Trial Outcomes & Findings for Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months) (NCT NCT00310856)

NCT ID: NCT00310856

Last Updated: 2018-10-09

Results Overview

Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM\_12 M group)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 175 participants
• Primary outcome timeframe: Before and 1 month after 2-dose or 1-dose schedule
• Results posted on: 2018-10-09

Participant Flow

Subjects were enrolled at three sites in Canada.

All enrolled subjects were included in the study.

Participant milestones

Measure	MenACWY-CRM_6-12 M Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).	MenACWY-CRM_12 M Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).	MenC-CRM_12 M_MenACWY-CRM_18 M Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).
Overall Study STARTED	64	61	50
Overall Study COMPLETED	59	56	42
Overall Study NOT COMPLETED	5	5	8

Reasons for withdrawal

Measure	MenACWY-CRM_6-12 M Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).	MenACWY-CRM_12 M Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).	MenC-CRM_12 M_MenACWY-CRM_18 M Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).
Overall Study Withdrawal by Subject	2	2	2
Overall Study Lost to Follow-up	1	2	6
Overall Study Inappropriate enrollment	1	1	0
Overall Study Unable to classify	1	0	0

Baseline Characteristics

Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)

Baseline characteristics by cohort

Measure	MenACWY-CRM_6-12 M n=64 Participants Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenACWY-CRM_12 M n=61 Participants Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenC-CRM_12 M_MenACWY-CRM_18 M n=50 Participants Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).	Total n=175 Participants Total of all reporting groups
Age, Continuous	6.0 Months STANDARD_DEVIATION 0.2 • n=5 Participants	6.0 Months STANDARD_DEVIATION 0.0 • n=7 Participants	12.1 Months STANDARD_DEVIATION 0.2 • n=5 Participants	7.7 Months STANDARD_DEVIATION 2.8 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	31 Participants n=7 Participants	21 Participants n=5 Participants	77 Participants n=4 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	30 Participants n=7 Participants	29 Participants n=5 Participants	98 Participants n=4 Participants

PRIMARY outcome

Timeframe: Before and 1 month after 2-dose or 1-dose schedule

Population: Analysis was done on per protocol (PP) population, i.e subjects in the exposed population who received all the relevant doses of vaccines correctly; and provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to unblinding.

Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM_12 M group)

Outcome measures

Measure	MenACWY-CRM_6-12 M n=55 Participants Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenACWY-CRM_12 M n=54 Participants Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenC-CRM_12 M_MenACWY-CRM_18 M Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup A - Prevaccination (N=50,53)	10 Percentage of subjects Interval 3.0 to 22.0	0 Percentage of subjects Interval 0.0 to 7.0	—
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup A - Postvaccination (N=50,53)	88 Percentage of subjects Interval 76.0 to 95.0	74 Percentage of subjects Interval 60.0 to 85.0	—
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup C - Prevaccination	85 Percentage of subjects Interval 73.0 to 94.0	2 Percentage of subjects Interval 0.047 to 10.0	—
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup C - Postvaccination	100 Percentage of subjects Interval 94.0 to 100.0	96 Percentage of subjects Interval 87.0 to 100.0	—
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup W - Prevaccination (N=40,41)	85 Percentage of subjects Interval 70.0 to 94.0	2 Percentage of subjects Interval 0.062 to 13.0	—
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup W - Postvaccination (N=40,41)	100 Percentage of subjects Interval 91.0 to 100.0	95 Percentage of subjects Interval 83.0 to 99.0	—
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup Y - Prevaccination (N=53,54)	72 Percentage of subjects Interval 58.0 to 83.0	0 Percentage of subjects Interval 0.0 to 7.0	—
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup Y - Postvaccination (N=53,54)	100 Percentage of subjects Interval 93.0 to 100.0	78 Percentage of subjects Interval 64.0 to 88.0	—

SECONDARY outcome

Timeframe: Before and 1 month after 2-dose or 1-dose schedule

Population: Analysis was done on PP population.

