Trial Outcomes & Findings for Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age (NCT NCT00329849)
NCT ID: NCT00329849
Last Updated: 2018-10-09
Results Overview
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine. Seroresponse was defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8; 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1500 participants
Primary outcome timeframe
1 month after vaccination (day 29)
Results posted on
2018-10-09
Participant Flow
Subjects were enrolled at 3 study centers in Argentina.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
MenACWY-CRM
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
|---|---|---|
|
Overall Study
STARTED
|
950
|
550
|
|
Overall Study
COMPLETED
|
944
|
546
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
MenACWY-CRM
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
Baseline Characteristics
Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age
Baseline characteristics by cohort
| Measure |
MenACWY-CRM
n=950 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS
n=550 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
Total
n=1500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.8 Years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
5.7 Years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
5.8 Years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
482 Participants
n=5 Participants
|
288 Participants
n=7 Participants
|
770 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
468 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
730 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month after vaccination (day 29)Population: Analysis was done on the per-protocol (PP) dataset of primary vaccination, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at one month after vaccination; and had no major protocol violations as defined in the analysis plan.
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine. Seroresponse was defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8; 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Outcome measures
| Measure |
MenACWY-CRM
n=148 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS
n=148 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
MenACWY-CRM_6 to 10 Years
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS_6 to 10 Years
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
|---|---|---|---|---|
|
Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A
|
93 Percentage of subjects
Interval 87.0 to 96.0
|
55 Percentage of subjects
Interval 46.0 to 63.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (N=147,144)
|
82 Percentage of subjects
Interval 74.0 to 88.0
|
52 Percentage of subjects
Interval 44.0 to 60.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (N=143,142)
|
74 Percentage of subjects
Interval 66.0 to 81.0
|
46 Percentage of subjects
Interval 37.0 to 54.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (N=146,146)
|
82 Percentage of subjects
Interval 74.0 to 87.0
|
63 Percentage of subjects
Interval 55.0 to 71.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to 7 postvaccinationPopulation: Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.
Outcome measures
| Measure |
MenACWY-CRM
n=950 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS
n=550 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
MenACWY-CRM_6 to 10 Years
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS_6 to 10 Years
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
|---|---|---|---|---|
|
Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination
|
11 Number of subjects
|
1 Number of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 29Population: Analysis was performed on the PP dataset of primary vaccination.
Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS.
Outcome measures
| Measure |
MenACWY-CRM
n=148 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS
n=148 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
MenACWY-CRM_6 to 10 Years
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS_6 to 10 Years
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
|---|---|---|---|---|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (hSBA ≥1:4)- Day 1 (N=147,144)
|
26 Percentage of subjects
Interval 19.0 to 34.0
|
31 Percentage of subjects
Interval 23.0 to 39.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (hSBA ≥1:4)- Day 29 (N=147,144)
|
91 Percentage of subjects
Interval 85.0 to 95.0
|
80 Percentage of subjects
Interval 72.0 to 86.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (hSBA ≥1:4)- Day 1 (N=143,142)
|
40 Percentage of subjects
Interval 32.0 to 48.0
|
37 Percentage of subjects
Interval 29.0 to 46.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (hSBA ≥1:4)- Day 29 (N=143,142)
|
99 Percentage of subjects
Interval 96.0 to 100.0
|
78 Percentage of subjects
Interval 70.0 to 85.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (hSBA ≥1:4)- Day 1 (N=146,146)
|
17 Percentage of subjects
Interval 11.0 to 24.0
|
15 Percentage of subjects
Interval 10.0 to 22.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (hSBA ≥1:4)- Day 29 (N=146,146)
|
90 Percentage of subjects
Interval 84.0 to 95.0
|
77 Percentage of subjects
Interval 69.0 to 83.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A (hSBA ≥1:8)- Day 1
|
4 Percentage of subjects
Interval 2.0 to 9.0
|
2 Percentage of subjects
Interval 0.0 to 6.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A (hSBA ≥1:8)- Day 29
|
95 Percentage of subjects
Interval 90.0 to 98.0
|
55 Percentage of subjects
Interval 47.0 to 64.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (hSBA ≥1:8)- Day 1 (N=147,144)
|
16 Percentage of subjects
Interval 10.0 to 23.0
|
20 Percentage of subjects
Interval 14.0 to 28.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (hSBA ≥1:8)- Day 29 (N=147,144)
|
88 Percentage of subjects
Interval 82.0 to 93.0
|
70 Percentage of subjects
Interval 62.0 to 77.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (hSBA ≥1:8)- Day 1 (N=143,142)
|
38 Percentage of subjects
Interval 30.0 to 46.0
|
35 Percentage of subjects
Interval 27.0 to 43.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (hSBA ≥1:8)- Day 29 (N=143,142)
|
99 Percentage of subjects
Interval 96.0 to 100.0
|
73 Percentage of subjects
Interval 64.0 to 80.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (hSBA ≥1:8)- Day 1 (N=146,146)
|
14 Percentage of subjects
Interval 9.0 to 21.0
|
11 Percentage of subjects
Interval 6.0 to 17.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (hSBA ≥1:8)- Day 29 (N=146,146)
|
89 Percentage of subjects
Interval 83.0 to 94.0
|
66 Percentage of subjects
Interval 58.0 to 74.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A (hSBA ≥1:4)- Day 1
|
5 Percentage of subjects
Interval 2.0 to 10.0
|
3 Percentage of subjects
Interval 1.0 to 8.0
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A (hSBA ≥1:4)- Day 29
|
95 Percentage of subjects
Interval 90.0 to 98.0
|
55 Percentage of subjects
Interval 47.0 to 64.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 29Population: Analysis was performed on the PP dataset of primary vaccination.
The immune response was measured as the hSBA geometric mean titers (GMTs) directed against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month(day 29) after one vaccination with MenACWY-CRM or MenACWY-PS.
Outcome measures
| Measure |
MenACWY-CRM
n=148 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS
n=148 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
MenACWY-CRM_6 to 10 Years
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS_6 to 10 Years
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
|---|---|---|---|---|
|
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A - Day 1
|
2.25 Geometric Mean Titers
Interval 2.1 to 2.41
|
2.09 Geometric Mean Titers
Interval 1.95 to 2.24
|
—
|
—
|
|
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A - Day 29
|
65 Geometric Mean Titers
Interval 51.0 to 82.0
|
11 Geometric Mean Titers
Interval 8.66 to 14.0
|
—
|
—
|
|
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (N=147,144) - Day 1
|
3.09 Geometric Mean Titers
Interval 2.69 to 3.53
|
3.27 Geometric Mean Titers
Interval 2.85 to 3.75
|
—
|
—
|
|
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (N=147,144) - Day 29
|
42 Geometric Mean Titers
Interval 32.0 to 54.0
|
20 Geometric Mean Titers
Interval 15.0 to 26.0
|
—
|
—
|
|
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (N=143,142) - Day 1
|
6.22 Geometric Mean Titers
Interval 4.9 to 7.9
|
5.40 Geometric Mean Titers
Interval 4.25 to 6.87
|
—
|
—
|
|
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (N=143,142) - Day 29
|
72 Geometric Mean Titers
Interval 56.0 to 92.0
|
20 Geometric Mean Titers
Interval 16.0 to 26.0
|
—
|
—
|
|
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (N=146,146) - Day 1
|
2.81 Geometric Mean Titers
Interval 2.48 to 3.19
|
2.64 Geometric Mean Titers
Interval 2.33 to 2.99
|
—
|
—
|
|
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (N=146,146) - Day 29
|
47 Geometric Mean Titers
Interval 35.0 to 63.0
|
25 Geometric Mean Titers
Interval 19.0 to 34.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 181Population: Analysis was performed on PP dataset for persistence analysis at day 181.
The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS.
Outcome measures
| Measure |
MenACWY-CRM
n=145 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS
n=144 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
MenACWY-CRM_6 to 10 Years
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS_6 to 10 Years
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
|---|---|---|---|---|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A(≥1:4)-Day 181(6 months postvaccination
|
39 Percentage of subjects
Interval 31.0 to 47.0
|
41 Percentage of subjects
Interval 33.0 to 49.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (hSBA ≥1:4) - Day 29 (N=141,139)
|
91 Percentage of subjects
Interval 85.0 to 95.0
|
79 Percentage of subjects
Interval 71.0 to 86.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (hSBA ≥1:4) - Day 181 (N=141,139)
|
87 Percentage of subjects
Interval 81.0 to 92.0
|
71 Percentage of subjects
Interval 63.0 to 79.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (hSBA ≥1:4) - Day 29 (N=137,137)
|
99 Percentage of subjects
Interval 96.0 to 100.0
|
78 Percentage of subjects
Interval 70.0 to 85.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A(≥1:4)-Day 29 (1 month postvaccination)
|
96 Percentage of subjects
Interval 91.0 to 98.0
|
54 Percentage of subjects
Interval 46.0 to 62.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (hSBA ≥1:4) - Day 181 (N=137,137)
|
97 Percentage of subjects
Interval 93.0 to 99.0
|
69 Percentage of subjects
Interval 60.0 to 76.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (hSBA ≥1:4) - Day 29 (N=140,141)
|
90 Percentage of subjects
Interval 84.0 to 94.0
|
77 Percentage of subjects
Interval 69.0 to 83.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (hSBA ≥1:4) - Day 181 (N=140,141)
|
94 Percentage of subjects
Interval 88.0 to 97.0
|
65 Percentage of subjects
Interval 56.0 to 72.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A (hSBA ≥1:8) - Day 29
|
95 Percentage of subjects
Interval 90.0 to 98.0
|
54 Percentage of subjects
Interval 46.0 to 62.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A (hSBA ≥1:8) - Day 181
|
35 Percentage of subjects
Interval 27.0 to 44.0
|
38 Percentage of subjects
Interval 30.0 to 47.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (hSBA ≥1:8) - Day 29 (N=141,139)
|
88 Percentage of subjects
Interval 81.0 to 93.0
|
70 Percentage of subjects
Interval 61.0 to 77.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (hSBA ≥1:8) - Day 181 (N=141,139)
|
81 Percentage of subjects
Interval 73.0 to 87.0
|
55 Percentage of subjects
Interval 47.0 to 64.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (hSBA ≥1:8) - Day 29 (N=137,137)
|
99 Percentage of subjects
Interval 96.0 to 100.0
|
72 Percentage of subjects
Interval 64.0 to 80.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (hSBA ≥1:8) - Day 181 (N=137,137)
|
96 Percentage of subjects
Interval 92.0 to 99.0
|
66 Percentage of subjects
Interval 57.0 to 74.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (hSBA ≥1:8) - Day 29 (N=140,141)
|
89 Percentage of subjects
Interval 82.0 to 93.0
|
67 Percentage of subjects
Interval 59.0 to 75.0
|
—
|
—
|
|
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (hSBA ≥1:8) - Day 181 (N=140,141)
|
89 Percentage of subjects
Interval 83.0 to 94.0
|
59 Percentage of subjects
Interval 50.0 to 67.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 181Population: Analysis was performed on the PP dataset for persistence analysis at day 181.
The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS
Outcome measures
| Measure |
MenACWY-CRM
n=145 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS
n=144 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
MenACWY-CRM_6 to 10 Years
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS_6 to 10 Years
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
|---|---|---|---|---|
|
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A - Day 29 (1 month post vaccination)
|
66 Geometric Mean Titers
Interval 52.0 to 83.0
|
11 Geometric Mean Titers
Interval 8.33 to 13.0
|
—
|
—
|
|
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup A - Day 181 (6 months post vaccination)
|
5.06 Geometric Mean Titers
Interval 4.05 to 6.33
|
5.85 Geometric Mean Titers
Interval 4.68 to 7.32
|
—
|
—
|
|
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (N=141,139) - Day 29
|
41 Geometric Mean Titers
Interval 31.0 to 54.0
|
20 Geometric Mean Titers
Interval 15.0 to 27.0
|
—
|
—
|
|
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup C (N=141,139) - Day 181
|
22 Geometric Mean Titers
Interval 17.0 to 28.0
|
11 Geometric Mean Titers
Interval 8.84 to 14.0
|
—
|
—
|
|
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (N=137,137) - Day 29
|
74 Geometric Mean Titers
Interval 58.0 to 95.0
|
21 Geometric Mean Titers
Interval 16.0 to 27.0
|
—
|
—
|
|
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup W (N=137,137) - Day 181
|
69 Geometric Mean Titers
Interval 54.0 to 89.0
|
16 Geometric Mean Titers
Interval 13.0 to 21.0
|
—
|
—
|
|
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (N=140,141) - Day 29
|
47 Geometric Mean Titers
Interval 35.0 to 64.0
|
26 Geometric Mean Titers
Interval 19.0 to 35.0
|
—
|
—
|
|
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Serogroup Y (N=140,141) - Day 181
|
39 Geometric Mean Titers
Interval 29.0 to 51.0
|
14 Geometric Mean Titers
Interval 11.0 to 19.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 7 postvaccinationPopulation: Analysis was performed on safety dataset. Groups were sub-divided into 2 to 5 years of age and 6 to 10 years of age.
Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS.
Outcome measures
| Measure |
MenACWY-CRM
n=452 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS
n=264 Participants
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
MenACWY-CRM_6 to 10 Years
n=498 Participants
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS_6 to 10 Years
n=286 Participants
Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
|---|---|---|---|---|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Myalgia
|
NA participants
This systemic reaction is not applicable to this age group
|
NA participants
This systemic reaction is not applicable to this age group
|
35 participants
|
25 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Any other AE
|
69 participants
|
42 participants
|
69 participants
|
47 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Axillary Temperature ≥38 °C
|
35 participants
|
18 participants
|
20 participants
|
16 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Analgesic/Antipyretic medicine used
|
69 participants
|
42 participants
|
69 participants
|
47 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Any local reaction
|
138 participants
|
99 participants
|
189 participants
|
125 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Injection site pain
|
89 participants
|
68 participants
|
132 participants
|
100 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Injection site erythema
|
75 participants
|
34 participants
|
91 participants
|
37 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Injection site induration
|
59 participants
|
23 participants
|
84 participants
|
38 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Any systemic reaction
|
130 participants
|
73 participants
|
119 participants
|
69 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Change in Eating Habits
|
36 participants
|
24 participants
|
NA participants
This systemic reaction is not applicable to this age group
|
NA participants
This systemic reaction is not applicable to this age group
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Sleepiness
|
29 participants
|
13 participants
|
NA participants
This systemic reaction is not applicable to this age group
|
NA participants
This systemic reaction is not applicable to this age group
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Irritability
|
36 participants
|
18 participants
|
NA participants
This systemic reaction is not applicable to this age group
|
NA participants
This systemic reaction is not applicable to this age group
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Vomiting
|
21 participants
|
9 participants
|
NA participants
This systemic reaction is not applicable to this age group
|
NA participants
This systemic reaction is not applicable to this age group
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Diarrhea
|
31 participants
|
20 participants
|
NA participants
This systemic reaction is not applicable to this age group
|
NA participants
This systemic reaction is not applicable to this age group
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Arthralgia
|
26 participants
|
11 participants
|
18 participants
|
15 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Headache
|
46 participants
|
22 participants
|
74 participants
|
46 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Chills
|
NA participants
This systemic reaction is not applicable to this age group
|
NA participants
This systemic reaction is not applicable to this age group
|
18 participants
|
17 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Nausea
|
NA participants
This systemic reaction is not applicable to this age group
|
NA participants
This systemic reaction is not applicable to this age group
|
16 participants
|
11 participants
|
|
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Malaise
|
NA participants
This systemic reaction is not applicable to this age group
|
NA participants
This systemic reaction is not applicable to this age group
|
50 participants
|
28 participants
|
Adverse Events
MenACWY-CRM
Serious events: 9 serious events
Other events: 409 other events
Deaths: 0 deaths
MenACWY-PS
Serious events: 1 serious events
Other events: 271 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenACWY-CRM
n=950 participants at risk
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS
n=550 participants at risk
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
|---|---|---|
|
Nervous system disorders
Tonic Convulsion
|
0.11%
1/950 • Number of events 1 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
0.00%
0/550 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
|
Infections and infestations
Appendicitis
|
0.21%
2/950 • Number of events 2 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
0.00%
0/550 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/950 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
0.18%
1/550 • Number of events 1 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
|
Infections and infestations
Pneumonia
|
0.32%
3/950 • Number of events 3 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
0.00%
0/550 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
|
Injury, poisoning and procedural complications
Injury
|
0.11%
1/950 • Number of events 1 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
0.00%
0/550 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
|
Nervous system disorders
Febrile Convulsion
|
0.11%
1/950 • Number of events 1 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
0.00%
0/550 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic Crisis
|
0.11%
1/950 • Number of events 1 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
0.00%
0/550 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
Other adverse events
| Measure |
MenACWY-CRM
n=950 participants at risk
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
MenACWY-PS
n=550 participants at risk
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
|
|---|---|---|
|
General disorders
Injection site pain
|
23.3%
221/950 • Number of events 221 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
30.5%
168/550 • Number of events 168 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
|
General disorders
Injection site erythema
|
17.5%
166/950 • Number of events 166 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
12.9%
71/550 • Number of events 71 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
|
Nervous system disorders
Headache
|
13.2%
125/950 • Number of events 125 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
13.1%
72/550 • Number of events 72 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
|
General disorders
Injection site induration
|
15.1%
143/950 • Number of events 143 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
11.1%
61/550 • Number of events 61 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
|
General disorders
Pyrexia
|
7.9%
75/950 • Number of events 75 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
8.9%
49/550 • Number of events 49 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
|
General disorders
Malaise
|
5.3%
50/950 • Number of events 50 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
5.1%
28/550 • Number of events 28 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60