Trial Outcomes & Findings for Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine (NCT NCT01345721)

Last Updated: 2018-06-18

Results Overview

The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported. The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

205 participants

Primary outcome timeframe

From 13-33 months post last vaccination in parent study (V59P22)

Results posted on

2018-06-18

Participant Flow

Subjects for this extension study were enrolled from only sites in Germany that participated in the parent study.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	MenACWY (2 Primary + 1 Booster Dose) Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) + MenACWY (1 Booster Dose) Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Overall Study STARTED	74	66	65
Overall Study COMPLETED	74	66	65
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenACWY (2 Primary +1 Booster Dose) n=74 Participants Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) n=66 Participants Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) n=65 Participants Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.	Total n=205 Participants Total of all reporting groups
Age, Continuous	36.7 months STANDARD_DEVIATION 5.3 • n=5 Participants	37.4 months STANDARD_DEVIATION 5.6 • n=7 Participants	37.9 months STANDARD_DEVIATION 5.3 • n=5 Participants	37.3 months STANDARD_DEVIATION 5.4 • n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	30 Participants n=7 Participants	37 Participants n=5 Participants	101 Participants n=4 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	36 Participants n=7 Participants	28 Participants n=5 Participants	104 Participants n=4 Participants

PRIMARY outcome

Timeframe: From 13-33 months post last vaccination in parent study (V59P22)

Population: The analysis was done on the per-protocol persistence dataset i.e all enrolled subjects who provided evaluable serum samples at day 1 of the study and had no major protocol violation as defined prior to the end of the study.

Outcome measures

Outcome measures
Measure	MenACWY (2 Primary + 1 Booster Dose) n=52 Participants Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) n=41 Participants Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) n=43 Participants Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine 13-33 months persistence (Serogroup A)	13 Percentages of subjects Interval 6.0 to 26.0	7 Percentages of subjects Interval 2.0 to 20.0	0 Percentages of subjects Interval 0.0 to 8.0
Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine 13-33 months persistence (Serogroup C)(N=52,40,42)	27 Percentages of subjects Interval 16.0 to 41.0	25 Percentages of subjects Interval 13.0 to 41.0	36 Percentages of subjects Interval 22.0 to 52.0
Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine 13-33 months persistence (Serogroup W-135)	50 Percentages of subjects Interval 36.0 to 64.0	63 Percentages of subjects Interval 47.0 to 78.0	12 Percentages of subjects Interval 4.0 to 25.0
Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine 13-33 months persistence (Serogroup Y)	40 Percentages of subjects Interval 27.0 to 55.0	39 Percentages of subjects Interval 24.0 to 55.0	19 Percentages of subjects Interval 8.0 to 33.0

PRIMARY outcome

Timeframe: 1 month post booster

Population: The analysis was done on the per-protocol dataset i.e All enrolled subjects who correctly received the vaccine, provided evaluable serum samples at the relevant time points (Day 28),and had no major protocol violation as defined prior to the end of the study.

The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.

Outcome measures

Outcome measures
Measure	MenACWY (2 Primary + 1 Booster Dose) n=52 Participants Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) n=41 Participants Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination Pre-booster (Serogroup A)	13 Percentages of subjects Interval 6.0 to 26.0	7 Percentages of subjects Interval 2.0 to 20.0	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination 1 month post booster (Serogroup A)	96 Percentages of subjects Interval 87.0 to 100.0	98 Percentages of subjects Interval 87.0 to 100.0	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination Pre-booster (Serogroup C) N=52,40	27 Percentages of subjects Interval 16.0 to 41.0	25 Percentages of subjects Interval 13.0 to 41.0	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination 1 month post booster (Serogroup C) N=52,40	100 Percentages of subjects Interval 93.0 to 100.0	100 Percentages of subjects Interval 91.0 to 100.0	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination Pre-booster (Serogroup W-135)	50 Percentages of subjects Interval 36.0 to 64.0	63 Percentages of subjects Interval 47.0 to 78.0	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination 1 month post booster (Serogroup W-135)	100 Percentages of subjects Interval 93.0 to 100.0	100 Percentages of subjects Interval 91.0 to 100.0	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination Pre-booster (Serogroup Y)	40 Percentages of subjects Interval 27.0 to 55.0	39 Percentages of subjects Interval 24.0 to 55.0	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination 1 month post booster (Serogroup Y)	100 Percentages of subjects Interval 93.0 to 100.0	100 Percentages of subjects Interval 91.0 to 100.0	—

PRIMARY outcome

Timeframe: 1 month post booster vaccination

Population: The analysis was done on the per-protocol dataset.

The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.

Outcome measures

Outcome measures
Measure	MenACWY (2 Primary + 1 Booster Dose) n=52 Participants Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) n=41 Participants Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination 1 month post booster (Serogroup A)	182 Titers Interval 118.0 to 281.0	214 Titers Interval 131.0 to 350.0	—
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination Pre-booster (Serogroup A)	2.82 Titers Interval 2.35 to 3.38	2.52 Titers Interval 2.05 to 3.09	—
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination Pre-booster (Serogroup C) N=52,40	3.92 Titers Interval 2.92 to 5.26	3.91 Titers Interval 2.79 to 5.48	—
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination 1 month post booster (Serogroup C) N=52,40	541 Titers Interval 399.0 to 733.0	968 Titers Interval 682.0 to 1372.0	—
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination Pre-booster (Serogroup W-135)	9.37 Titers Interval 6.3 to 14.0	12 Titers Interval 7.51 to 18.0	—
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination 1 month post booster (Serogroup W-135)	799 Titers Interval 564.0 to 1133.0	1267 Titers Interval 854.0 to 1879.0	—
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination Pre-booster (Serogroup Y)	6.79 Titers Interval 4.86 to 9.5	6.04 Titers Interval 4.13 to 8.82	—
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination 1 month post booster (Serogroup Y)	650 Titers Interval 448.0 to 941.0	676 Titers Interval 444.0 to 1027.0	—

PRIMARY outcome

Timeframe: 1 month after vaccination

Population: The analysis was done on the per-protocol dataset.

The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y

Outcome measures

Outcome measures
Measure	MenACWY (2 Primary + 1 Booster Dose) n=41 Participants Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination Pre-vaccination (Serogroup A)	0 Percentages of subjects Interval 0.0 to 9.0	—	—
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination 1 month post vaccination (Serogroup A)	61 Percentages of subjects Interval 45.0 to 76.0	—	—
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination Pre-vaccination (Serogroup C) N=39	36 Percentages of subjects Interval 21.0 to 53.0	—	—
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination 1 month post vaccination (Serogroup C) N=39	100 Percentages of subjects Interval 91.0 to 100.0	—	—
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination Pre-vaccination (Serogroup W-135)	12 Percentages of subjects Interval 4.0 to 26.0	—	—
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination 1 month post vaccination (Serogroup W-135)	95 Percentages of subjects Interval 83.0 to 99.0	—	—
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination Pre-vaccination (Serogroup Y)	20 Percentages of subjects Interval 9.0 to 35.0	—	—
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination 1 month post vaccination (Serogroup Y)	95 Percentages of subjects Interval 83.0 to 99.0	—	—

PRIMARY outcome

Timeframe: 1 month post vaccination

Population: The analysis was done on the per-protocol dataset.

The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y

Outcome measures

Outcome measures
Measure	MenACWY (2 Primary + 1 Booster Dose) n=41 Participants Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine Pre-vaccination (Serogroup A)	2 Titers Interval 1.63 to 2.45	—	—
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine 1 month post vaccination (Serogroup A)	20 Titers Interval 12.0 to 32.0	—	—
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine Pre-vaccination (Serogroup C) N=39	4.83 Titers Interval 3.44 to 6.77	—	—
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine 1 month post vaccination (Serogroup C) N=39	1530 Titers Interval 1077.0 to 2173.0	—	—
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine Pre-vaccination (Serogroup W-135)	2.82 Titers Interval 1.81 to 4.39	—	—
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine 1 month post vaccination (Serogroup W-135)	54 Titers Interval 37.0 to 80.0	—	—
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine Pre-vaccination (Serogroup Y)	3.05 Titers Interval 2.09 to 4.44	—	—
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine 1 month post vaccination (Serogroup Y)	54 Titers Interval 35.0 to 81.0	—	—

SECONDARY outcome

Timeframe: From 13-33 months post last vaccination in parent study (V59P22)

Population: The analysis was done on the per-protocol persistence dataset.

The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y

Outcome measures

Outcome measures
Measure	MenACWY (2 Primary + 1 Booster Dose) n=52 Participants Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) n=41 Participants Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) n=43 Participants Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine 13-33 months persistence (Serogroup C) N=52,40	3.94 Titers Interval 2.92 to 5.3	3.93 Titers Interval 2.79 to 5.53	4.94 Titers Interval 3.55 to 6.86
Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine 13-33 months persistence (Serogroup A)	2.82 Titers Interval 2.36 to 3.37	2.52 Titers Interval 2.05 to 3.08	2 Titers Interval 1.64 to 2.43
Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine 13-33 months persistence (Serogroup W-135)	9.36 Titers Interval 6.31 to 14.0	12 Titers Interval 7.53 to 18.0	2.81 Titers Interval 1.82 to 4.32
Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine 13-33 months persistence (Serogroup Y)	6.79 Titers Interval 4.87 to 9.47	6.03 Titers Interval 4.14 to 8.78	2.99 Titers Interval 2.08 to 4.3

SECONDARY outcome

Timeframe: 1 month post vaccination

Population: The analysis was done on the per-protocol dataset

Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y

Outcome measures

Outcome measures
Measure	MenACWY (2 Primary + 1 Booster Dose) n=41 Participants Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) n=41 Participants Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine hSBA ≥1:8(Serogroup A)	98 Percentages of subjects Interval 87.0 to 100.0	61 Percentages of subjects Interval 45.0 to 76.0	—
Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine hSBA ≥1:8 (Serogroup C) N=40,39	100 Percentages of subjects Interval 91.0 to 100.0	100 Percentages of subjects Interval 91.0 to 100.0	—
Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine hSBA ≥1:8(Serogroup W-135)	100 Percentages of subjects Interval 91.0 to 100.0	95 Percentages of subjects Interval 83.0 to 99.0	—
Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine hSBA ≥1:8 (Serogroup Y)	100 Percentages of subjects Interval 91.0 to 100.0	95 Percentages of subjects Interval 83.0 to 99.0	—

SECONDARY outcome

Timeframe: 1 month post vaccination

Population: The analysis was done on the per-protocol dataset

Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y

Outcome measures

Outcome measures
Measure	MenACWY (2 Primary + 1 Booster Dose) n=41 Participants Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) n=41 Participants Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine 1 month post vaccination (Serogroup A)	214 Titers Interval 131.0 to 350.0	20 Titers Interval 12.0 to 32.0	—
Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine 1 month post vaccination (Serogroup C) N=40,39	968 Titers Interval 682.0 to 1372.0	1530 Titers Interval 1077.0 to 2173.0	—
Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine 1 month post vaccination (Serogroup W-135)	1267 Titers Interval 854.0 to 1879.0	54 Titers Interval 37.0 to 80.0	—
Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine 1 month post vaccination (Serogroup Y)	676 Titers Interval 444.0 to 1027.0	54 Titers Interval 35.0 to 81.0	—

SECONDARY outcome

Timeframe: Day 1-7 after vaccination

Population: The analysis was done on the safety dataset i.e all subjects who received the study vaccine and provided some post-vaccination safety data

The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.

Outcome measures

Outcome measures
Measure	MenACWY (2 Primary + 1 Booster Dose) n=53 Participants Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) n=44 Participants Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) n=43 Participants Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Any Solicited Local	33 Participants	30 Participants	30 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Injection site pain	10 Participants	15 Participants	13 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Injection site erythema	14 Participants	17 Participants	15 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Injection site induration	6 Participants	8 Participants	7 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Any Solicited Systemic	28 Participants	18 Participants	25 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Arthralgia	1 Participants	5 Participants	4 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Headache	5 Participants	6 Participants	1 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Vomiting	0 Participants	2 Participants	1 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Change in eating habits	6 Participants	8 Participants	6 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Rash	0 Participants	2 Participants	1 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Sleepiness	10 Participants	13 Participants	10 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Fever (≥38°C)	8 Participants	7 Participants	7 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Any other	5 Participants	7 Participants	5 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Stayed at home	4 Participants	5 Participants	2 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Analgesic Antipyretic Medication Used	4 Participants	6 Participants	5 Participants
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Temperature (≥40°C) (N= 52,41,41)	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1-28 after vaccination

Population: The analysis was done on the safety dataset.

The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.

Outcome measures

Outcome measures
Measure	MenACWY (2 Primary + 1 Booster Dose) n=53 Participants Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) n=44 Participants Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) n=43 Participants Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination Any AE	11 Participants	10 Participants	9 Participants
Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination At least possibly related AEs	0 Participants	2 Participants	1 Participants
Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination Serious AE	0 Participants	0 Participants	0 Participants
Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination AEs leading to premature withdrawal	0 Participants	0 Participants	0 Participants
Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination Deaths	0 Participants	0 Participants	0 Participants

Adverse Events

MenACWY (2 Primary + 1 Booster Dose)

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

MenACWY (1 Primary + 1 Booster Dose)

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

MenC (1 Primary Dose) + MenACWY (1 Booster Dose)

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MenACWY (2 Primary + 1 Booster Dose) n=53 participants at risk Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenACWY (1 Primary + 1 Booster Dose) n=44 participants at risk Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	MenC (1 Primary Dose) + MenACWY (1 Booster Dose) n=43 participants at risk Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Gastrointestinal disorders Diarrhoea	7.5% 4/53 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	4.5% 2/44 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	18.6% 8/43 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.
General disorders Injection site erythema	26.4% 14/53 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	38.6% 17/44 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	34.9% 15/43 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.
General disorders Injection site induration	11.3% 6/53 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	18.2% 8/44 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	16.3% 7/43 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.
General disorders Injection site pain	18.9% 10/53 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	34.1% 15/44 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	30.2% 13/43 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.
General disorders Irritability	22.6% 12/53 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	18.2% 8/44 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	32.6% 14/43 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.
General disorders Pyrexia	15.1% 8/53 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	18.2% 8/44 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	16.3% 7/43 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 1/53 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	11.4% 5/44 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	9.3% 4/43 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.
Nervous system disorders Headache	9.4% 5/53 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	13.6% 6/44 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	2.3% 1/43 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.
Nervous system disorders Somnolence	18.9% 10/53 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	29.5% 13/44 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	23.3% 10/43 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.
Psychiatric disorders Eating disorder	11.3% 6/53 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	18.2% 8/44 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.	14.0% 6/43 • Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28. Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60