The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M group)

Outcome measures

Measure	MenACWY-CRM_6-12 M n=55 Participants Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenACWY-CRM_12 M n=54 Participants Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenC-CRM_12 M_MenACWY-CRM_18 M Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).
Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup A - Prevaccination (N=50,53)	2.41 Geometric mean titers Interval 2.18 to 2.65	1.99 Geometric mean titers Interval 1.81 to 2.19	—
Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup W - Prevaccination (N=40,41)	15 Geometric mean titers Interval 12.0 to 19.0	2.09 Geometric mean titers Interval 1.68 to 2.6	—
Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup A - Postvaccination (N=50,53)	44 Geometric mean titers Interval 29.0 to 65.0	11 Geometric mean titers Interval 7.55 to 16.0	—
Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup C - Prevaccination	19 Geometric mean titers Interval 14.0 to 25.0	2.06 Geometric mean titers Interval 1.54 to 2.77	—
Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup C - Postvaccination	302 Geometric mean titers Interval 224.0 to 405.0	40 Geometric mean titers Interval 30.0 to 54.0	—
Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup W-Postvaccination (N=40,41)	220 Geometric mean titers Interval 155.0 to 313.0	30 Geometric mean titers Interval 21.0 to 43.0	—
Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup Y - Prevaccination	7.91 Geometric mean titers Interval 6.64 to 9.43	2.02 Geometric mean titers Interval 1.7 to 2.4	—
Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup Y - Postvaccination	136 Geometric mean titers Interval 100.0 to 185.0	10 Geometric mean titers Interval 7.68 to 14.0	—

SECONDARY outcome

Timeframe: Before and 1 month after 2-dose or 1-dose schedule

Population: Analysis was done on PP population.

Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M)

Outcome measures

Measure	MenACWY-CRM_6-12 M n=55 Participants Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenACWY-CRM_12 M n=54 Participants Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenC-CRM_12 M_MenACWY-CRM_18 M Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup C - Prevaccination	75 Percentage of subjects Interval 61.0 to 85.0	2 Percentage of subjects Interval 0.047 to 10.0	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup C - Postvaccination	100 Percentage of subjects Interval 94.0 to 100.0	93 Percentage of subjects Interval 82.0 to 98.0	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup A - Prevaccination (N=50,53)	8 Percentage of subjects Interval 2.0 to 19.0	0 Percentage of subjects Interval 0.0 to 7.0	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup A - Postvaccination (N=50,53)	84 Percentage of subjects Interval 71.0 to 93.0	60 Percentage of subjects Interval 46.0 to 74.0	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup W - Prevaccination (N=40,41)	73 Percentage of subjects Interval 56.0 to 85.0	2 Percentage of subjects Interval 0.062 to 13.0	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup W - Postvaccination (N=40,41)	100 Percentage of subjects Interval 91.0 to 100.0	93 Percentage of subjects Interval 80.0 to 98.0	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup Y - Prevaccination (N=53,54)	55 Percentage of subjects Interval 40.0 to 68.0	0 Percentage of subjects Interval 0.0 to 7.0	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule Serogroup Y - Postvaccination (N=53,54)	100 Percentage of subjects Interval 93.0 to 100.0	67 Percentage of subjects Interval 53.0 to 79.0	—

SECONDARY outcome

Timeframe: Before and 1 month after MenC-CRM vaccination at 12 months

Population: Analysis was done on PP population.

Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age

Outcome measures

Measure	MenACWY-CRM_6-12 M n=40 Participants Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenACWY-CRM_12 M Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenC-CRM_12 M_MenACWY-CRM_18 M Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age hSBA titers ≥1:8 - Postvaccination	88 Percentage of subjects Interval 73.0 to 96.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age hSBA titers ≥1:4 - Prevaccination	0 Percentage of subjects Interval 0.0 to 9.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age hSBA titers ≥1:4 - Postvaccination	93 Percentage of subjects Interval 80.0 to 98.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age hSBA titers ≥1:8 - Prevaccination	0 Percentage of subjects Interval 0.0 to 9.0	—	—

SECONDARY outcome

Timeframe: Before and 1 month after MenC-CRM vaccination at 12 months

Population: Analysis was done on PP population.

The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age

Outcome measures

Measure	MenACWY-CRM_6-12 M n=40 Participants Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenACWY-CRM_12 M Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenC-CRM_12 M_MenACWY-CRM_18 M Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).
Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age hSBA GMTs - Prevaccination	2 Geometric mean titers Interval 1.81 to 2.21	—	—
Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age hSBA GMTs - Postvaccination	39 Geometric mean titers Interval 29.0 to 52.0	—	—

SECONDARY outcome

Timeframe: Before and 1 month after MenACWY-CRM vaccination at 18 months

Population: Analysis was done on PP population.

Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age

Outcome measures

Measure	MenACWY-CRM_6-12 M n=38 Participants Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenACWY-CRM_12 M Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenC-CRM_12 M_MenACWY-CRM_18 M Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup A - hSBA ≥1:4 - Prevaccination	0 Percentage of subjects Interval 0.0 to 9.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup A - hSBA ≥1:4 - Postvaccination	63 Percentage of subjects Interval 46.0 to 78.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup W - hSBA ≥1:4 - Prevaccination (N=37)	3 Percentage of subjects Interval 0.068 to 14.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup W - hSBA ≥1:4 - Postvaccination (N=37)	81 Percentage of subjects Interval 65.0 to 92.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup Y - hSBA ≥1:4 - Prevaccination	0 Percentage of subjects Interval 0.0 to 9.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup Y - hSBA ≥1:4 - Postvaccination	79 Percentage of subjects Interval 63.0 to 90.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup A - hSBA ≥1:8 - Prevaccination	0 Percentage of subjects Interval 0.0 to 9.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup A - hSBA ≥1:8 - Postvaccination	50 Percentage of subjects Interval 33.0 to 67.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup W - hSBA ≥1:8 - Prevaccination (N=37)	3 Percentage of subjects Interval 0.068 to 14.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup W - hSBA ≥1:8 - Postvaccination (N=37)	76 Percentage of subjects Interval 59.0 to 88.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup Y - hSBA ≥1:8 - Prevaccination	0 Percentage of subjects Interval 0.0 to 9.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup Y - hSBA ≥1:8 - Postvaccination	63 Percentage of subjects Interval 46.0 to 78.0	—	—

SECONDARY outcome

Timeframe: Before and 1 month after MenACWY-CRM vaccination at 18 months

Population: Analysis was done on PP population.

The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age

Outcome measures

Measure	MenACWY-CRM_6-12 M n=38 Participants Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenACWY-CRM_12 M Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenC-CRM_12 M_MenACWY-CRM_18 M Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).
hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup A - Prevaccination	2 Geometric mean titers Interval 1.78 to 2.24	—	—
hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup A - Postvaccination	8.05 Geometric mean titers Interval 5.11 to 13.0	—	—
hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup W - Prevaccination (N=37)	2.09 Geometric mean titers Interval 1.66 to 2.64	—	—
hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup W - Postvaccination (N=37)	17 Geometric mean titers Interval 12.0 to 24.0	—	—
hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup Y - Prevaccination	2 Geometric mean titers Interval 1.62 to 2.45	—	—
hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age Serogroup Y - Postvaccination	13 Geometric mean titers Interval 8.78 to 18.0	—	—

SECONDARY outcome

Timeframe: Before and 1 month after MenACWY-CRM vaccination at 18 months

Population: Analysis was done on PP population.

Booster response was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age

Outcome measures

Measure	MenACWY-CRM_6-12 M n=38 Participants Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenACWY-CRM_12 M Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenC-CRM_12 M_MenACWY-CRM_18 M Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age hSBA ≥1:4 - Prevaccination	89 Percentage of subjects Interval 75.0 to 97.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age hSBA ≥1:4 - Postvaccination	100 Percentage of subjects Interval 91.0 to 100.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age hSBA ≥1:8 - Prevaccination	82 Percentage of subjects Interval 66.0 to 92.0	—	—
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age hSBA ≥1:8 - Postvaccination	100 Percentage of subjects Interval 91.0 to 100.0	—	—

SECONDARY outcome

Timeframe: Before and 1 month after MenACWY-CRM vaccination at 18 months

Population: Analysis was done on PP population.

Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age

Outcome measures

Measure	MenACWY-CRM_6-12 M n=38 Participants Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenACWY-CRM_12 M Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenC-CRM_12 M_MenACWY-CRM_18 M Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).
hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age hSBA GMTs - Prevaccination	29 Geometric mean titers Interval 20.0 to 41.0	—	—
hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age hSBA GMTs - Postvaccination	667 Geometric mean titers Interval 467.0 to 952.0	—	—

SECONDARY outcome

Timeframe: From day 1 through day 7 after any vaccination

Population: Analysis was done on the safety population, i.e. all subjects who had at least one vaccination and some postbaseline safety data.

The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination

Outcome measures

Measure	MenACWY-CRM_6-12 M n=64 Participants Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenACWY-CRM_12 M n=61 Participants Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).	MenC-CRM_12 M_MenACWY-CRM_18 M n=50 Participants Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination Any local reactions	53 participants	49 participants	47 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination MenACWY MenC Tenderness (N=64,56,50)	25 participants	24 participants	30 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination MenACWY MenC Erythema (N=64,56,50)	33 participants	25 participants	28 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination MenACWY MenC Induration (N=64,56,50)	29 participants	20 participants	23 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination DTaP-Hib-IPV Tenderness (N=64,61,44)	23 participants	22 participants	27 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination DTaP-Hib-IPV Erythema (N=64,61,44)	33 participants	25 participants	23 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination DTaP-Hib-IPV Induration (N=64,61,44)	28 participants	20 participants	17 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination PCV7 Tenderness	32 participants	33 participants	16 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination PC7 Erythema	39 participants	31 participants	28 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination PC7 Induration	31 participants	32 participants	19 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination Any systemic reactions	59 participants	55 participants	43 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination Change in eating habits (N=62,60,50)	28 participants	21 participants	21 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination Sleepiness	35 participants	32 participants	22 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination Irritability	57 participants	45 participants	38 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination Vomiting	9 participants	11 participants	6 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination Diarrhea	12 participants	18 participants	11 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination Fever (≥38 °C)	6 participants	12 participants	12 participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination Analgesic Antipyretic Medicines Used	42 participants	35 participants	29 participants

Adverse Events

MenACWY-CRM_6-12M

Serious events: 3 serious events

Other events: 62 other events

Deaths: 0 deaths

MenACWY-CRM_12M

Serious events: 2 serious events

Other events: 58 other events

Deaths: 0 deaths

MenC-CRM_12M_MenACWY-CRM_18M

Serious events: 2 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Measure	MenACWY-CRM_6-12M n=64 participants at risk Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)	MenACWY-CRM_12M n=61 participants at risk Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)	MenC-CRM_12M_MenACWY-CRM_18M n=50 participants at risk Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib- IPV (at 18 months)
Infections and infestations Bronchiolitis	1.6% 1/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	1.6% 1/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	0.00% 0/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
Infections and infestations Infectious mononucleosis	0.00% 0/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	0.00% 0/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	2.0% 1/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
Infections and infestations Pneumonia	0.00% 0/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	1.6% 1/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	0.00% 0/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
Infections and infestations Respiratory syncytial virus infection	1.6% 1/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	0.00% 0/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	0.00% 0/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
Infections and infestations Urinary tract infection	0.00% 0/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	1.6% 1/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	0.00% 0/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
Nervous system disorders Lethargy	1.6% 1/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	0.00% 0/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	0.00% 0/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	1.6% 1/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	2.0% 1/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)

Other adverse events

Measure	MenACWY-CRM_6-12M n=64 participants at risk Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)	MenACWY-CRM_12M n=61 participants at risk Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)	MenC-CRM_12M_MenACWY-CRM_18M n=50 participants at risk Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib- IPV (at 18 months)
Gastrointestinal disorders Diarrhoea	18.8% 12/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	29.5% 18/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	26.0% 13/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
Gastrointestinal disorders Vomiting	14.1% 9/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	18.0% 11/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	14.0% 7/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
General disorders Injection site erythema	64.1% 41/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	54.1% 33/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	78.0% 39/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
General disorders Injection site induration	59.4% 38/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	57.4% 35/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	62.0% 31/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
General disorders Injection site pain	56.2% 36/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	57.4% 35/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	68.0% 34/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
General disorders Irritability	89.1% 57/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	73.8% 45/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	76.0% 38/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
General disorders Pyrexia	9.4% 6/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	23.0% 14/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	26.0% 13/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
Infections and infestations Nasopharyngitis	9.4% 6/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	8.2% 5/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	8.0% 4/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
Nervous system disorders Somnolence	54.7% 35/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	52.5% 32/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	44.0% 22/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
Psychiatric disorders Eating disorder	43.8% 28/64 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	34.4% 21/61 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)	42.0% 21/50 • Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: RegistryContactVaccinesUS@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single site are postponed until the publication of the pool data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER