015	FG016
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

Characteristic	US1A (MenACWY-CRM + Infant Vaccines)	US1B (MenACWY-CRM + Infant Vaccines)	US2 (Infant Vaccines Only)	US3 (MenACWY-CRM + Infant Vaccines)	US4A (Infant Vaccines Only)	US4B (Infant Vaccines Only)	US4C (Infant Vaccines Only)	LA1A (MenACWY-CRM + Infant Vaccines)	LA1B (MenACWY-CRM + Infant Vaccines)	LA2 (Infant Vaccines Only)	LA3A (MenACWY-CRM + Infant Vaccines)	LA3B (MenACWY-CRM + Infant Vaccines)	LA4 (Infant Vaccines Only)	LA5 (MenACWY-CRM + Infant Vaccines)	LA6A (Infant Vaccines Only)	LA6B (Infant Vaccines Only)	LA6C (Infant Vaccines Only)	TOTAL
Age, Continuous	66.1 days STANDARD_DEVIATION 7.2	65.8 days STANDARD_DEVIATION 6.6	65.7 days STANDARD_DEVIATION 6.5	65.0 days STANDARD_DEVIATION 6	66.1 days STANDARD_DEVIATION 6.2	65.0 days STANDARD_DEVIATION 6.5	65.9 days STANDARD_DEVIATION 6.5	68.0 days STANDARD_DEVIATION 7.7	68.6 days STANDARD_DEVIATION 8.9	67.8 days STANDARD_DEVIATION 8.3	67.0 days STANDARD_DEVIATION 7.9	68.4 days STANDARD_DEVIATION 8.7	67.5 days STANDARD_DEVIATION 8	65.0 days STANDARD_DEVIATION 9.4	67.7 days STANDARD_DEVIATION 9.7	59.5 days STANDARD_DEVIATION 6.2	65.0 days STANDARD_DEVIATION 7.9	65.7 days STANDARD_DEVIATION 8.3
Sex: Female, Male Female	68 Participants	72 Participants	71 Participants	340 Participants	39 Participants	29 Participants	103 Participants	79 Participants	82 Participants	72 Participants	72 Participants	75 Participants	81 Participants	682 Participants	178 Participants	89 Participants	91 Participants	2223 Participants
Sex: Female, Male Male	86 Participants	94 Participants	88 Participants	340 Participants	37 Participants	41 Participants	100 Participants	72 Participants	68 Participants	76 Participants	79 Participants	75 Participants	69 Participants	744 Participants	180 Participants	81 Participants	92 Participants	2322 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	957 / 995	279 / 301	202 / 203	1,946 / 2,026	795 / 824	178 / 183
serious Total, serious adverse events	58 / 995	18 / 301	14 / 203	173 / 2,026	84 / 824	12 / 183

Outcome results

Primary

Geometric Mean hSBA Titers - US Subjects

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.

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers - US Subjects	A Pre-vaccination (84, 74)	2.51 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers - US Subjects	A Post-vaccination (84, 74)	77 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers - US Subjects	C Pre-vaccination (86, 73)	7.72 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers - US Subjects	C Post-vaccination (86, 73)	227 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers - US Subjects	W Pre-vaccination (85, 73)	14 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers - US Subjects	W Post-vaccination (85, 73)	416 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers - US Subjects	Y Pre-vaccination (84, 68)	11 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers - US Subjects	Y Post-vaccination (84, 68)	395 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers - US Subjects	Y Post-vaccination (84, 68)	10 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers - US Subjects	A Pre-vaccination (84, 74)	2.14 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers - US Subjects	W Pre-vaccination (85, 73)	2.21 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers - US Subjects	A Post-vaccination (84, 74)	17 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers - US Subjects	Y Pre-vaccination (84, 68)	2.14 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers - US Subjects	C Pre-vaccination (86, 73)	2.26 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers - US Subjects	W Post-vaccination (85, 73)	11 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers - US Subjects	C Post-vaccination (86, 73)	35 Titers

Comparison: Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.95% CI: [3.04, 6.74]ANOVA

Primary

Percentage of Subjects With hSBA Titer >=1:8 - US Subjects

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

Time frame: 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

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	A (84, 74)	94 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	C (86, 73)	98 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	W (85, 73)	100 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	Y (84, 68)	100 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	Y (84, 68)	56 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	A (84, 74)	72 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	W (85, 73)	58 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	C (86, 73)	90 Percentages of subjects

Secondary

Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects

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.

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

Population: Per Protocol

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	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)
US1A (MenACWY- CRM + Infant Vaccines)	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)
US1A (MenACWY- CRM + Infant Vaccines)	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)
US1A (MenACWY- CRM + Infant Vaccines)	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)
US1A (MenACWY- CRM + Infant Vaccines)	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)
US1A (MenACWY- CRM + Infant Vaccines)	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)
US1A (MenACWY- CRM + Infant Vaccines)	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)
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects	PnC 23F (N=97, N=97)	5.92 Concentrations (μg/mL)
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects	PnC 4 (N=97, N=97)	4.02 Concentrations (μg/mL)
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects	PnC 6B (N=96, N=97)	5.61 Concentrations (μg/mL)
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects	PnC 9V (N=97, N=97)	3.77 Concentrations (μg/mL)
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects	PnC 14(N=97, N=97)	14 Concentrations (μg/mL)
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects	PnC 18C (N=97, N=97)	2.77 Concentrations (μg/mL)
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects	PnC 19F (N=97, N=97)	4.26 Concentrations (μg/mL)

Comparison: PnC 4 (Post-vaccination GMC; group ratio LA1A:LA1B)95% CI: [0.61, 1.02]ANOVA

Comparison: PnC 6B (Post-vaccination GMC; group ratio LA1A:LA1B)95% CI: [0.54, 1.2]ANOVA

Comparison: PnC 9V (Post-vaccination GMC; group ratio LA1A:LA1B)95% CI: [0.58, 0.94]ANOVA

Comparison: PnC 14 (Post-vaccination GMC; group ratio LA1A:LA1B)95% CI: [0.51, 0.82]ANOVA

Comparison: PnC 18C (Post-vaccination GMC; group ratio LA1A:LA1B)95% CI: [0.6, 1.01]ANOVA

Comparison: PnC 19F (Post-vaccination GMC; group ratio LA1A:LA1B)95% CI: [0.56, 1.04]ANOVA

Comparison: PnC 23F (Post-vaccination GMC; group ratio LA1A:LA1B)95% CI: [0.54, 1.01]ANOVA

Secondary

Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects

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.

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

Population: Per Protocol

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 9V (N=86, N=99)	2.8 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 18C (N=87, N=98)	2.76 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 6B (N=86, N=99)	6.82 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 19F(N=86, N=99)	3.63 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 14 (N=86, N=99)	12 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 23F (N=87, N=99)	5.31 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 4 (N=86, N=99)	2.9 Titers
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 23F (N=87, N=99)	5.63 Titers
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 4 (N=86, N=99)	3.24 Titers
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 6B (N=86, N=99)	8.58 Titers
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 9V (N=86, N=99)	3.13 Titers
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 14 (N=86, N=99)	15 Titers
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 18C (N=87, N=98)	2.71 Titers
US2 (Infant Vaccine Only)	Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	PnC 19F(N=86, N=99)	3.48 Titers

Comparison: PnC 4 (Post-vaccination GMC; group ratio US1A:US1B)95% CI: [0.67, 1.2]ANOVA

Comparison: PnC 6B (Post-vaccination GMC; group ratio US1A:US1B)95% CI: [0.62, 1.02]ANOVA

Comparison: PnC 9V (Post-vaccination GMC; group ratio US1A:US1B)95% CI: [0.67, 1.2]ANOVA

Comparison: PnC 14 (Post-vaccination GMC; group ratio US1A:US1B)95% CI: [0.63, 1.03]ANOVA

Comparison: PnC 18C (Post-vaccination GMC; group ratio US1A:US1B)95% CI: [0.78, 1.34]ANOVA

Comparison: PnC 19F (Post-vaccination GMC; group ratio US1A:US1B)95% CI: [0.81, 1.34]ANOVA

Comparison: PnC 23F (Post-vaccination GMC; group ratio US1A:US1B)95% CI: [0.69, 1.29]ANOVA

Secondary

Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects

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

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

Population: Per Protocol

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	Pertactin (N=113, N=99)	197 Titers
US2 (Infant Vaccine Only)	Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	Diphtheria (N=118, N=101)	5.16 Titers
US2 (Infant Vaccine Only)	Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	FHA (N=113, N=99)	215 Titers
US2 (Infant Vaccine Only)	Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	Tetanus (N=118, N=101)	6.58 Titers
US2 (Infant Vaccine Only)	Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	Hib (N=117, N=101)	41 Titers
US2 (Infant Vaccine Only)	Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	PT (N=113, N=99)	62 Titers

Comparison: Diphtheria (Post-vaccination GMC; group ratio LA3A:LA3B)95% CI: [0.86, 1.27]ANOVA

Comparison: Tetanus (Post-vaccination GMC; group ratio LA3A:LA3B)95% CI: [0.75, 1.18]ANOVA

Comparison: PT (Post-vaccination GMC; group ratio LA3A:LA3B)95% CI: [0.88, 1.4]ANOVA

Comparison: FHA (Post-vaccination GMC; group ratio LA3A:LA3B)95% CI: [0.9, 1.44]ANOVA

Comparison: Pertactin (Post-vaccination GMC; group ratio LA3A:LA3B95% CI: [0.92, 1.59]ANOVA

Comparison: Hib (Post-vaccination GMC; group ratio LA3A:LA3B)95% CI: [0.63, 1.16]ANOVA

Secondary

Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects

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

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

Population: Per Protocol

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	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)	2045 Titers
US2 (Infant Vaccine Only)	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)	2.21 Titers
US2 (Infant Vaccine Only)	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)	6.01 Titers
US2 (Infant Vaccine Only)	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)	2.46 Titers
US2 (Infant Vaccine Only)	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)	2.24 Titers
US2 (Infant Vaccine Only)	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)	2.21 Titers
US2 (Infant Vaccine Only)	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)	2.6 Titers
US2 (Infant Vaccine Only)	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)	97 Titers
US2 (Infant Vaccine Only)	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)	124 Titers
US2 (Infant Vaccine Only)	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)	2.19 Titers
US2 (Infant Vaccine Only)	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)	2.09 Titers
US2 (Infant Vaccine Only)	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)	598 Titers
US2 (Infant Vaccine Only)	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)	1.54 Titers
US2 (Infant Vaccine Only)	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)	366 Titers
US2 (Infant Vaccine Only)	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)	8.06 Titers
US2 (Infant Vaccine Only)	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)	747 Titers
US2 (Infant Vaccine Only)	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)	45 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	1.91 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	1.45 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	2.51 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	45 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	99 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	119 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	533 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	318 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	656 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	1900 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	7.19 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	2.09 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	1.81 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	7.69 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	1.7 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	2.3 Titers
US1 (MenACWY-CRM + Infant Vaccines)	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)	2.12 Titers
US2 (Infant Vaccines Only)	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)	2.19 Titers
US2 (Infant Vaccines Only)	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)	813 Titers
US2 (Infant Vaccines Only)	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)	385 Titers
US2 (Infant Vaccines Only)	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)	2.65 Titers
US2 (Infant Vaccines Only)	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)	9.18 Titers
US2 (Infant Vaccines Only)	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)	684 Titers
US2 (Infant Vaccines Only)	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)	149 Titers
US2 (Infant Vaccines Only)	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)	1.77 Titers
US2 (Infant Vaccines Only)	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)	2.26 Titers
US2 (Infant Vaccines Only)	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)	112 Titers
US2 (Infant Vaccines Only)	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)	49 Titers
US2 (Infant Vaccines Only)	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)	2.39 Titers
US2 (Infant Vaccines Only)	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)	2.42 Titers
US2 (Infant Vaccines Only)	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)	2.4 Titers
US2 (Infant Vaccines Only)	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)	6.74 Titers
US2 (Infant Vaccines Only)	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)	1993 Titers
US2 (Infant Vaccines Only)	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)	2.53 Titers

Comparison: Diphtheria (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.96, 1.4]ANOVA

Comparison: Tetanus (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.96, 1.27]ANOVA

Comparison: PT (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.87, 1.25]ANOVA

Comparison: FHA (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.89, 1.23]ANOVA

Comparison: Pertactin (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.81, 1.21]ANOVA

Comparison: Polio Type 1 (Post-vaccination GMT; group ratio LA1:LA2)95% CI: [0.68, 1.17]ANOVA

Comparison: Polio Type 2 (Post-vaccination GMT; group ratio LA1:LA2)95% CI: [0.73, 1.28]ANOVA

Comparison: Polio Type 3 (Post-vaccination GMT; group ratio LA1:LA2)95% CI: [0.69, 1.31]ANOVA

Comparison: Hepatitis B (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.88, 1.4]ANOVA

Comparison: HIb (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.98, 1.65]ANOVA

Comparison: PnC 4 (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.78, 1.09]ANOVA

Comparison: PnC 6B (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.74, 1.27]ANOVA

Comparison: PnC 9V (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.71, 1.04]ANOVA

Comparison: PnC 14 (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.72, 1.14]ANOVA

Comparison: PnC 18C (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.74, 1.08]ANOVA

Comparison: PnC 19F (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.74, 1.1]ANOVA

Comparison: PnC 23F (Post-vaccination GMC; group ratio LA1:LA2)95% CI: [0.6, 0.99]ANOVA

Comparison: Diphtheria (Post-vaccination GMC; group ratio LA3:LA4)95% CI: [0.69, 0.99]ANOVA

Comparison: Tetanus (Post-vaccination GMC; group ratio LA3:LA4)95% CI: [0.83, 1.09]ANOVA

Comparison: PT (Post-vaccination GMC; group ratio LA3:LA4)95% CI: [0.78, 1.1]ANOVA

Comparison: FHA (Post-vaccination GMC; group ratio LA3:LA4)95% CI: [0.75, 1.03]ANOVA

Comparison: Pertactin (Post-vaccination GMC; group ratio LA3:LA495% CI: [0.66, 0.97]ANOVA

Comparison: Polio Type 1 (Post-vaccination GMT; group ratio LA3:LA4)95% CI: [0.6, 1.02]ANOVA

Comparison: Polio Type 2 (Post-vaccination GMT; group ratio LA3:LA4)95% CI: [0.63, 1.09]ANOVA

Comparison: Polio Type 3 (Post-vaccination GMT; group ratio LA3:LA4)95% CI: [0.59, 1.11]ANOVA

Comparison: Hepatitis B (Post-vaccination GMT; group ratio LA3:LA4)95% CI: [0.76, 1.19]ANOVA

Comparison: HIb (Post-vaccination GMC; group ratio LA3:LA4)95% CI: [0.83, 1.37]ANOVA

Comparison: PnC 4 (Post-vaccination GMT; group ratio LA3:LA4)95% CI: [0.68, 0.95]ANOVA

Comparison: PnC 6B (Post-vaccination GMC; group ratio LA3:LA4)95% CI: [0.67, 1.14]ANOVA

Comparison: PnC 9V (Post-vaccination GMC; group ratio LA3:LA4)95% CI: [0.69, 1]ANOVA

Comparison: PnC 14 (Post-vaccination GMC; group ratio LA3:LA4)95% CI: [0.67, 1.05]ANOVA

Comparison: PnC 18C (Post-vaccination GMC; group ratio LA3:LA4)95% CI: [0.62, 0.9]ANOVA

Comparison: PnC 19F (Post-vaccination GMC; group ratio LA3:LA4)95% CI: [0.75, 1.1]ANOVA

Comparison: PnC 23F (Post-vaccination GMC; group ratio LA3:LA4)95% CI: [0.69, 1.12]ANOVA

Secondary

Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects

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

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

Population: Per Protocol

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	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)	2.15 Titers
US2 (Infant Vaccine Only)	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)	2.88 Titers
US2 (Infant Vaccine Only)	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)	2.31 Titers
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	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)	114 Titers
US2 (Infant Vaccine Only)	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)	110 Titers
US2 (Infant Vaccine Only)	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)	441 Titers
US2 (Infant Vaccine Only)	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)	290 Titers
US2 (Infant Vaccine Only)	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)	635 Titers
US2 (Infant Vaccine Only)	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)	2112 Titers
US2 (Infant Vaccine Only)	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)	3.56 Titers
US2 (Infant Vaccine Only)	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)	2 Titers
US2 (Infant Vaccine Only)	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)	2.55 Titers
US2 (Infant Vaccine Only)	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)	2.15 Titers
US2 (Infant Vaccine Only)	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)	6.79 Titers
US2 (Infant Vaccine Only)	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)	2.54 Titers
US2 (Infant Vaccine Only)	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)	2.73 Titers

Comparison: Diphtheria (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.74, 1.04]ANOVA

Comparison: Tetanus (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.92, 1.28]ANOVA

Comparison: PT (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.79, 1.26]ANOVA

Comparison: FHA (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.85, 1.25]

Comparison: Pertactin (Post-vaccination GMT; group ratio US1:US295% CI: [0.83, 1.32]ANOVA

Comparison: Polio Type 1 (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.75, 1.23]ANOVA

Comparison: Polio Type 2 (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.93, 1.55]ANOVA

Comparison: Polio Type 3 (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.85, 1.56]ANOVA

Comparison: Hepatitis B (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.65, 1.2]ANOVA

Comparison: HIb (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.97, 1.77]ANOVA

Comparison: PnC 4 (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.7, 1]ANOVA

Comparison: PnC 6B (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.56, 1.03]ANOVA

Comparison: PnC 9V (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.7, 1.04]ANOVA

Comparison: PnC 14 (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.84, 1.26]ANOVA

Comparison: PnC 18C (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.64, 0.93]ANOVA

Comparison: PnC 19F (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.69, 0.97]ANOVA

Comparison: PnC 23F (Post-vaccination GMT; group ratio US1:US2)95% CI: [0.62, 1.02]ANOVA

Secondary

Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects

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

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	Y Post-vaccination (71, 95)	329 Titers
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	W Pre-vaccination (70, 98)	2.33 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	A Post-vaccination (78, 101)	128 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	Y Pre-vaccination (71, 95)	2.04 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	C Pre-vaccination (78, 102)	2.05 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	W Post-vaccination (70, 98)	394 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	C Post-vaccination (78, 102)	501 Titers

Secondary

Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects

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

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	A Pre-vaccination (103, 120)	3.83 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	A Post-vaccination (103, 120)	112 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	C Pre-vaccination (102, 122)	11 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	C Post-vaccination (102, 122)	279 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	W Pre-vaccination (98, 112)	28 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	W Post-vaccination (98, 112)	762 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	Y Pre-vaccination (98, 109)	16 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	Y Post-vaccination (98, 109)	550 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	Y Post-vaccination (98, 109)	590 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	A Pre-vaccination (103, 120)	2.95 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	W Pre-vaccination (98, 112)	13 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	A Post-vaccination (103, 120)	146 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	Y Pre-vaccination (98, 109)	8.1 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	C Pre-vaccination (102, 122)	3.83 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	W Post-vaccination (98, 112)	727 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	C Post-vaccination (102, 122)	283 Titers

Secondary

Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	A Pre-vaccination (84, 74)	2.51 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	A Post-vaccination (84, 74)	77 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	C Pre-vaccination (86, 73)	7.72 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	C Post-vaccination (86, 73)	227 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	W Pre-vaccination (85, 73)	14 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	W Post-vaccination (85, 73)	416 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	Y Pre-vaccination (84, 68)	11 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	Y Post-vaccination (84, 68)	395 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	Y Post-vaccination (84, 68)	10 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	A Pre-vaccination (84, 74)	2.14 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	W Pre-vaccination (85, 73)	2.21 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	A Post-vaccination (84, 74)	17 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	Y Pre-vaccination (84, 68)	2.14 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	C Pre-vaccination (86, 73)	2.26 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	W Post-vaccination (85, 73)	11 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	C Post-vaccination (86, 73)	35 Titers

Secondary

Geometric Mean hSBA Titers Post-infant Series - LA Subjects

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.

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

Population: Per protocol population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	A (Pre-vaccination GMT; N= 272, 271)	2.09 Titer
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	A (Post-vaccination GMT; N= 277, 268)	31 Titer
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	C (Pre-vaccination GMT; N= 273,272)	2.32 Titer
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	C (Post-vaccination GMT; N= 277, 272)	155 Titer
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	W (Pre-vaccination GMT; N= 263, 261)	2.9 Titer
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	W (Post-vaccination GMT; N=271,264)	259 Titer
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	Y (Pre-vaccination GMT; N=258, 260)	2.35 Titer
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	Y (Post-vaccination GMT; N=272,263)	159 Titer
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	Y (Post-vaccination GMT; N=272,263)	125 Titer
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	A (Pre-vaccination GMT; N= 272, 271)	2.03 Titer
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	W (Pre-vaccination GMT; N= 263, 261)	2.54 Titer
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	A (Post-vaccination GMT; N= 277, 268)	43 Titer
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	Y (Pre-vaccination GMT; N=258, 260)	2.26 Titer
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	C (Pre-vaccination GMT; N= 273,272)	2.34 Titer
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	W (Post-vaccination GMT; N=271,264)	182 Titer
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - LA Subjects	C (Post-vaccination GMT; N= 277, 272)	150 Titer

Comparison: Serogroup A (Post-vaccination GMT; group ratio LA1:LA3)95% CI: [0.55, 0.95]ANOVA

Comparison: Serogroup C (Post-vaccination GMT; group ratio LA1:LA3)95% CI: [0.81, 1.31]ANOVA

Comparison: Serogroup W (Post-vaccination GMT; group ratio LA1:LA3)95% CI: [1.18, 1.72]ANOVA

Comparison: Serogroup Y (Post-vaccination GMT; group ratio LA1:LA3)95% CI: [1.02, 1.58]ANOVA

Secondary

Geometric Mean hSBA Titers Post-infant Series - US Subjects

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.

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	A (Pre-vaccination GMT; N= 177, 65)	2.11 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	A (Post-vaccination GMT; N= 212, 80)	13 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	C (Pre-vaccination GMT; N= 168, 64)	2.48 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	C (Post-vaccination GMT; N= 204, 84)	108 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	W (Pre-vaccination GMT; N= 165, 66)	3.07 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	W (Post-vaccination GMT; N=197, 90)	100 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	Y (Pre-vaccination GMT; N=150, 62 )	2.53 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	Y (Post-vaccination GMT; N=182, 84)	73 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	Y (Post-vaccination GMT; N=182, 84)	2.03 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	A (Pre-vaccination GMT; N= 177, 65)	2.1 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	W (Pre-vaccination GMT; N= 165, 66)	2.71 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	A (Post-vaccination GMT; N= 212, 80)	2.03 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	Y (Pre-vaccination GMT; N=150, 62 )	2.13 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	C (Pre-vaccination GMT; N= 168, 64)	2.17 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	W (Post-vaccination GMT; N=197, 90)	2.08 Titers
US2 (Infant Vaccine Only)	Geometric Mean hSBA Titers Post-infant Series - US Subjects	C (Post-vaccination GMT; N= 204, 84)	2.12 Titers

Secondary

Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age

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.

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Any	10 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Any	5 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Any	38 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Any	11 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Any	28 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Any	8 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Any	6 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Body Temp. ( >= 38° C )	14 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Any	21 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Severe	2 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Any	21 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Analgesic / Antipyretic medication used	60 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Any	53 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Severe	2 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Any	31 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Any	21 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Any	53 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Any	4 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Any	17 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Any	4 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Any	29 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Analgesic / Antipyretic medication used	56 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Any	13 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Any	16 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Severe	2 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Any	14 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Body Temp. ( >= 38° C )	10 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Any	44 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Severe	3 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Any	149 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Severe	8 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Severe	3 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Any	177 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Any	31 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Severe	6 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Any	101 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Analgesic / Antipyretic medication used	320 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Severe	4 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Any	120 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Any	271 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Severe	7 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Any	61 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Body Temp. ( >= 38° C )	49 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Any	81 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Any	27 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Any	12 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Severe	4 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Any	62 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Any	16 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Any	18 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Severe	3 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Any	8 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Any	5 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Body Temp. ( >= 38° C )	12 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Analgesic / Antipyretic medication used	78 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Any	20 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Any	24 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Any	22 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Any	38 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Severe	2 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Any	70 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Severe	2 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Any	34 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Severe	0 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Any	149 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Severe	2 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Body Temp. ( >= 38° C )	35 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Any	80 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Severe	6 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Any	56 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Severe	4 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Any	218 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Severe	6 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Any	99 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Severe	6 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Any	23 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Any	111 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Severe	3 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Any	21 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Severe	1 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Analgesic / Antipyretic medication used	260 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Any	55 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Any	49 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Body Temp. ( >= 38° C )	20 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Any	11 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Any	14 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Severe	3 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Any	39 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Any	50 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Severe	0 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Any	29 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Severe	3 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Any	12 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Any	103 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Analgesic / Antipyretic medication used	120 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Any	75 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Analgesic / Antipyretic medication used	48 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Any	10 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Any	29 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Body Temp. ( >= 38° C )	16 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Any	36 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Any	7 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Severe	6 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Any	35 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Any	3 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Severe	2 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Any	18 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Any	32 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Any	3 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Any	9 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Any	32 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Any	28 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Any	15 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Any	5 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Any	10 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Any	33 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Any	11 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Body Temp. ( >= 38° C )	12 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Any	23 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Severe	2 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Any	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Any	12 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Severe	2 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Analgesic / Antipyretic medication used	43 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Severe	2 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Any	56 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Any	51 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Severe	5 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Any	20 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Severe	2 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Body Temp. ( >= 38° C )	84 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Any	52 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Severe	4 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Severe	8 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Severe	0 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Any	72 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Any	81 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Any	184 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Severe	5 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Severe	3 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Any	130 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Analgesic / Antipyretic medication used	204 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Any	166 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Any	35 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Any	138 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Severe	4 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Any	289 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Severe	5 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Any	82 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Any	134 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Body Temp. ( >= 38° C )	188 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Analgesic / Antipyretic medication used	406 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Severe	8 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Any	309 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Severe	3 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Any	65 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Severe	36 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Severe	2 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Any	84 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Any	392 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Severe	7 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Any	123 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Severe	3 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Any	211 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Severe	0 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Irritability - Any	74 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Any	100 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Analgesic / Antipyretic medication used	87 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Severe	0 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Severe	0 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Any	17 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Severe	0 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Body Temp. ( >= 38° C )	40 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Rash - Severe	10 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Induration (mm) - Any	43 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Severe	1 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Any	53 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Severe	0 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Severe	0 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Change in Eating Habits - Any	46 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Sleepiness - Severe	2 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Diarrhea - Any	37 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Vomiting - Any	12 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Erythema (mm) - Any	67 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Persistent Crying - Any	28 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	Tenderness - Severe	3 Subjects

Secondary

Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series

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.

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	105 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	42 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	64 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	6 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	10 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	82 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	3 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	3 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	2 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	83 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	6 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	10 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	2 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	13 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	24 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	43 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	15 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	23 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	18 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	4 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	46 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	74 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	2 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	4 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	76 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	2 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	6 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	9 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	107 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	104 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	14 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	17 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	120 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	3 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	189 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	3 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	117 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	140 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	7 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	27 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	19 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	225 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	88 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	33 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	5 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	47 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	187 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	24 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	7 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	15 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	8 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	7 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	3 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	49 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	6 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	2 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	110 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	76 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	69 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	23 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	96 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	4 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	14 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	17 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	34 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	5 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	25 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	5 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	32 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	324 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	107 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	447 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	354 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	66 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	25 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	11 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	3 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	4 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	16 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	24 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	419 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	67 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	252 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	171 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	8 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	61 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	14 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	211 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	161 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	19 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	21 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	96 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	2 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	46 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	12 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	125 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	8 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	11 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	3 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	173 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	3 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	36 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	223 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	54 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	4 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	44 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	25 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	121 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	8 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	7 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	95 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	11 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	155 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	15 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	2 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	7 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	5 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	154 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	42 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	74 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	106 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	86 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	30 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	37 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	20 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	9 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	56 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	2 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	53 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	62 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	96 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	6 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	62 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	19 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	75 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	3 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	2 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	2 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	12 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	30 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	53 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	18 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	11 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	99 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	12 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	4 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	44 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	93 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	6 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	72 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	29 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	44 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	159 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	22 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	86 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	170 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	87 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	4 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	1 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	22 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	80 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	16 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	59 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	20 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	95 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	2 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	65 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	43 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	1 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	4 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	52 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	1 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	4 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	8 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	17 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	1 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	5 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	53 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	916 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	215 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	2 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	727 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	211 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	222 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	2 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	54 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	92 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	249 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	508 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	996 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	2 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	98 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	542 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	479 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	29 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	1 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	21 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	6 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	250 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	22 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	2 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	510 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	21 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	127 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	258 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	74 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	4 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	4 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	26 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	2 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	96 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	100 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	14 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	126 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	97 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	1 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	273 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	501 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	55 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	240 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	381 Subjects

Secondary

Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series

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

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	32 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	608 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	51 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	100 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	5 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	154 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	259 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	85 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	10 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	672 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	19 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	541 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	11 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	31 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	464 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	93 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	14 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	369 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	32 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	50 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	77 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	6 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	69 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	230 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	25 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	28 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	130 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	3 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	63 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	2 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	307 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	16 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	174 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	13 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	16 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	6 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	249 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	3 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	333 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	58 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	1086 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	3 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	628 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	820 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	40 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	321 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	1155 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	27 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	607 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	294 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	114 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	6 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	110 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	566 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	266 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	229 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	244 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	3 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	26 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Severe	2 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Any	117 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Any	299 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Irritability - Severe	4 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Any	596 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Analgesic / Antipyretic medication used	590 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Any	301 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Persistent Crying - Severe	29 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Vomiting - Severe	2 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Any	59 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Any	338 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Rash - Severe	27 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Induration (mm) - Any	179 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Any	433 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Any	143 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Sleepiness - Severe	18 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Change in Eating Habits - Severe	5 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Body Temp. ( >= 38° C )	102 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Erythema (mm) - Severe	5 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Diarrhea - Any	118 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	Tenderness - Severe	94 Subjects

Secondary

Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series

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.

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	39 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	25 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	37 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	5 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	9 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	16 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	16 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	7 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	2 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	8 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	2 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	44 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	6 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	120 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	3 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	8 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	149 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	271 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	4 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	3 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	61 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	27 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	7 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	101 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	31 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	49 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	320 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	2 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	81 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	177 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	18 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	20 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	62 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	22 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	5 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	77 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	12 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	12 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	38 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	8 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	4 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	3 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	16 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	24 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	5 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	9 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	2 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	2 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	5 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	10 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	16 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	3 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	10 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	17 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	6 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	2 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	1 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	5 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	14 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	1 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	38 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	0 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	52 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	13 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	6 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	28 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	1 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	1 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	21 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	2 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	1 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	1 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	5 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	17 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	0 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	14 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	45 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	18 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	3 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	2 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	0 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	3 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	48 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	36 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	0 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	32 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	0 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	35 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	6 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	16 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	10 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	9 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	0 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	29 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	7 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	5 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	5 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	15 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	3 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	4 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	9 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	4 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	17 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	10 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	21 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	51 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	166 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	5 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	81 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	2 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	184 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	204 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	52 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	2 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	3 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	20 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	84 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	5 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	56 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	35 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	8 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	4 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	72 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	130 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	36 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	0 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	8 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	4 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	2 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	0 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	20 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	0 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	4 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	6 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	13 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	0 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	2 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	36 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	2 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	6 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	33 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	1 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	18 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	9 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	2 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	16 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	3 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	1 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	6 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	7 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	5 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	2 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	8 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	1 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	19 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	2 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	1 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	84 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	309 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	134 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	0 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	406 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	392 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	8 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	4 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	188 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	82 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	138 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	5 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	3 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	123 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	211 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	2 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	7 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	289 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	36 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	3 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	65 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	0 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	1 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	2 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	0 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	0 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	0 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	9 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	4 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	25 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	0 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	1 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	5 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	34 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	9 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	14 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	7 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	24 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	1 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	0 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	14 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	6 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	0 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Severe	1 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Any	12 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Severe	0 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Any	28 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Severe	0 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Severe	1 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Change in Eating Habits - Any	17 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Any	3 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Body Temp. ( >= 38° C )	8 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Any	52 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Irritability - Severe	0 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Rash - Any	2 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Any	35 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Severe	5 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Persistent Crying - Any	15 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Tenderness - Any	45 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Erythema (mm) - Severe	7 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Analgesic / Antipyretic medication used	34 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Induration (mm) - Severe	5 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Diarrhea - Severe	0 Subjects
LA6C (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	Sleepiness - Any	20 Subjects

Secondary

Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series

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.

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	59 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	69 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	2 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	8 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	42 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	25 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	16 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	83 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	17 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	3 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	14 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	94 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	3 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	16 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	10 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	16 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	9 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	19 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	56 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	59 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	5 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	6 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	41 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	21 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	91 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	80 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	83 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	8 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	46 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	33 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	17 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	26 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	125 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	23 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	4 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	32 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	185 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	118 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	163 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	56 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	4 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	7 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	83 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	2 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	11 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	15 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	34 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	20 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	35 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	47 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	27 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	3 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	96 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	13 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	75 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	45 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	230 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	49 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	122 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	3 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	53 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	342 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	14 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	178 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	5 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	24 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	6 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	238 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	3 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	49 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	385 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	60 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	11 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	4 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	107 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	28 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	182 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	2 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	2 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	27 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	48 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	2 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	3 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	131 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	9 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	35 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	201 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	4 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	137 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	64 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	13 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	42 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	3 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	82 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	28 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	3 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	23 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	92 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	4 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	13 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	13 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	115 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	5 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	62 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	131 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	4 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	73 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	20 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	28 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	2 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	26 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	5 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	12 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	10 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	36 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	13 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	61 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	41 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	45 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	22 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	14 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	59 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	223 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	97 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	726 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	149 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	13 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	52 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	583 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	4 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	485 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	194 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	160 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	13 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	3 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	136 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	414 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	294 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	6 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	49 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	857 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	14 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	430 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	75 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	237 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	401 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	10 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	187 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	311 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	5 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	45 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	46 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	122 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	7 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	29 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	90 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	90 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	5 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	209 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	126 Subjects

Secondary

Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series

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

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	16 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	505 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	72 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	3 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	2 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	79 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	168 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	77 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	3 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	363 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	108 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	10 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	32 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	348 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	570 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	5 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	261 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	14 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	66 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	5 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	95 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	2 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	75 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	3 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	193 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	13 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	43 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	84 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	46 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	3 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	265 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	12 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	141 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	4 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	17 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	178 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	3 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	34 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	297 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	57 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	16 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	267 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	841 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	547 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	988 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	18 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	675 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	17 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	156 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	188 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	62 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	9 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	4 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	110 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	177 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	496 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	246 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	5 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	336 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Any	250 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Any	85 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Irritability - Severe	5 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Any	460 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Any	356 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Any	209 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Persistent Crying - Severe	11 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Any	48 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Induration (mm) - Any	162 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Rash - Severe	30 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Any	263 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Any	102 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Sleepiness - Severe	8 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Change in Eating Habits - Severe	5 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Body Temp. ( >= 38° C )	135 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Diarrhea - Any	104 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Analgesic / Antipyretic medication used	491 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	Tenderness - Severe	50 Subjects

Secondary

Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series

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

Time frame: 7 days post vaccination

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Irritability - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Irritability - Any	31 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Body Temp. ( >= 38° C )	5 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Sleepiness - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Diarrhea - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Diarrhea - Any	4 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Change in Eating Habits - Any	7 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Induration (mm) - Any	10 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Change in Eating Habits - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Sleepiness - Any	12 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Erythema (mm) - Any	14 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Induration (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Erythema (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Rash - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Rash - Any	4 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Tenderness - Any	19 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Analgesic / Antipyretic medication used	40 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Persistent Crying - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Persistent Crying - Any	9 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Tenderness - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Vomiting - Any	5 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Rash - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Erythema (mm) - Any	6 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Erythema (mm) - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Induration (mm) - Any	2 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Induration (mm) - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Tenderness - Any	16 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Tenderness - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Body Temp. ( >= 38° C )	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Change in Eating Habits - Any	2 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Change in Eating Habits - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Diarrhea - Any	3 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Diarrhea - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Irritability - Any	22 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Irritability - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Persistent Crying - Any	10 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Persistent Crying - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Rash - Any	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Sleepiness - Any	8 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Sleepiness - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Vomiting - Any	2 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Analgesic / Antipyretic medication used	14 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Rash - Severe	4 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Irritability - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Induration (mm) - Any	51 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Tenderness - Any	128 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Sleepiness - Any	36 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Analgesic / Antipyretic medication used	85 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Persistent Crying - Severe	3 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Erythema (mm) - Any	143 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Sleepiness - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Vomiting - Any	12 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Change in Eating Habits - Any	18 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Tenderness - Severe	5 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Change in Eating Habits - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Rash - Any	9 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Erythema (mm) - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Diarrhea - Any	28 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Irritability - Any	71 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Body Temp. ( >= 38° C )	30 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Induration (mm) - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Diarrhea - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Persistent Crying - Any	37 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Diarrhea - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Irritability - Any	32 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Vomiting - Any	7 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Irritability - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Tenderness - Any	33 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Erythema (mm) - Any	28 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Persistent Crying - Any	6 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Persistent Crying - Severe	2 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Induration (mm) - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Rash - Any	3 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Induration (mm) - Any	2 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Rash - Severe	3 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Vomiting - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Sleepiness - Any	12 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Erythema (mm) - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Change in Eating Habits - Any	11 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Sleepiness - Severe	2 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Change in Eating Habits - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Body Temp. ( >= 38° C )	15 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Diarrhea - Any	9 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Analgesic / Antipyretic medication used	21 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	Tenderness - Severe	1 Subjects

Secondary

Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series

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

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	6 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	416 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	46 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	6 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	2 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	63 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	135 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	89 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	3 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	257 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	126 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	7 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	25 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	271 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	506 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	4 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	189 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	43 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	4 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	95 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	2 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	82 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	3 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	137 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	8 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	34 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	57 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	3 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	35 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	227 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	6 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	98 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	4 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	12 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	130 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	29 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	1 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	274 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	32 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	189 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	549 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	362 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	11 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	373 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	7 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	7 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	208 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	149 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	6 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	68 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	23 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	682 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	109 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	190 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	115 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	582 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	64 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	192 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	311 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	2 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	356 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	393 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	130 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	2 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	30 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	105 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	181 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	15 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	11 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	3 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	75 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	3 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	115 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	69 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	3 Subjects

Secondary

Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series

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.

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	37 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	15 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	58 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	6 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	28 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	19 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	75 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	4 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	2 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	1 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	0 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	16 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	37 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	13 Subjects
US1A (MenACWY- CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	9 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	73 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	15 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	6 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	41 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	45 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	18 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	4 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	9 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	9 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	22 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	26 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	82 Subjects
US2 (Infant Vaccine Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	1 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	41 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	30 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	11 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	2 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	131 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	22 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	13 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	5 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	12 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	34 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	82 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	0 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	78 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	54 Subjects
US1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	157 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	9 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	39 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	45 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	3 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	9 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	4 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	1 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	14 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	96 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	18 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	24 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	70 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	28 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	29 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	0 Subjects
US2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	2 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	94 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	349 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	189 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	1 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	2 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	31 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	59 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	179 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	3 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	4 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	6 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	4 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	92 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	33 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	41 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	0 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	135 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	14 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	285 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
US3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	2 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	67 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	53 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	92 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	7 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	20 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	39 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	2 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	26 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	157 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	6 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	74 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	4 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	8 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	91 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	20 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	1 Subjects
US4 (Infant Vaccines Only )	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	178 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	54 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	92 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	93 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	8 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	5 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	6 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	2 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	17 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	38 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	25 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	69 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	28 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	57 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	13 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	16 Subjects
LA1 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	2 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	10 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	29 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	25 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	38 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	8 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	27 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	2 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	11 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	9 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	0 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	2 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	15 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	15 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	1 Subjects
LA2 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	40 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	62 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	3 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	45 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	12 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	2 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	23 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	27 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	64 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	11 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	26 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	0 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	64 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	1 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	2 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	6 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	90 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	0 Subjects
LA3 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	78 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	1 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	28 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	9 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	12 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	14 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	1 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	50 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	1 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	17 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	32 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	51 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	12 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	0 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	11 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	38 Subjects
LA4 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	0 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	125 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	62 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	21 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	6 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	11 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	1 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	2 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	164 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	311 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	104 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	5 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	181 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	592 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	5 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	126 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	1 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	485 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	97 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	317 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	29 Subjects
LA5 (MenACWY-CRM + Infant Vaccines)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	504 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Body Temp. ( >= 38° C )	101 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Any	306 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Any	29 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Severe	2 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Any	273 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Irritability - Any	164 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Any	164 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Sleepiness - Severe	3 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Tenderness - Severe	14 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Severe	2 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Severe	0 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Erythema (mm) - Severe	1 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Rash - Severe	10 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Any	66 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Analgesic / Antipyretic medication used	342 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Change in Eating Habits - Severe	3 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Persistent Crying - Any	118 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Induration (mm) - Any	73 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Severe	1 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Vomiting - Any	52 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Severe	3 Subjects
LA6 (Infant Vaccines Only)	Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	Diarrhea - Any	58 Subjects

Secondary

Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects

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.

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects	Y Post-vaccination (84, 68)	41 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects	A Pre-vaccination (84, 74)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects	W Pre-vaccination (85, 73)	3 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects	A Post-vaccination (84, 74)	55 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects	Y Pre-vaccination (84, 68)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects	C Pre-vaccination (86, 73)	0 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects	W Post-vaccination (85, 73)	38 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects	C Post-vaccination (86, 73)	78 Percentages of subjects

Secondary

Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects

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.

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	W Pre-vaccination (98,112)	71 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	A Pre-vaccination (103, 120)	18 Percentages of subjects
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	C Pre-vaccination (102,122)	30 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	Y Pre-vaccination (98,109)	61 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	A Post-vaccination (103,120)	95 Percentages of subjects
US2 (Infant Vaccine Only)	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

Secondary

Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects

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.

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects	Y Post-vaccination (84, 68)	62 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects	A Pre-vaccination (84, 74)	3 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects	W Pre-vaccination (85, 73)	4 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects	A Post-vaccination (84, 74)	78 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects	Y Pre-vaccination (84, 68)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects	C Pre-vaccination (86, 73)	8 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects	W Post-vaccination (85, 73)	73 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects	C Post-vaccination (86, 73)	95 Percentages of subjects

Secondary

Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects

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.

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	A Pre-vaccination (103, 120)	13 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	W Pre-vaccination (98,112)	62 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	A Post-vaccination (103,120)	95 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	Y Pre-vaccination (98,109)	47 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	C Pre-vaccination (102,122)	22 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	W Post-vaccination (98,112)	100 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	C Post-vaccination (102,122)	98 Percentages of subjects

Secondary

Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects

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.

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects	Y Post-vaccination (84, 68)	56 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects	A Pre-vaccination (84, 74)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects	W Pre-vaccination (85, 73)	4 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects	A Post-vaccination (84, 74)	72 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects	Y Pre-vaccination (84, 68)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects	C Pre-vaccination (86, 73)	7 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects	W Post-vaccination (85, 73)	58 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects	C Post-vaccination (86, 73)	90 Percentages of subjects

Secondary

Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects

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.

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	C Post-vaccination (102, 122)	96 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	A Pre-vaccination (103, 120)	9 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	A Post-vaccination (103, 120)	94 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	C Pre-vaccination (102, 122)	18 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	Y Post-vaccination (98, 109)	98 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	W Pre-vaccination (98,112)	50 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	W Post-vaccination (98, 112)	100 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	Y Pre-vaccination (98,109)	32 Percentages of subjects

Secondary

Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects

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.

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	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)	5 Percentages of subjects
US2 (Infant Vaccine Only)	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)	97 Percentages of subjects
US2 (Infant Vaccine Only)	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)	0 Percentages of subjects
US2 (Infant Vaccine Only)	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)	1 Percentages of subjects
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects

Secondary

Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects

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) .

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

Population: Per protocol population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	A (Pre-vaccination hSBA titer ≥1:4; N= 272, 271)	2 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	A (Post-vaccination hSBA titer ≥1:4; N= 277, 268)	78 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	C (Pre-vaccination hSBA titer ≥1:4; N= 273,272)	10 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	C (Post-vaccination hSBA titer ≥1:4; N= 277, 272)	96 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	W (Pre-vaccination hSBA titer ≥1:4; N= 263, 261)	17 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	W (Post-vaccination hSBA titer ≥1:4; N=271,264)	100 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	Y (Pre-vaccination hSBA titer ≥1:4; N=258, 260)	11 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	Y (Post-vaccination hSBA titer ≥1:4; N=272,263)	98 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	Y (Post-vaccination hSBA titer ≥1:4; N=272,263)	99 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	A (Pre-vaccination hSBA titer ≥1:4; N= 272, 271)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	W (Pre-vaccination hSBA titer ≥1:4; N= 263, 261)	13 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	A (Post-vaccination hSBA titer ≥1:4; N= 277, 268)	91 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	Y (Pre-vaccination hSBA titer ≥1:4; N=258, 260)	8 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	C (Pre-vaccination hSBA titer ≥1:4; N= 273,272)	10 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	W (Post-vaccination hSBA titer ≥1:4; N=271,264)	99 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	C (Post-vaccination hSBA titer ≥1:4; N= 277, 272)	98 Percentages of subjects

Secondary

Percentage of Subjects With hSBA Titer >=1:4 - US Subjects

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.

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

Population: Per Protocol Population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	A (Pre-vaccination GMT; N= 177, 65)	2 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	A (Post-vaccination GMT; N= 212, 80)	71 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	C (Pre-vaccination GMT; N= 168, 64)	10 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	C (Post-vaccination GMT; N= 204, 84)	99 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	W (Pre-vaccination GMT; N= 165, 66)	22 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	W (Post-vaccination GMT; N=197, 90)	99 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	Y (Pre-vaccination GMT; N=150, 62 )	17 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	Y (Post-vaccination GMT; N=182, 84)	98 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	Y (Post-vaccination GMT; N=182, 84)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	A (Pre-vaccination GMT; N= 177, 65)	3 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	W (Pre-vaccination GMT; N= 165, 66)	15 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	A (Post-vaccination GMT; N= 212, 80)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	Y (Pre-vaccination GMT; N=150, 62 )	5 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	C (Pre-vaccination GMT; N= 168, 64)	5 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	W (Post-vaccination GMT; N=197, 90)	2 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	C (Post-vaccination GMT; N= 204, 84)	2 Percentages of subjects

Secondary

Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects

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) .

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

Population: Per protocol population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	A (Pre-vaccination hSBA titer ≥1:8; N= 272, 271)	1 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	A (Post-vaccination hSBA titer ≥1:8; N= 277, 268)	74 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	C (Pre-vaccination hSBA titer ≥1:8; N= 273,272)	4 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	C (Post-vaccination hSBA titer ≥1:8; N= 277, 272)	94 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	W (Pre-vaccination hSBA titer ≥1:8; N= 263, 261)	16 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	W (Post-vaccination hSBA titer ≥1:8; N=271,264)	99 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	Y (Pre-vaccination hSBA titer ≥1:8; N=258, 260)	5 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	Y (Post-vaccination hSBA titer ≥1:8; N=272,263)	97 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	Y (Post-vaccination hSBA titer ≥1:8; N=272,263)	98 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	A (Pre-vaccination hSBA titer ≥1:8; N= 272, 271)	0 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	W (Pre-vaccination hSBA titer ≥1:8; N= 263, 261)	10 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	A (Post-vaccination hSBA titer ≥1:8; N= 277, 268)	89 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	Y (Pre-vaccination hSBA titer ≥1:8; N=258, 260)	3 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	C (Pre-vaccination hSBA titer ≥1:8; N= 273,272)	4 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	W (Post-vaccination hSBA titer ≥1:8; N=271,264)	98 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	C (Post-vaccination hSBA titer ≥1:8; N= 277, 272)	97 Percentages of subjects

Comparison: Serogroup A (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))95% CI: [-21.2, -8.5]ANOVA

Comparison: Serogroup C (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))95% CI: [-7, 0.3]ANOVA

Comparison: Serogroup W (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))95% CI: [-1.3, 3.1]ANOVA

Comparison: Serogroup Y (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))95% CI: [-4, 1.7]ANOVA

Secondary

Percentage of Subjects With hSBA Titer >=1:8 - US Subjects

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.

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

Population: Per Protocol Population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	A (Pre-vaccination GMT; N= 177, 65)	2 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	A (Post-vaccination GMT; N= 212, 80)	67 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	C (Pre-vaccination GMT; N= 168, 64)	7 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	C (Post-vaccination GMT; N= 204, 84)	97 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	W (Pre-vaccination GMT; N= 165, 66)	17 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	W (Post-vaccination GMT; N=197, 90)	96 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	Y (Pre-vaccination GMT; N=150, 62 )	5 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	Y (Post-vaccination GMT; N=182, 84)	96 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	Y (Post-vaccination GMT; N=182, 84)	0 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	A (Pre-vaccination GMT; N= 177, 65)	3 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	W (Pre-vaccination GMT; N= 165, 66)	11 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	A (Post-vaccination GMT; N= 212, 80)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	Y (Pre-vaccination GMT; N=150, 62 )	3 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	C (Pre-vaccination GMT; N= 168, 64)	5 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	W (Post-vaccination GMT; N=197, 90)	2 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	C (Post-vaccination GMT; N= 204, 84)	1 Percentages of subjects

Secondary

Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject

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.

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

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject	A (84, 74)	12 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject	C (86, 73)	53 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject	W (85, 73)	80 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject	Y (84, 68)	74 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject	Y (84, 68)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject	A (84, 74)	3 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject	W (85, 73)	4 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject	C (86, 73)	8 Percentages of subjects

Secondary

Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject

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.

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	A (205, 78, 229, 101)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	Y (195, 71, 212, 95)	3 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	C (206, 78, 229, 102)	4 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	W (198, 70, 218, 98)	4 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	A (205, 78, 229, 101)	18 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	Y (195, 71, 212, 95)	65 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	W (198, 70, 218, 98)	72 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	C (206, 78, 229, 102)	32 Percentages of subjects
US2 (Infant Vaccines Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	Y (195, 71, 212, 95)	2 Percentages of subjects
US2 (Infant Vaccines Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	C (206, 78, 229, 102)	2 Percentages of subjects
US2 (Infant Vaccines Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	W (198, 70, 218, 98)	5 Percentages of subjects
US2 (Infant Vaccines Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	A (205, 78, 229, 101)	1 Percentages of subjects

Secondary

Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject

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.

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

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject	A (84, 74)	10 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject	C (86, 73)	50 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject	W (85, 73)	71 Percentages of subjects
US1A (MenACWY- CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject	Y (84, 68)	61 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject	Y (84, 68)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject	A (84, 74)	1 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject	W (85, 73)	4 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject	C (86, 73)	7 Percentages of subjects

Secondary

Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject

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.

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	C (206, 78, 229, 102)	4 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	W (198, 70, 218, 98)	4 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	Y (195, 71, 212, 95)	3 Percentages of subjects
US2 (Infant Vaccine Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	A (205, 78, 229, 101)	0 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	W (198, 70, 218, 98)	63 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	C (206, 78, 229, 102)	26 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	Y (195, 71, 212, 95)	52 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	A (205, 78, 229, 101)	15 Percentages of subjects
US2 (Infant Vaccines Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	Y (195, 71, 212, 95)	0 Percentages of subjects
US2 (Infant Vaccines Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	C (206, 78, 229, 102)	1 Percentages of subjects
US2 (Infant Vaccines Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	A (205, 78, 229, 101)	0 Percentages of subjects
US2 (Infant Vaccines Only)	Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	W (198, 70, 218, 98)	5 Percentages of subjects

Secondary

Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects

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

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

Population: Per Protocol

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	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)	95 Percentages of subjects
US2 (Infant Vaccine Only)	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)	89 Percentages of subjects
US2 (Infant Vaccine Only)	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)	95 Percentages of subjects
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects
US2 (Infant Vaccine Only)	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)	95 Percentages of subjects
US2 (Infant Vaccine Only)	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)	93 Percentages of subjects

Comparison: PnC 4 (percentage difference (LA1A - LA1B))95% CI: [-9.6, 5.2]ANOVA

Comparison: PnC 6B (percentage difference (LA1A - LA1B))95% CI: [-11.9, 7.3]ANOVA

Comparison: PnC 9V (percentage difference (LA1A - LA1B))95% CI: [-10.9, 4.3]ANOVA

Comparison: PnC 14 (percentage difference (LA1A - LA1B))95% CI: [-5.6, 2.7]ANOVA

Comparison: PnC 18C (percentage difference (LA1A - LA1B))95% CI: [-24.1, -5.6]ANOVA

Comparison: PnC 19F (percentage difference (LA1A - LA1B))95% CI: [-11.6, 5.2]ANOVA

Comparison: PnC 23F (percentage difference (LA1A - LA1B))95% CI: [-7, 7]ANOVA

Secondary

Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects

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.

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

Population: Per Protocol

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects
US2 (Infant Vaccine Only)	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)	90 Percentages of subjects
US2 (Infant Vaccine Only)	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)	96 Percentages of subjects
US2 (Infant Vaccine Only)	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)	91 Percentages of subjects
US2 (Infant Vaccine Only)	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)	92 Percentages of subjects
US2 (Infant Vaccine Only)	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)	93 Percentages of subjects
US2 (Infant Vaccine Only)	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)	95 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	94 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	99 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	99 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	99 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	100 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	86 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	84 Percentages of subjects

Comparison: PnC 4 (percentage difference (US1A - US1B))95% CI: [-8, 10]ANOVA

Comparison: PnC 6B (percentage difference (US1A - US1B))95% CI: [0, 10]ANOVA

Comparison: PnC 9V (percentage difference (US1A - US1B))95% CI: [-13, 5]ANOVA

Comparison: PnC 14 (percentage difference (US1A - US1B))95% CI: [-6, 3]ANOVA

Comparison: PnC 18C (percentage difference (US1A:US1B))95% CI: [-15, 3]ANOVA

Comparison: PnC 19F (percentage difference (US1A:US1B))95% CI: [-4, 11]ANOVA

Comparison: PnC 239F (percentage difference (US1A:US1B))95% CI: [-10, 5]ANOVA

Secondary

Persistence Antibodies Geometric Mean Titers - LA Subjects

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

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	Persistence Antibodies Geometric Mean Titers - LA Subjects	A (205, 78, 229, 101)	4.26 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Persistence Antibodies Geometric Mean Titers - LA Subjects	C (206, 78, 229, 102)	12 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Persistence Antibodies Geometric Mean Titers - LA Subjects	W (198, 70, 218, 98)	31 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Persistence Antibodies Geometric Mean Titers - LA Subjects	Y (195, 71, 212, 95)	18 Titers
US2 (Infant Vaccine Only)	Persistence Antibodies Geometric Mean Titers - LA Subjects	C (206, 78, 229, 102)	2.18 Titers
US2 (Infant Vaccine Only)	Persistence Antibodies Geometric Mean Titers - LA Subjects	W (198, 70, 218, 98)	2.34 Titers
US2 (Infant Vaccine Only)	Persistence Antibodies Geometric Mean Titers - LA Subjects	Y (195, 71, 212, 95)	2.2 Titers
US2 (Infant Vaccine Only)	Persistence Antibodies Geometric Mean Titers - LA Subjects	A (205, 78, 229, 101)	2.02 Titers
US1 (MenACWY-CRM + Infant Vaccines)	Persistence Antibodies Geometric Mean Titers - LA Subjects	W (198, 70, 218, 98)	14 Titers
US1 (MenACWY-CRM + Infant Vaccines)	Persistence Antibodies Geometric Mean Titers - LA Subjects	C (206, 78, 229, 102)	4.14 Titers
US1 (MenACWY-CRM + Infant Vaccines)	Persistence Antibodies Geometric Mean Titers - LA Subjects	Y (195, 71, 212, 95)	9.45 Titers
US1 (MenACWY-CRM + Infant Vaccines)	Persistence Antibodies Geometric Mean Titers - LA Subjects	A (205, 78, 229, 101)	2.96 Titers
US2 (Infant Vaccines Only)	Persistence Antibodies Geometric Mean Titers - LA Subjects	Y (195, 71, 212, 95)	2.04 Titers
US2 (Infant Vaccines Only)	Persistence Antibodies Geometric Mean Titers - LA Subjects	C (206, 78, 229, 102)	2.05 Titers
US2 (Infant Vaccines Only)	Persistence Antibodies Geometric Mean Titers - LA Subjects	A (205, 78, 229, 101)	2.02 Titers
US2 (Infant Vaccines Only)	Persistence Antibodies Geometric Mean Titers - LA Subjects	W (198, 70, 218, 98)	2.33 Titers

Secondary

Persistence Antibodies Geometric Mean Titers - US Subject

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

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

Population: The analysis was done on per protocol population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
US1A (MenACWY- CRM + Infant Vaccines)	Persistence Antibodies Geometric Mean Titers - US Subject	A (84, 74)	2.51 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Persistence Antibodies Geometric Mean Titers - US Subject	W (85, 73)	14 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Persistence Antibodies Geometric Mean Titers - US Subject	C (86, 73)	7.72 Titers
US1A (MenACWY- CRM + Infant Vaccines)	Persistence Antibodies Geometric Mean Titers - US Subject	Y (84, 68)	11 Titers
US2 (Infant Vaccine Only)	Persistence Antibodies Geometric Mean Titers - US Subject	C (86, 73)	2.26 Titers
US2 (Infant Vaccine Only)	Persistence Antibodies Geometric Mean Titers - US Subject	A (84, 74)	2.14 Titers
US2 (Infant Vaccine Only)	Persistence Antibodies Geometric Mean Titers - US Subject	Y (84, 68)	2.14 Titers
US2 (Infant Vaccine Only)	Persistence Antibodies Geometric Mean Titers - US Subject	W (85, 73)	2.21 Titers

Secondary

Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects

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

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

Population: Per Protocol

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	Hib (≥1.0 μg/mL) (N=117, N=101)	99 Percentages of subjects
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	PT (≥4 fold rise) (N=113, N=99)	84 Percentages of subjects
US2 (Infant Vaccine Only)	Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	FHA (≥4-fold rise) (N=113, N=99)	88 Percentages of subjects
US2 (Infant Vaccine Only)	Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	Pertactin (≥4-fold rise) (N=113, N=99)	88 Percentages of subjects
US2 (Infant Vaccine Only)	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

Comparison: Diphtheria (percentage difference (LA3A - LA3B))95% CI: [-4.2, 5.4]ANOVA

Comparison: Tetanus (percentage difference (LA3A - LA3B))95% CI: [-4.2, 5.4]ANOVA

Comparison: PT (percentage difference (LA3A - LA3B))95% CI: [-3.6, 15.2]ANOVA

Comparison: FHA (percentage difference (LA3A - LA3B))95% CI: [-10.2, 8.2]ANOVA

Comparison: Pertactin (percentage difference (LA3A - LA3B))95% CI: [-7.2, 10.6]ANOVA

Comparison: Hib (≥ 0.15 μg/mL) (percentage difference (LA3A - LA3B))95% CI: [-3.1, 3.6]ANOVA

Comparison: Hib (≥1.0 μg/mL) (percentage difference (LA3A - LA3B))95% CI: [-2.2, 5.3]ANOVA

Secondary

Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects

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

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

Population: Per Protocol

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	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)	86 Percentages of subjects
US2 (Infant Vaccine Only)	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)	98 Percentages of subjects
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	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)	86 Percentages of subjects
US2 (Infant Vaccine Only)	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)	87 Percentages of subjects
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects
US2 (Infant Vaccine Only)	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)	99 Percentages of subjects
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	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)	98 Percentages of subjects
US2 (Infant Vaccine Only)	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)	93 Percentages of subjects
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	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)	86 Percentages of subjects
US2 (Infant Vaccine Only)	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)	98 Percentages of subjects
US2 (Infant Vaccine Only)	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)	97 Percentages of subjects
US2 (Infant Vaccine Only)	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)	98 Percentages of subjects
US2 (Infant Vaccine Only)	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)	98 Percentages of subjects
US2 (Infant Vaccine Only)	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)	97 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	86 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	97 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	93 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	82 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	95 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	97 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	98 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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
US1 (MenACWY-CRM + Infant Vaccines)	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
US1 (MenACWY-CRM + Infant Vaccines)	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
US1 (MenACWY-CRM + Infant Vaccines)	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
US1 (MenACWY-CRM + Infant Vaccines)	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)	98 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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
US1 (MenACWY-CRM + Infant Vaccines)	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)	98 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	99 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	96 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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)	95 Percentages of subjects
US1 (MenACWY-CRM + Infant Vaccines)	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
US2 (Infant Vaccines Only)	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)	98 Percentages of subjects
US2 (Infant Vaccines Only)	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)	98 Percentages of subjects
US2 (Infant Vaccines Only)	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)	96 Percentages of subjects
US2 (Infant Vaccines Only)	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
US2 (Infant Vaccines Only)	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)	81 Percentages of subjects
US2 (Infant Vaccines Only)	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
US2 (Infant Vaccines Only)	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
US2 (Infant Vaccines Only)	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)	96 Percentages of subjects
US2 (Infant Vaccines Only)	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)	88 Percentages of subjects
US2 (Infant Vaccines Only)	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)	94 Percentages of subjects
US2 (Infant Vaccines Only)	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)	98 Percentages of subjects
US2 (Infant Vaccines Only)	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)	98 Percentages of subjects
US2 (Infant Vaccines Only)	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)	82 Percentages of subjects
US2 (Infant Vaccines Only)	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
US2 (Infant Vaccines Only)	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
US2 (Infant Vaccines Only)	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)	90 Percentages of subjects
US2 (Infant Vaccines Only)	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
US2 (Infant Vaccines Only)	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)	96 Percentages of subjects

Comparison: Diphtheria (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-2.2, 4.4]ANOVA

Comparison: Tetanus (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-1.9, 2.6]ANOVA

Comparison: PT (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-7.7, 7.1]ANOVA

Comparison: FHA(Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-9.2, 5.8]ANOVA

Comparison: Pertactin (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-12.9, 2.2]ANOVA

Comparison: Polio Type 1 (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-4.8, 1]ANOVA

Comparison: Polio Type 2 (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-4.6, 2.3]ANOVA

Comparison: Polio Type 3 (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-3.2, 5.1]ANOVA

Comparison: Hepatitis B (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-1.5, 3.5]ANOVA

Comparison: Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-1.1, 5]ANOVA

Comparison: Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-2.8, 7.7]ANOVA

Comparison: PnC 4(Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-3, 3.3]ANOVA

Comparison: PnC 6B(Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-2.2, 12.3]ANOVA

Comparison: PnC 9V (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-3.9, 3.6]ANOVA

Comparison: PnC 14 (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-1.1, 6.2]ANOVA

Comparison: PnC 18C (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-4.8, 2.9]ANOVA

Comparison: PnC 19F (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-4.8, 2.9]ANOVA

Comparison: PnC 23F (Seroconversion percentage difference (PLA1 - PLA2))95% CI: [-8, 1.9]ANOVA

Comparison: Diphtheria (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-2.3, 3.8]ANOVA

Comparison: Tetanus (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-1.3, 2.7]ANOVA

Comparison: PT (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-4.8, 10.7]Seroconversion Percentage difference

Comparison: FHA(Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-7.1, 8.8]ANOVA

Comparison: Pertactin (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-8, 5.7]ANOVA

Comparison: Polio Type 1 (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-2, 4.7]ANOVA

Comparison: Polio Type 2 (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-3, 4.8]ANOVA

Comparison: Polio Type 3 (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-4.4, 4.5]ANOVA

Comparison: Hepatitis B (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-2.3, 2.7]ANOVA

Comparison: Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-5.3, 1]ANOVA

Comparison: Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-6.6, 3]ANOVA

Comparison: PnC 4 (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-4.2, 3]ANOVA

Comparison: PnC 6B (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-4, 9]ANOVA

Comparison: PnC 9V (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-2.8, 6]ANOVA

Comparison: PnC 14 (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-3.7, 3.4]ANOVA

Comparison: PnC 18C (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-7.2, 0.8]ANOVA

Comparison: PnC 19F (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-0.8, 7.5]ANOVA

Comparison: PnC 23F (Seroconversion percentage difference (PLA3 - PLA4))95% CI: [-3.7, 7]ANOVA

Secondary

Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects

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

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

Population: Per Protocol

Arm	Measure	Group	Value (NUMBER)
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US1A (MenACWY- CRM + Infant Vaccines)	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
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	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)	94 Percentages of subjects
US2 (Infant Vaccine Only)	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)	86 Percentages of subjects
US2 (Infant Vaccine Only)	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)	84 Percentages of subjects
US2 (Infant Vaccine Only)	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)	80 Percentages of subjects
US2 (Infant Vaccine Only)	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)	99 Percentages of subjects
US2 (Infant Vaccine Only)	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)	78 Percentages of subjects
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects
US2 (Infant Vaccine Only)	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
US2 (Infant Vaccine Only)	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)	96 Percentages of subjects
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects
US2 (Infant Vaccine Only)	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)	100 Percentages of subjects

Comparison: Diphtheria (Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-3, 3]ANOVA

Comparison: Tetanus (Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-2, 4]ANOVA

Comparison: PT (Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-7, 12]ANOVA

Comparison: FHA(Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-4, 17]ANOVA

Comparison: Pertactin (Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-12, 10]ANOVA

Comparison: Polio Type 1 (Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-3, 3]ANOVA

Comparison: Polio Type 2 (Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-2, 4]ANOVA

Comparison: Polio Type 3 (Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-3, 3]ANOVA

Comparison: Hepatitis B(Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-4, 3]ANOVA

Comparison: Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-3, 3]ANOVA

Comparison: Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-3, 14]ANOVA

Comparison: PnC 4(Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-5, 2]ANOVA

Comparison: PnC 6B(Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-14, -1]ANOVA

Comparison: PnC 9V (Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-4, 5]ANOVA

Comparison: PnC 14 (Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-1, 5]ANOVA

Comparison: PnC 18C (Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-6, 1]ANOVA

Comparison: PnC 19F (Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-4, 3]ANOVA

Comparison: PnC 23F (Seroconversion percentage difference (PUS1 - PUS2))95% CI: [-8, 5]ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Geometric Mean hSBA Titers - US Subjects

Percentage of Subjects With hSBA Titer >=1:8 - US Subjects

Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects

Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects

Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects

Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects

Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects

Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects

Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects

Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects

Geometric Mean hSBA Titers Post-infant Series - LA Subjects

Geometric Mean hSBA Titers Post-infant Series - US Subjects

Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age

Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series

Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series

Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series

Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series

Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series

Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series

Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series

Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series

Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects

Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects

Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects

Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects

Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects

Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects

Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects

Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects

Percentage of Subjects With hSBA Titer >=1:4 - US Subjects

Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects

Percentage of Subjects With hSBA Titer >=1:8 - US Subjects

Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject

Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject

Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject

Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject

Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects

Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects

Persistence Antibodies Geometric Mean Titers - LA Subjects

Persistence Antibodies Geometric Mean Titers - US Subject

Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects

Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects

Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects