A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months

A Phase 3, Randomized, Open Label, Controlled Multicenter Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01000311

Enrollment

529

Registered

2009-10-23

Start date

2009-11-30

Completion date

2011-11-30

Last updated

2014-04-21

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

Conditions

Meningococcal Disease

Keywords

MenACWY conjugate vaccine in infants, Meningococcal vaccine in infants, MenACWY

Brief summary

This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.

Interventions

BIOLOGICALMenACWY-CRM

One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2, 4, 6 and 12 months of age as IM injections in the anterolateral area of the thigh.

BIOLOGICALDTaP-IPV/Hib

IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.

BIOLOGICALHBV

IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.

BIOLOGICALPCV

IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh.

BIOLOGICALMMR

Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Days to 89 Days

Healthy volunteers

Yes

Inclusion criteria

1. Two month-old infants, born after a full-term pregnancy with an estimated gestational age ≥37 weeks and a birth weight ≥2.5 kg. 2. Documented written informed consent provided by the parent/legal representative after the nature of the study had been explained. 3. Parent/legal representative was available for all visits scheduled in the study. 4. Subjects were in good health as determined by: 1. medical history 2. physical assessment 3. clinical judgment of the investigator

Exclusion criteria

1. Subjects who previously received any meningococcal vaccines or vaccines against diphtheria, tetanus, pertussis, polio (IPV or OPV), H. influenzae type b (Hib) or pneumococcus. Exceptions: prior doses HBV vaccination (one or two doses) are permitted. 2. Subjects who had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, poliovirus, Hepatitis B, Hib, pneumococcus or B. pertussis (history of laboratory confirmed, or clinical condition of paroxysmal cough for a period of longer than or equal to 2 weeks associated with apnea or whooping). 3. Subjects who had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis, B. pertussis, Hib, C. diphtheriae, polio, or pneumococcal infection at any time since birth. 4. Subjects who had a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component. 5. Subjects who had experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C \[100.4°F\]) within the previous 3 days. 6. Subjects who had any serious acute or chronic disease, neurological disease including seizures, congenital defects, or cytogenic disorders (e.g., Down syndrome). 7. Subjects who had a known or suspected autoimmune disease or persistent impairment/alteration of immune function. 8. Subjects who had a suspected or known HIV infection or were born to a mother known to be HIV positive. 9. Subjects who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin). 10. Subjects who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 11. Subjects who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period. 12. Subjects who had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. 13. Subjects who received any investigational agents or vaccines since birth or who expect to receive an investigational agent or vaccine prior to the completion of the study. 14. Subjects who were relatives of site research staff working on this study.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Baseline and one month after fourth-dose of MenACWY-CRM	Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age. The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A.

Secondary

Measure	Time frame	Description
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Baseline and one month after third infant dose of MenACWY-CRM	Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, before (baseline) and one month after 3 infant doses of MenACWY-CRM administered at 2, 4 and 6 months of age. Percentage of subjects who achieved at least four-fold rise in hSBA titers against serogroup A, C, W and Y was measured one month after 3 infant doses of MenACWY-CRM.
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Baseline and one month after third infant dose of MenACWY-CRM	Immunogenicity was measured as the hSBA GMTs directed against meningococcal serogroups A, C, W and Y before (baseline) and one month after 3 infants doses of MenACWY-CRM administered at 2, 4 and 6 months of age.
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	One month after third dose of routine infant series vaccination	The immune seroresponse to routine concomitant vaccination was measured as the percentages of subjects with pre-specified cut-off limit of ≥0.1 IU/mL (Diphtheria and Tetanus); ≥0.15 μg/mL (Hib); ≥0.35 μg/mL (Pneumococcal antigens, PnC); and ≥10 mIU/mL (Hepatitis B), evaluated using enzyme-linked immunosorbent assay (ELISA) at one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age. The immune response to pertussis antigens (PT, FHA, Pertactin, FIM) was measured as percentage of subjects with seroresponse (in initially seronegative infants, ≥4 times the lower limit of quantification (LLQ); in initially seropositive infants, at least 4 times prevaccination concentration) by ELISA and percentage of subjects with titer ≥1:8 (Polio types 1, 2, and 3) by neutralization test (NT) one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age.
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	One month after third dose of routine infant series vaccination	The immune response was measured as the geometric mean concentrations (GMCs) of antibodies directed against diphtheria, tetanus, pertussis (PT, FHA, Pertactin, FIM), hepatitis B, Hib, polio (type 1, 2 and 3) and pneumococcal (PnC 4, 6B, 9V, 14, 18C, 19F and 23F) antigens when routine vaccines are administered concomitantly with MenACWY-CRM compared with when routine vaccines are given alone, one month after 3 doses of infant series vaccination at 2, 4 and 6 months of age.
Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	One month after PCV toddler vaccination	Immunogenicity was measured as the GMCs of anti-pneumococcal antibodies against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age administered concomitantly with MenACWY-CRM compared with PCV given alone.
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Baseline and one month after fourth-dose of MenACWY-CRM	Immunogenicity was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal serogroup A, C, W and Y, at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.
Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Baseline and Six months after third infant dose of MenACWY-CRM	The antibody persistence was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.
Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Baseline and Six months after third infant dose of MenACWY-CRM	The antibody persistence was measured as the hSBA GMTs directed against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.
Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	One month after MenACWY-CRM toddler vaccination	The immune response was measured as the percentage of subjects who achieved four-fold increase in hSBA titers against meningococcal serogroup A, C, W and Y one month after toddler dose of MenACWY-CRM administered at 12 months of age as compared to hSBA titers before the toddler vaccination.
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	From day 1 to 18 months	Safety of the study vaccines (MenACWY-CRM and other routine vaccines) was assessed in terms of the number of subjects who reported adverse events (AEs) and/or serious AEs per vaccine group at the following time points: entire study period, after infants vaccination (up to 7 months), between 2- and 4-months, between 4- and 6-months, between 6- and 12-months, between 7- and 12-months, 28 days after 12-month vaccination, and between 29 days after 12-month vaccination and study termination. Solicited reactions were not collected during this study. The safety analyses also included any AEs observed by study personnel within 15 minutes following vaccination. All AEs and SAEs were judged by the investigator as whether probably related, possibly related, or not related to vaccine.
Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	One month after PCV toddler vaccination	The immune seroresponse was measured as the percentage of subjects with anti-pneumococcal antigen antibodies ≥0.35 μg/mL against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age when administered concomitantly with MenACWY-CRM compared with PCV given alone.

Countries

Australia, Canada, United States

Participant flow

Recruitment details

Subjects were enrolled at 42 study sites in the United States, 3 sites in Australia and 1 site in Canada.

Pre-assignment details

All enrolled subjects were included in the study.

Participants by arm

Arm	Count
MenACWY-CRM + Routine Vaccines Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months. Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.	258
Routine Vaccines Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.	271
Total	529

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Administrative reason	9	15
Overall Study	Adverse Event	2	5
Overall Study	Inappropriate enrollment	2	0
Overall Study	Lost to Follow-up	15	24
Overall Study	Protocol Violation	1	2
Overall Study	Withdrawal by Subject	16	24

Baseline characteristics

Characteristic	MenACWY-CRM + Routine Vaccines	Routine Vaccines	Total
Age, Continuous	64.7 Days STANDARD_DEVIATION 6.5	65.4 Days STANDARD_DEVIATION 7.4	65.1 Days STANDARD_DEVIATION 7
Sex: Female, Male Female	125 Participants	130 Participants	255 Participants
Sex: Female, Male Male	133 Participants	141 Participants	274 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	216 / 255	227 / 270
serious Total, serious adverse events	21 / 255	20 / 270

Outcome results

Primary

Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM

Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age. The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A.

Time frame: Baseline and one month after fourth-dose of MenACWY-CRM

Population: Analysis was done on the per-protocol (PP) toddler dataset for MenACWY-CRM, i.e. the subjects who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to database lock.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup A - Baseline (N=170,178)	2 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup A - Post-4th dose (N=168,175)	89 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup C - Baseline (N=166,174)	7 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup C - Post-4th dose (N=156,171)	95 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup W - Baseline (N=152,164)	13 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup W - Post-4th dose (N=153,165)	97 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup Y - Baseline (N=144,150)	8 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup Y - Post-4th dose (N=153,159)	96 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup Y - Post-4th dose (N=153,159)	1 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup A - Baseline (N=170,178)	1 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup W - Baseline (N=152,164)	15 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup A - Post-4th dose (N=168,175)	2 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup Y - Baseline (N=144,150)	4 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup C - Baseline (N=166,174)	7 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup W - Post-4th dose (N=153,165)	7 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup C - Post-4th dose (N=156,171)	2 Percentage of subjects

Comparison: The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 80% for the serogroup A.95% CI: [83, 93]

Comparison: The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup C.95% CI: [90, 98]

Secondary

Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination

The antibody persistence was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.

Time frame: Baseline and Six months after third infant dose of MenACWY-CRM

Population: Analysis was performed on the PP toddler dataset for MenACWY-CRM.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM + Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup A - Baseline (N=139, 145)	1 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup A - 6 mo Post-3rd dose (N=168,175)	7 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup C - Baseline (N=126,136)	7 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup C - 6 mo Post-3rd dose (N=156,171)	37 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup W - Baseline (N=152,164)	15 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup W - 6 mo Post-3rd dose (N=153,165)	70 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup Y - Baseline (N=108,113)	6 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup Y - 6 mo Post-3rd dose (N=153,159)	53 Percentage of subjects
Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup Y - 6 mo Post-3rd dose (N=153,159)	3 Percentage of subjects
Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup A - Baseline (N=139, 145)	0 Percentage of subjects
Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup W - Baseline (N=152,164)	15 Percentage of subjects
Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup A - 6 mo Post-3rd dose (N=168,175)	2 Percentage of subjects
Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup Y - Baseline (N=108,113)	5 Percentage of subjects
Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup C - Baseline (N=126,136)	8 Percentage of subjects
Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup W - 6 mo Post-3rd dose (N=153,165)	5 Percentage of subjects
Routine Vaccines	Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup C - 6 mo Post-3rd dose (N=156,171)	2 Percentage of subjects

Secondary

Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone

Immunogenicity was measured as the GMCs of anti-pneumococcal antibodies against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age administered concomitantly with MenACWY-CRM compared with PCV given alone.

Time frame: One month after PCV toddler vaccination

Population: Analysis was performed on the PP pneumococcal toddler population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 9V (N=161,170)	1.67 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 18C (N=161,170)	1.79 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 6B (N=161,170)	5.92 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 19F (N=161,170)	5.03 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 14 (N=161,170)	7.9 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 23F (N=161,170)	3.3 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 4 (N=161,170)	1.57 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 23F (N=161,170)	3.91 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 4 (N=161,170)	1.6 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 6B (N=161,170)	7.8 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 9V (N=161,170)	1.91 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 14 (N=161,170)	7.61 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 18C (N=161,170)	1.8 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 19F (N=161,170)	5.68 μg/mL

Comparison: To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 4 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone95% CI: [0.8, 1.19]ANOVA

Comparison: To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 6B antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone95% CI: [0.62, 0.93]ANOVA

Comparison: To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 9V antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone95% CI: [0.72, 1.06]ANOVA

Comparison: To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 14 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone95% CI: [0.84, 1.28]ANOVA

Comparison: To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 18C antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone95% CI: [0.82, 1.2]ANOVA

Comparison: To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 19F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone95% CI: [0.73, 1.07]ANOVA

Comparison: To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 23F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone95% CI: [0.68, 1.04]ANOVA

Secondary

Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone

The immune response was measured as the geometric mean concentrations (GMCs) of antibodies directed against diphtheria, tetanus, pertussis (PT, FHA, Pertactin, FIM), hepatitis B, Hib, polio (type 1, 2 and 3) and pneumococcal (PnC 4, 6B, 9V, 14, 18C, 19F and 23F) antigens when routine vaccines are administered concomitantly with MenACWY-CRM compared with when routine vaccines are given alone, one month after 3 doses of infant series vaccination at 2, 4 and 6 months of age.

Time frame: One month after third dose of routine infant series vaccination

Population: Analysis was performed on the PP datasets of infants for concomitant, pertussis and hepatitis B vaccinations

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Diphtheria (N=207,218)	0.7 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Tetanus (N=207,218)	0.8 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PT (N=185,191)	25 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	FHA (N=185,191)	48 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Pertactin (N=185,191)	56 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	FIM (N=185,191)	133 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Polio Type 1 (N=115,113)	149 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Polio Type 2 (N=185,179)	210 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Polio Type 3 (N=164,162)	457 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Hepatitis B (N=138,148)	394 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Hib (N=187,194)	3.75 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 4 (N=183,178)	1.3 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 6B (N=183,178)	1.42 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 9V (N=183,178)	0.95 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 14 (N=183,178)	6.31 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 18C (N=183,178)	1.36 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 19F (N=183,178)	1.84 μg/mL
MenACWY-CRM + Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 23F (N=183,178)	1.15 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 9V (N=183,178)	1.2 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Diphtheria (N=207,218)	0.85 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Hepatitis B (N=138,148)	402 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Tetanus (N=207,218)	0.67 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 23F (N=183,178)	1.33 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PT (N=185,191)	24 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Hib (N=187,194)	2.76 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	FHA (N=185,191)	47 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 14 (N=183,178)	6.61 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Pertactin (N=185,191)	54 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 4 (N=183,178)	1.45 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	FIM (N=185,191)	122 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 19F (N=183,178)	2.04 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Polio Type 1 (N=115,113)	117 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 6B (N=183,178)	1.79 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Polio Type 2 (N=185,179)	185 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 18C (N=183,178)	1.42 μg/mL
Routine Vaccines	Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Polio Type 3 (N=164,162)	402 μg/mL

Comparison: To demonstrate the non-inferiority of GMC of antibodies to pertussis toxin (PT), when DTaP is given with MenACWY-CRM compared with when DTap is given alone95% CI: [0.81, 1.28]ANOVA

Comparison: To demonstrate the non-inferiority of GMC of antibodies to pertussis FHA antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone95% CI: [0.9, 1.19]ANOVA

Comparison: To demonstrate the non-inferiority of GMC of antibodies to pertussis pertactin antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone95% CI: [0.84, 1.28]ANOVA

Comparison: To demonstrate the non-inferiority of GMC of antibodies to pertussis FIM antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone95% CI: [0.88, 1.35]ANOVA

Secondary

hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM

Immunogenicity was measured as the hSBA GMTs directed against meningococcal serogroups A, C, W and Y before (baseline) and one month after 3 infants doses of MenACWY-CRM administered at 2, 4 and 6 months of age.

Time frame: Baseline and one month after third infant dose of MenACWY-CRM

Population: Analysis was performed on the PP dataset of MenACWY-CRM infant vaccination series.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup Y - Baseline (N=144,150)	2.52 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup A - Baseline (N=170,178)	2.09 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup A - Post-3rd dose (N=202,208)	21 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup C - Baseline (N=166,174)	2.49 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup C - Post-3rd dose (N=199,206)	74 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup W - Baseline (N=152,164)	2.94 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup W - Post-3rd dose (N=194,202)	79 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup Y - Post-3rd dose (N=188,196)	51 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup Y - Post-3rd dose (N=188,196)	2.13 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup Y - Baseline (N=144,150)	2.26 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup C - Post-3rd dose (N=199,206)	1.94 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup A - Baseline (N=170,178)	2.05 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup W - Post-3rd dose (N=194,202)	1.94 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup A - Post-3rd dose (N=202,208)	2.08 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup W - Baseline (N=152,164)	2.98 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup C - Baseline (N=166,174)	2.39 Titers

Secondary

hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM

Immunogenicity was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal serogroup A, C, W and Y, at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.

Time frame: Baseline and one month after fourth-dose of MenACWY-CRM

Population: Analysis was performed on the PP toddler dataset for MenACWY-CRM vaccination.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup A - Baseline (N=139,145)	2.07 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup W - Baseline (N=113,126)	2.99 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup C - Baseline (N=126,136)	2.49 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup W - Post-4th dose (N=153,165)	215 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup Y - Baseline (N=108,113)	2.43 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup A - Post-4th dose (N=168,175)	54 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup Y - Post-4th dose (N=153,159)	185 Titers
MenACWY-CRM + Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup C - Post-4th dose (N=156,171)	135 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup Y - Post-4th dose (N=153,159)	1.89 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup A - Baseline (N=139,145)	2.01 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup A - Post-4th dose (N=168,175)	1.87 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup C - Baseline (N=126,136)	2.44 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup C - Post-4th dose (N=156,171)	1.94 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup W - Baseline (N=113,126)	2.97 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup Y - Baseline (N=108,113)	2.32 Titers
Routine Vaccines	hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup W - Post-4th dose (N=153,165)	2.15 Titers

Secondary

Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone

The immune seroresponse was measured as the percentage of subjects with anti-pneumococcal antigen antibodies ≥0.35 μg/mL against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age when administered concomitantly with MenACWY-CRM compared with PCV given alone.

Time frame: One month after PCV toddler vaccination

Population: Analysis was performed on the PP pneumococcal toddler population.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 9V (N=161,170)	97 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 18C (N=161,170)	96 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 6B (N=161,170)	99 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 19F (N=161,169)	99 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 14 (N=161,170)	99 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 23F (N=161,170)	99 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 4 (N=161,170)	93 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 23F (N=161,170)	98 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 4 (N=161,170)	96 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 6B (N=161,170)	98 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 9V (N=161,170)	96 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 14 (N=161,170)	99 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 18C (N=161,170)	98 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone	PnC 19F (N=161,169)	100 Percentage of subjects

Secondary

Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM

The immune response was measured as the percentage of subjects who achieved four-fold increase in hSBA titers against meningococcal serogroup A, C, W and Y one month after toddler dose of MenACWY-CRM administered at 12 months of age as compared to hSBA titers before the toddler vaccination.

Time frame: One month after MenACWY-CRM toddler vaccination

Population: Analysis was performed on the PP toddler dataset for MenACWY-CRM.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup A (N=168,175)	89 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup C (N=156,171)	92 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup W (N=153,165)	95 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup Y (N=153,159)	96 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup Y (N=153,159)	1 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup A (N=168,175)	1 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup W (N=153,165)	2 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM	Serogroup C (N=156,171)	1 Percentage of subjects

Secondary

Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM

Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, before (baseline) and one month after 3 infant doses of MenACWY-CRM administered at 2, 4 and 6 months of age. Percentage of subjects who achieved at least four-fold rise in hSBA titers against serogroup A, C, W and Y was measured one month after 3 infant doses of MenACWY-CRM.

Time frame: Baseline and one month after third infant dose of MenACWY-CRM

Population: Analysis was performed on the PP dataset of MenACWY-CRM infant vaccination series.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup A - hSBA ≥1:8-Baseline (N=170,178)	2 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup A - hSBA ≥1:8 -Post-3rd dose(N=202,208)	76 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup C - hSBA ≥1:8 -Baseline(N=166,174)	7 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup C - hSBA ≥1:8 -Post-3rd dose(N=199,206)	94 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup W - hSBA ≥1:8 -Baseline(N=152,164)	13 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup W - hSBA ≥1:8 -Post-3rd dose(N=194,202)	98 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup Y - hSBA ≥1:8 -Baseline(N=144,150)	8 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup Y - hSBA ≥1:8 -Post-3rd dose(N=188,196)	94 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup A - 4-fold rise-Post-3rd dose(N=170,177)	78 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup C - 4-fold rise-Post-3rd dose(N=164,171)	94 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup W - 4-fold rise-Post-3rd dose(N=147,158)	93 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup Y -4-fold rise-Post-3rd dose(N=135,142)	93 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup W - 4-fold rise-Post-3rd dose(N=147,158)	2 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup A - hSBA ≥1:8-Baseline (N=170,178)	1 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup Y - hSBA ≥1:8 -Baseline(N=144,150)	4 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup A - hSBA ≥1:8 -Post-3rd dose(N=202,208)	1 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup C - 4-fold rise-Post-3rd dose(N=164,171)	1 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup C - hSBA ≥1:8 -Baseline(N=166,174)	7 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup Y - hSBA ≥1:8 -Post-3rd dose(N=188,196)	3 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup C - hSBA ≥1:8 -Post-3rd dose(N=199,206)	1 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup Y -4-fold rise-Post-3rd dose(N=135,142)	2 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup W - hSBA ≥1:8 -Baseline(N=152,164)	15 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup A - 4-fold rise-Post-3rd dose(N=170,177)	2 Percentage of subjects
Routine Vaccines	Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM	Serogroup W - hSBA ≥1:8 -Post-3rd dose(N=194,202)	3 Percentage of subjects

Secondary

Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone

The immune seroresponse to routine concomitant vaccination was measured as the percentages of subjects with pre-specified cut-off limit of ≥0.1 IU/mL (Diphtheria and Tetanus); ≥0.15 μg/mL (Hib); ≥0.35 μg/mL (Pneumococcal antigens, PnC); and ≥10 mIU/mL (Hepatitis B), evaluated using enzyme-linked immunosorbent assay (ELISA) at one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age. The immune response to pertussis antigens (PT, FHA, Pertactin, FIM) was measured as percentage of subjects with seroresponse (in initially seronegative infants, ≥4 times the lower limit of quantification (LLQ); in initially seropositive infants, at least 4 times prevaccination concentration) by ELISA and percentage of subjects with titer ≥1:8 (Polio types 1, 2, and 3) by neutralization test (NT) one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age.

Time frame: One month after third dose of routine infant series vaccination

Population: Analysis was performed on the PP concomitant, pertussis and hepatitis B infant populations.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Diphtheria (≥0.1 IU/mL) (N=207,218)	99 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Tetanus (≥0.1 IU/mL) (N=207,218)	97 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PT (N=185,191)	77 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	FHA (N=185,191)	70 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Pertactin (N=185,191)	73 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	FIM (N=185,191)	74 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Polio Type 1 - ≥1:8 (N=115,113)	99 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Polio Type 2 - ≥1:8 (N=185,179)	100 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Polio Type 3 - ≥1:8 (N=164,162)	99 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Hepatitis B - ≥10 mIU/mL (N=138,148)	96 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PRP-Hib - ≥0.15 μg/mL (N=187,194)	95 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 4 - ≥0.35 μg/mL (N=183,178)	99 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 6B - ≥0.35 μg/mL (N=183,178)	86 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 9V - ≥0.35 μg/mL (N=183,178)	91 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 14 - ≥0.35 μg/mL (N=183,178)	99 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 18C - ≥0.35 μg/mL (N=183,178)	95 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 19F - ≥0.35 μg/mL (N=183,178)	100 Percentage of subjects
MenACWY-CRM + Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 23F - ≥0.35 μg/mL (N=183,178)	89 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 9V - ≥0.35 μg/mL (N=183,178)	94 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Diphtheria (≥0.1 IU/mL) (N=207,218)	99 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Hepatitis B - ≥10 mIU/mL (N=138,148)	97 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Tetanus (≥0.1 IU/mL) (N=207,218)	97 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 23F - ≥0.35 μg/mL (N=183,178)	94 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PT (N=185,191)	81 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PRP-Hib - ≥0.15 μg/mL (N=187,194)	89 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	FHA (N=185,191)	65 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 14 - ≥0.35 μg/mL (N=183,178)	99 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Pertactin (N=185,191)	73 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 4 - ≥0.35 μg/mL (N=183,178)	98 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	FIM (N=185,191)	76 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 19F - ≥0.35 μg/mL (N=183,178)	97 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Polio Type 1 - ≥1:8 (N=115,113)	98 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 6B - ≥0.35 μg/mL (N=183,178)	90 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Polio Type 2 - ≥1:8 (N=185,179)	99 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	PnC 18C - ≥0.35 μg/mL (N=183,178)	97 Percentage of subjects
Routine Vaccines	Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone	Polio Type 3 - ≥1:8 (N=164,162)	100 Percentage of subjects

Comparison: To demonstrate the non-inferiority of seroresponse to diphtheria toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone95% CI: [-2.9, 2.6]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to tetanus toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone95% CI: [-3.3, 3.9]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to pertussis toxin (PT), when DTaP vaccine is given, compared with MenACWY-CRM compared with when DTaP vaccine is given alone95% CI: [-12.1, 4.3]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to pertussis FHA antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone95% CI: [-5.1, 13.6]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to pertussis pertactin antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP is given alone.95% CI: [-8.8, 9.1]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to pertussis FIM antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone95% CI: [-10.6, 6.8]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to hepatitis B antigen, when hepatitis B vaccine is given with MenACWY-CRM compared with when hepatitis B vaccine is given alone.95% CI: [-5.2, 4.5]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to Hib antigen, when Hib vaccine is given with MenACWY-CRM compared with when Hib vaccine is given alone.95% CI: [0, 11.2]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to polio antigen (Type 1), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone95% CI: [-3.1, 5.4]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to polio antigen (Type 2), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone95% CI: [-1.4, 3]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to polio antigen (Type 3), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone95% CI: [-3.3, 1.7]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 4 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone95% CI: [-1.9, 4.6]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 6B antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone95% CI: [-10.3, 3.2]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 9V antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone95% CI: [-8.7, 2.3]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 14 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone95% CI: [-2.8, 3]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 18C antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone95% CI: [-7.3, 1.6]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 19F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone95% CI: [1.3, 7.1]Miettinen and Nurminen

Comparison: To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 23F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone95% CI: [-11.4, 0.5]Miettinen and Nurminen

Secondary

Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination

The antibody persistence was measured as the hSBA GMTs directed against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.

Time frame: Baseline and Six months after third infant dose of MenACWY-CRM

Population: Analysis was performed on the PP toddler dataset for MenACWY-CRM.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM + Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup A - Baseline (N=139, 145)	2.07 Titers
MenACWY-CRM + Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup A - 6 mo Post-3rd dose (N=168,175)	2.52 Titers
MenACWY-CRM + Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup C - Baseline (N=126,136)	2.49 Titers
MenACWY-CRM + Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup C - 6 mo Post-3rd dose (N=156,171)	5.98 Titers
MenACWY-CRM + Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup W - Baseline (N=113,126)	2.99 Titers
MenACWY-CRM + Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup W - 6 mo Post-3rd dose (N=153,165)	15 Titers
MenACWY-CRM + Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup Y - Baseline (N=108,113)	2.43 Titers
MenACWY-CRM + Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup Y - 6 mo Post-3rd dose (N=153,159)	8.39 Titers
Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup Y - 6 mo Post-3rd dose (N=153,159)	2.09 Titers
Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup A - Baseline (N=139, 145)	2.01 Titers
Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup W - Baseline (N=113,126)	2.97 Titers
Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup A - 6 mo Post-3rd dose (N=168,175)	2.12 Titers
Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup Y - Baseline (N=108,113)	2.32 Titers
Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup C - Baseline (N=126,136)	2.44 Titers
Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup W - 6 mo Post-3rd dose (N=153,165)	2.23 Titers
Routine Vaccines	Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination	Serogroup C - 6 mo Post-3rd dose (N=156,171)	2.15 Titers

Secondary

Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations

Safety of the study vaccines (MenACWY-CRM and other routine vaccines) was assessed in terms of the number of subjects who reported adverse events (AEs) and/or serious AEs per vaccine group at the following time points: entire study period, after infants vaccination (up to 7 months), between 2- and 4-months, between 4- and 6-months, between 6- and 12-months, between 7- and 12-months, 28 days after 12-month vaccination, and between 29 days after 12-month vaccination and study termination. Solicited reactions were not collected during this study. The safety analyses also included any AEs observed by study personnel within 15 minutes following vaccination. All AEs and SAEs were judged by the investigator as whether probably related, possibly related, or not related to vaccine.

Time frame: From day 1 to 18 months

Population: Analysis was performed on the safety dataset, i.e. all subjects in the exposed population who provided postbaseline safety data

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 2- and 4-months - Any AEs	99 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Entire study - At least possibly related AEs	6 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Entire study - Serious AEs	21 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Up to 7 months - Any AEs	183 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Up to 7 months - At least possibly related AEs	6 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Up to 7 months - Serious AEs	7 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Entire study - Any AEs	228 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 2- & 4-mo - At least possibly related AEs	1 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 2- and 4-months - Serious AEs	5 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 4- and 6-months - Any AEs	118 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 4- & 6-mo - At least possibly related AEs	3 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 4- and 6-months - Serious AEs	2 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 6- and 12-months - Any AEs	187 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 6- & 12-mo - At least possibly related AEs	2 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 6- and 12-months - Serious AEs	10 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 7- and 12-months - Any AEs	175 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 7- & 12-mo - At least possibly related AEs	0 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 7- and 12-months - Serious AEs	9 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	28 days post-toddler - Any AEs	80 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	28 days post-toddler-At least possibly related AEs	0 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	28 days post-toddler - Serious AEs	1 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 29 days and study termination - Any AEs	137 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	B/w 29 days & study terminat-Possibly related AEs	0 Number of subjects
MenACWY-CRM + Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 29 days and study termination - SeriousAEs	7 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	B/w 29 days & study terminat-Possibly related AEs	0 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Entire study - Any AEs	239 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 6- and 12-months - Any AEs	197 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Entire study - At least possibly related AEs	2 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	28 days post-toddler - Any AEs	78 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Entire study - Serious AEs	20 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 6- & 12-mo - At least possibly related AEs	1 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Up to 7 months - Any AEs	189 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 29 days and study termination - Any AEs	137 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Up to 7 months - At least possibly related AEs	1 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 6- and 12-months - Serious AEs	2 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Up to 7 months - Serious AEs	8 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	28 days post-toddler-At least possibly related AEs	0 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 2- and 4-months - Any AEs	105 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 7- and 12-months - Any AEs	181 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 2- & 4-mo - At least possibly related AEs	0 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 29 days and study termination - SeriousAEs	11 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 2- and 4-months - Serious AEs	5 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 7- & 12-mo - At least possibly related AEs	0 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 4- and 6-months - Any AEs	114 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	28 days post-toddler - Serious AEs	1 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 4- & 6-mo - At least possibly related AEs	0 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 7- and 12-months - Serious AEs	2 Number of subjects
Routine Vaccines	Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations	Between 4- and 6-months - Serious AEs	2 Number of subjects

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

A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM

Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination

Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone

Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone

hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM

hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM

Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone

Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM

Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM

Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone

Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination

Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations