Trial Outcomes & Findings for Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months (NCT NCT00601731)
NCT ID: NCT00601731
Last Updated: 2014-10-24
Results Overview
Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
382 participants
Primary outcome timeframe
At 40 and 60 months of age
Results posted on
2014-10-24
Participant Flow
Participants were enrolled at 3 sites (1 site in the UK and 2 sites in Canada).
Participant milestones
| Measure |
UK Site
UK vaccine group that received primary vaccine schedule of MenACWY (adjuvanted and unadjuvanted) vaccine at 2, 3 and 4 months with booster at 12 months of age, enrolled at either 40 or 60 months of age into the current study as follow-on participants.
|
UK Control
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
|
Canada Sites
Canadian vaccine group that received primary vaccination with MenACWY (adjuvanted and unadjuvanted) vaccine at 2,4 months of age with 12 month booster or at 2, 4, 6 months with or without a booster vaccination.
|
Canada Control
Newly enrolled age-matched subjects that received the complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
143
|
43
|
166
|
30
|
|
Overall Study
COMPLETED
|
120
|
43
|
151
|
29
|
|
Overall Study
NOT COMPLETED
|
23
|
0
|
15
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months
Baseline characteristics by cohort
| Measure |
UK2,3,4,12+
n=40 Participants
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4,12+
n=44 Participants
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4C/12+
n=22 Participants
UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4,12-
n=37 Participants
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
|
UK Control
n=43 Participants
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
|
Ca2,4,6+
n=31 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
|
Ca2,4,6+/12PS
n=26 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age
|
Ca2,4,12+
n=27 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
Ca2,4+/12PS
n=28 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age.
|
Ca2,4,12-
n=27 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
|
Ca2,4-/12PS
n=27 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age.
|
Ca Control
n=30 Participants
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
|
Total
n=382 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
40 months (N=36,37,19,34,0,28,23,27,28,25,26,0)
|
42.4 months
STANDARD_DEVIATION 0.7 • n=5 Participants
|
42.6 months
STANDARD_DEVIATION 0.6 • n=7 Participants
|
42.6 months
STANDARD_DEVIATION 0.5 • n=5 Participants
|
40.6 months
STANDARD_DEVIATION 0.8 • n=4 Participants
|
NA months
STANDARD_DEVIATION NA • n=21 Participants
|
42 months
STANDARD_DEVIATION 1 • n=10 Participants
|
41.8 months
STANDARD_DEVIATION 1.2 • n=115 Participants
|
42 months
STANDARD_DEVIATION 0.9 • n=24 Participants
|
41.6 months
STANDARD_DEVIATION 1 • n=42 Participants
|
40.7 months
STANDARD_DEVIATION 1 • n=42 Participants
|
41.0 months
STANDARD_DEVIATION 1.1 • n=42 Participants
|
NA months
STANDARD_DEVIATION NA • n=42 Participants
|
34.78 months
STANDARD_DEVIATION 0.31 • n=36 Participants
|
|
Age, Customized
60 months (N=4,7,3,3,43,3,3,0,0,2,1,30)
|
61.3 months
STANDARD_DEVIATION 1.0 • n=5 Participants
|
61.3 months
STANDARD_DEVIATION 0.5 • n=7 Participants
|
61.0 months
STANDARD_DEVIATION 1.0 • n=5 Participants
|
61.7 months
STANDARD_DEVIATION 0.6 • n=4 Participants
|
61.9 months
STANDARD_DEVIATION 0.3 • n=21 Participants
|
60.3 months
STANDARD_DEVIATION 0.6 • n=10 Participants
|
61.3 months
STANDARD_DEVIATION 0.6 • n=115 Participants
|
NA months
STANDARD_DEVIATION NA • n=24 Participants
|
NA months
STANDARD_DEVIATION NA • n=42 Participants
|
60.5 months
STANDARD_DEVIATION 0.7 • n=42 Participants
|
60.0 months
STANDARD_DEVIATION 0.0 • n=42 Participants
|
60.6 months
STANDARD_DEVIATION 0.6 • n=42 Participants
|
60.88 months
STANDARD_DEVIATION 0.16 • n=36 Participants
|
|
Sex/Gender, Customized
Female 40 months
|
14 Number of subjects
n=5 Participants
|
19 Number of subjects
n=7 Participants
|
14 Number of subjects
n=5 Participants
|
19 Number of subjects
n=4 Participants
|
NA Number of subjects
n=21 Participants
|
19 Number of subjects
n=10 Participants
|
9 Number of subjects
n=115 Participants
|
15 Number of subjects
n=24 Participants
|
10 Number of subjects
n=42 Participants
|
12 Number of subjects
n=42 Participants
|
14 Number of subjects
n=42 Participants
|
NA Number of subjects
n=42 Participants
|
145 Number of subjects
n=36 Participants
|
|
Sex/Gender, Customized
Male 40 months
|
22 Number of subjects
n=5 Participants
|
18 Number of subjects
n=7 Participants
|
5 Number of subjects
n=5 Participants
|
15 Number of subjects
n=4 Participants
|
NA Number of subjects
n=21 Participants
|
9 Number of subjects
n=10 Participants
|
14 Number of subjects
n=115 Participants
|
12 Number of subjects
n=24 Participants
|
18 Number of subjects
n=42 Participants
|
13 Number of subjects
n=42 Participants
|
12 Number of subjects
n=42 Participants
|
NA Number of subjects
n=42 Participants
|
138 Number of subjects
n=36 Participants
|
|
Sex/Gender, Customized
Female 60 months
|
1 Number of subjects
n=5 Participants
|
4 Number of subjects
n=7 Participants
|
1 Number of subjects
n=5 Participants
|
2 Number of subjects
n=4 Participants
|
20 Number of subjects
n=21 Participants
|
2 Number of subjects
n=10 Participants
|
3 Number of subjects
n=115 Participants
|
NA Number of subjects
n=24 Participants
|
NA Number of subjects
n=42 Participants
|
1 Number of subjects
n=42 Participants
|
0 Number of subjects
n=42 Participants
|
15 Number of subjects
n=42 Participants
|
49 Number of subjects
n=36 Participants
|
|
Sex/Gender, Customized
Male 60 months
|
3 Number of subjects
n=5 Participants
|
3 Number of subjects
n=7 Participants
|
2 Number of subjects
n=5 Participants
|
1 Number of subjects
n=4 Participants
|
23 Number of subjects
n=21 Participants
|
1 Number of subjects
n=10 Participants
|
0 Number of subjects
n=115 Participants
|
NA Number of subjects
n=24 Participants
|
NA Number of subjects
n=42 Participants
|
1 Number of subjects
n=42 Participants
|
1 Number of subjects
n=42 Participants
|
15 Number of subjects
n=42 Participants
|
50 Number of subjects
n=36 Participants
|
PRIMARY outcome
Timeframe: At 40 and 60 months of agePopulation: Immunogenicity was evaluated in the Modified Intent To Treat (MITT) population that included subjects who provided at least one evaluable blood sample. Thus, the difference in the number of subjects entered here versus the number of subjects in the participant flow and baseline characteristics (i.e., enrolled subjects) module.
Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
Outcome measures
| Measure |
UK2,3,4,12+
n=33 Participants
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4,12+
n=37 Participants
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4C/12+
n=18 Participants
UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4,12-
n=34 Participants
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
|
UK Control
n=42 Participants
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
|
Ca2,4,6+
n=28 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
|
Ca2,4,6+/12PS
n=25 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age
|
Ca2,4,12+
n=27 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
Ca2,4+/12PS
n=28 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age.
|
Ca2,4,12-
n=25 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
|
Ca2,4-/12PS
n=24 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age.
|
Ca Control
n=30 Participants
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With hSBA ≥1:8
MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29
|
69 Percentages of subjects
Interval 50.0 to 84.0
|
85 Percentages of subjects
Interval 69.0 to 95.0
|
78 Percentages of subjects
Interval 52.0 to 94.0
|
84 Percentages of subjects
Interval 66.0 to 95.0
|
36 Percentages of subjects
Interval 22.0 to 52.0
|
31 Percentages of subjects
Interval 14.0 to 52.0
|
44 Percentages of subjects
Interval 24.0 to 65.0
|
57 Percentages of subjects
Interval 34.0 to 77.0
|
42 Percentages of subjects
Interval 22.0 to 63.0
|
81 Percentages of subjects
Interval 58.0 to 95.0
|
67 Percentages of subjects
Interval 45.0 to 84.0
|
34 Percentages of subjects
Interval 18.0 to 54.0
|
|
Percentage of Subjects With hSBA ≥1:8
MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
|
27 Percentages of subjects
Interval 13.0 to 46.0
|
8 Percentages of subjects
Interval 2.0 to 22.0
|
29 Percentages of subjects
Interval 10.0 to 56.0
|
3 Percentages of subjects
Interval 0.074 to 15.0
|
NA Percentages of subjects
zero participants analyzed
|
0 Percentages of subjects
Interval 0.0 to 12.0
|
4 Percentages of subjects
Interval 0.0 to 22.0
|
7 Percentages of subjects
Interval 1.0 to 24.0
|
0 Percentages of subjects
Interval 0.0 to 12.0
|
8 Percentages of subjects
Interval 1.0 to 26.0
|
0 Percentages of subjects
Interval 0.0 to 14.0
|
NA Percentages of subjects
zero participants analyzed
|
|
Percentage of Subjects With hSBA ≥1:8
MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30
|
9 Percentages of subjects
Interval 2.0 to 24.0
|
11 Percentages of subjects
Interval 3.0 to 27.0
|
11 Percentages of subjects
Interval 1.0 to 35.0
|
3 Percentages of subjects
Interval 0.082 to 17.0
|
0 Percentages of subjects
Interval 0.0 to 8.0
|
0 Percentages of subjects
Interval 0.0 to 13.0
|
0 Percentages of subjects
Interval 0.0 to 14.0
|
4 Percentages of subjects
Interval 0.0 to 22.0
|
4 Percentages of subjects
Interval 0.0 to 20.0
|
4 Percentages of subjects
Interval 0.0 to 22.0
|
0 Percentages of subjects
Interval 0.0 to 14.0
|
3 Percentages of subjects
Interval 0.084 to 17.0
|
|
Percentage of Subjects With hSBA ≥1:8
MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0
|
41 Percentages of subjects
Interval 24.0 to 59.0
|
47 Percentages of subjects
Interval 30.0 to 65.0
|
71 Percentages of subjects
Interval 44.0 to 90.0
|
33 Percentages of subjects
Interval 18.0 to 52.0
|
NA Percentages of subjects
zero participants analyzed
|
20 Percentages of subjects
Interval 6.0 to 44.0
|
14 Percentages of subjects
Interval 3.0 to 35.0
|
31 Percentages of subjects
Interval 14.0 to 52.0
|
35 Percentages of subjects
Interval 17.0 to 56.0
|
38 Percentages of subjects
Interval 19.0 to 59.0
|
46 Percentages of subjects
Interval 26.0 to 67.0
|
NA Percentages of subjects
zero participants analyzed
|
|
Percentage of Subjects With hSBA ≥1:8
MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30
|
34 Percentages of subjects
Interval 19.0 to 53.0
|
32 Percentages of subjects
Interval 17.0 to 51.0
|
59 Percentages of subjects
Interval 33.0 to 82.0
|
45 Percentages of subjects
Interval 27.0 to 64.0
|
29 Percentages of subjects
Interval 16.0 to 45.0
|
14 Percentages of subjects
Interval 3.0 to 36.0
|
13 Percentages of subjects
Interval 3.0 to 32.0
|
14 Percentages of subjects
Interval 3.0 to 35.0
|
24 Percentages of subjects
Interval 8.0 to 47.0
|
27 Percentages of subjects
Interval 11.0 to 50.0
|
46 Percentages of subjects
Interval 26.0 to 67.0
|
53 Percentages of subjects
Interval 34.0 to 72.0
|
|
Percentage of Subjects With hSBA ≥1:8
MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0
|
73 Percentages of subjects
Interval 54.0 to 87.0
|
69 Percentages of subjects
Interval 52.0 to 84.0
|
71 Percentages of subjects
Interval 44.0 to 90.0
|
74 Percentages of subjects
Interval 56.0 to 87.0
|
NA Percentages of subjects
zero participants analyzed
|
29 Percentages of subjects
Interval 13.0 to 49.0
|
48 Percentages of subjects
Interval 27.0 to 69.0
|
59 Percentages of subjects
Interval 39.0 to 78.0
|
43 Percentages of subjects
Interval 24.0 to 63.0
|
72 Percentages of subjects
Interval 51.0 to 88.0
|
58 Percentages of subjects
Interval 37.0 to 78.0
|
NA Percentages of subjects
zero participants analyzed
|
|
Percentage of Subjects With hSBA ≥1:8
MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0
|
76 Percentages of subjects
Interval 58.0 to 89.0
|
61 Percentages of subjects
Interval 43.0 to 77.0
|
76 Percentages of subjects
Interval 50.0 to 93.0
|
53 Percentages of subjects
Interval 35.0 to 70.0
|
NA Percentages of subjects
zero participants analyzed
|
32 Percentages of subjects
Interval 16.0 to 52.0
|
26 Percentages of subjects
Interval 10.0 to 48.0
|
44 Percentages of subjects
Interval 25.0 to 65.0
|
21 Percentages of subjects
Interval 8.0 to 41.0
|
64 Percentages of subjects
Interval 43.0 to 82.0
|
63 Percentages of subjects
Interval 41.0 to 81.0
|
NA Percentages of subjects
zero participants analyzed
|
|
Percentage of Subjects With hSBA ≥1:8
MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30
|
61 Percentages of subjects
Interval 42.0 to 77.0
|
71 Percentages of subjects
Interval 53.0 to 85.0
|
71 Percentages of subjects
Interval 44.0 to 90.0
|
42 Percentages of subjects
Interval 25.0 to 61.0
|
29 Percentages of subjects
Interval 16.0 to 45.0
|
30 Percentages of subjects
Interval 14.0 to 50.0
|
24 Percentages of subjects
Interval 9.0 to 45.0
|
43 Percentages of subjects
Interval 23.0 to 66.0
|
22 Percentages of subjects
Interval 7.0 to 44.0
|
57 Percentages of subjects
Interval 34.0 to 78.0
|
57 Percentages of subjects
Interval 34.0 to 77.0
|
10 Percentages of subjects
Interval 2.0 to 27.0
|
SECONDARY outcome
Timeframe: At 40 and 60 months of agePopulation: The analysis was done on MITT population
Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
Outcome measures
| Measure |
UK2,3,4,12+
n=33 Participants
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4,12+
n=37 Participants
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4C/12+
n=18 Participants
UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4,12-
n=34 Participants
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
|
UK Control
n=42 Participants
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
|
Ca2,4,6+
n=28 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
|
Ca2,4,6+/12PS
n=25 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age
|
Ca2,4,12+
n=27 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
Ca2,4+/12PS
n=28 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age.
|
Ca2,4,12-
n=25 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
|
Ca2,4-/12PS
n=24 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age.
|
Ca Control
n=30 Participants
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With hSBA ≥1:4
MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0
|
47 Percentages of subjects
Interval 29.0 to 65.0
|
53 Percentages of subjects
Interval 35.0 to 70.0
|
71 Percentages of subjects
Interval 44.0 to 90.0
|
42 Percentages of subjects
Interval 25.0 to 61.0
|
NA Percentages of subjects
Zero participants analyzed
|
20 Percentages of subjects
Interval 6.0 to 44.0
|
14 Percentages of subjects
Interval 3.0 to 35.0
|
38 Percentages of subjects
Interval 20.0 to 59.0
|
54 Percentages of subjects
Interval 33.0 to 73.0
|
54 Percentages of subjects
Interval 33.0 to 74.0
|
54 Percentages of subjects
Interval 33.0 to 74.0
|
NA Percentages of subjects
Zero participants analyzed
|
|
Percentage of Subjects With hSBA ≥1:4
MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30
|
50 Percentages of subjects
Interval 32.0 to 68.0
|
44 Percentages of subjects
Interval 27.0 to 62.0
|
71 Percentages of subjects
Interval 44.0 to 90.0
|
52 Percentages of subjects
Interval 33.0 to 70.0
|
40 Percentages of subjects
Interval 26.0 to 57.0
|
24 Percentages of subjects
Interval 8.0 to 47.0
|
29 Percentages of subjects
Interval 13.0 to 51.0
|
32 Percentages of subjects
Interval 14.0 to 55.0
|
48 Percentages of subjects
Interval 26.0 to 70.0
|
59 Percentages of subjects
Interval 36.0 to 79.0
|
58 Percentages of subjects
Interval 37.0 to 78.0
|
67 Percentages of subjects
Interval 47.0 to 83.0
|
|
Percentage of Subjects With hSBA ≥1:4
MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29
|
69 Percentages of subjects
Interval 50.0 to 84.0
|
85 Percentages of subjects
Interval 69.0 to 95.0
|
83 Percentages of subjects
Interval 59.0 to 96.0
|
84 Percentages of subjects
Interval 66.0 to 95.0
|
39 Percentages of subjects
Interval 22.0 to 52.0
|
31 Percentages of subjects
Interval 14.0 to 52.0
|
52 Percentages of subjects
Interval 31.0 to 72.0
|
61 Percentages of subjects
Interval 39.0 to 80.0
|
50 Percentages of subjects
Interval 29.0 to 71.0
|
81 Percentages of subjects
Interval 58.0 to 95.0
|
67 Percentages of subjects
Interval 45.0 to 84.0
|
34 Percentages of subjects
Interval 18.0 to 54.0
|
|
Percentage of Subjects With hSBA ≥1:4
MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
|
30 Percentages of subjects
Interval 16.0 to 49.0
|
8 Percentages of subjects
Interval 2.0 to 22.0
|
29 Percentages of subjects
Interval 10.0 to 56.0
|
3 Percentages of subjects
Interval 0.074 to 15.0
|
NA Percentages of subjects
Zero participants analyzed
|
0 Percentages of subjects
Interval 0.0 to 12.0
|
4 Percentages of subjects
Interval 0.0 to 22.0
|
11 Percentages of subjects
Interval 2.0 to 29.0
|
7 Percentages of subjects
Interval 1.0 to 24.0
|
8 Percentages of subjects
Interval 1.0 to 26.0
|
0 Percentages of subjects
Interval 0.0 to 14.0
|
NA Percentages of subjects
Zero participants analyzed
|
|
Percentage of Subjects With hSBA ≥1:4
MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30
|
15 Percentages of subjects
Interval 5.0 to 32.0
|
11 Percentages of subjects
Interval 3.0 to 27.0
|
22 Percentages of subjects
Interval 6.0 to 48.0
|
3 Percentages of subjects
Interval 0.082 to 17.0
|
0 Percentages of subjects
Interval 0.0 to 8.0
|
4 Percentages of subjects
Interval 0.094 to 19.0
|
0 Percentages of subjects
Interval 0.0 to 14.0
|
9 Percentages of subjects
Interval 1.0 to 28.0
|
4 Percentages of subjects
Interval 0.0 to 20.0
|
9 Percentages of subjects
Interval 1.0 to 28.0
|
0 Percentages of subjects
Interval 0.0 to 14.0
|
7 Percentages of subjects
Interval 1.0 to 22.0
|
|
Percentage of Subjects With hSBA ≥1:4
MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0
|
73 Percentages of subjects
Interval 54.0 to 87.0
|
69 Percentages of subjects
Interval 52.0 to 84.0
|
71 Percentages of subjects
Interval 44.0 to 90.0
|
85 Percentages of subjects
Interval 69.0 to 95.0
|
NA Percentages of subjects
Zero participants analyzed
|
29 Percentages of subjects
Interval 13.0 to 49.0
|
52 Percentages of subjects
Interval 31.0 to 73.0
|
63 Percentages of subjects
Interval 42.0 to 81.0
|
54 Percentages of subjects
Interval 34.0 to 72.0
|
72 Percentages of subjects
Interval 51.0 to 88.0
|
71 Percentages of subjects
Interval 49.0 to 87.0
|
NA Percentages of subjects
Zero participants analyzed
|
|
Percentage of Subjects With hSBA ≥1:4
MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0
|
76 Percentages of subjects
Interval 58.0 to 89.0
|
78 Percentages of subjects
Interval 61.0 to 90.0
|
88 Percentages of subjects
Interval 64.0 to 99.0
|
71 Percentages of subjects
Interval 53.0 to 85.0
|
NA Percentages of subjects
Zero participants analyzed
|
50 Percentages of subjects
Interval 31.0 to 69.0
|
35 Percentages of subjects
Interval 16.0 to 57.0
|
59 Percentages of subjects
Interval 39.0 to 78.0
|
43 Percentages of subjects
Interval 24.0 to 63.0
|
68 Percentages of subjects
Interval 46.0 to 85.0
|
63 Percentages of subjects
Interval 41.0 to 81.0
|
NA Percentages of subjects
Zero participants analyzed
|
|
Percentage of Subjects With hSBA ≥1:4
MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30
|
73 Percentages of subjects
Interval 54.0 to 87.0
|
79 Percentages of subjects
Interval 62.0 to 91.0
|
76 Percentages of subjects
Interval 50.0 to 93.0
|
55 Percentages of subjects
Interval 36.0 to 73.0
|
33 Percentages of subjects
Interval 20.0 to 50.0
|
48 Percentages of subjects
Interval 29.0 to 68.0
|
40 Percentages of subjects
Interval 21.0 to 61.0
|
57 Percentages of subjects
Interval 34.0 to 77.0
|
35 Percentages of subjects
Interval 16.0 to 57.0
|
62 Percentages of subjects
Interval 38.0 to 82.0
|
61 Percentages of subjects
Interval 39.0 to 80.0
|
13 Percentages of subjects
Interval 4.0 to 31.0
|
SECONDARY outcome
Timeframe: At 40 and 60 months of agePopulation: The analysis was done on MITT population
The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.
Outcome measures
| Measure |
UK2,3,4,12+
n=33 Participants
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4,12+
n=37 Participants
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4C/12+
n=18 Participants
UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4,12-
n=34 Participants
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
|
UK Control
n=42 Participants
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
|
Ca2,4,6+
n=28 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
|
Ca2,4,6+/12PS
n=25 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age
|
Ca2,4,12+
n=27 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
Ca2,4+/12PS
n=28 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age.
|
Ca2,4,12-
n=25 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
|
Ca2,4-/12PS
n=24 Participants
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age.
|
Ca Control
n=30 Participants
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
|
3.75 Titers
Interval 2.76 to 5.11
|
2.58 Titers
Interval 1.93 to 3.45
|
4.33 Titers
Interval 2.82 to 6.66
|
2.08 Titers
Interval 1.54 to 2.82
|
NA Titers
Zero participants analyzed
|
2.01 Titers
Interval 1.69 to 2.39
|
2.17 Titers
Interval 1.79 to 2.39
|
2.56 Titers
Interval 2.15 to 3.05
|
2.11 Titers
Interval 1.77 to 2.5
|
2.41 Titers
Interval 2.01 to 2.89
|
2 Titers
Interval 1.66 to 2.4
|
NA Titers
Zero participants analyzed
|
|
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30
|
2.6 Titers
Interval 2.12 to 3.19
|
2.69 Titers
Interval 2.21 to 3.28
|
2.85 Titers
Interval 2.16 to 3.75
|
2.11 Titers
Interval 1.71 to 2.61
|
2 Titers
Interval 1.67 to 2.39
|
2.08 Titers
Interval 1.77 to 2.45
|
2 Titers
Interval 1.69 to 2.36
|
2.37 Titers
Interval 1.99 to 2.82
|
2.2 Titers
Interval 1.86 to 2.6
|
2.36 Titers
Interval 1.98 to 2.8
|
2 Titers
Interval 1.69 to 2.37
|
2.24 Titers
Interval 1.91 to 2.62
|
|
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0
|
6.43 Titers
Interval 3.85 to 11.0
|
7.02 Titers
Interval 4.33 to 11.0
|
23 Titers
Interval 11.0 to 46.0
|
4.29 Titers
Interval 2.59 to 7.11
|
NA Titers
Zero participants analyzed
|
3.18 Titers
Interval 1.98 to 5.1
|
2.68 Titers
Interval 1.71 to 4.2
|
4.17 Titers
Interval 2.77 to 6.27
|
5.45 Titers
Interval 3.62 to 8.2
|
4.98 Titers
Interval 3.26 to 7.62
|
6.45 Titers
Interval 4.22 to 9.86
|
NA Titers
Zero participants analyzed
|
|
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30
|
4.98 Titers
Interval 3.28 to 7.55
|
4.69 Titers
Interval 3.13 to 7.04
|
14 Titers
Interval 8.15 to 26.0
|
6.77 Titers
Interval 4.43 to 10.0
|
3.93 Titers
Interval 2.73 to 5.65
|
2.75 Titers
Interval 1.77 to 4.26
|
2.86 Titers
Interval 1.9 to 4.3
|
3.22 Titers
Interval 2.11 to 4.92
|
4.02 Titers
Interval 2.6 to 6.21
|
4.85 Titers
Interval 3.17 to 7.4
|
6.27 Titers
Interval 4.18 to 9.41
|
9.46 Titers
Interval 6.48 to 14.0
|
|
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
|
23 Titers
Interval 13.0 to 42.0
|
27 Titers
Interval 15.0 to 47.0
|
22 Titers
Interval 9.65 to 50.0
|
26 Titers
Interval 14.0 to 46.0
|
NA Titers
Zero participants analyzed
|
3.86 Titers
Interval 2.15 to 6.93
|
6.77 Titers
Interval 3.55 to 13.0
|
12 Titers
Interval 6.72 to 22.0
|
7.55 Titers
Interval 4.22 to 14.0
|
23 Titers
Interval 13.0 to 43.0
|
16 Titers
Interval 8.63 to 30.0
|
NA Titers
Zero participants analyzed
|
|
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30
|
18 Titers
Interval 10.0 to 32.0
|
35 Titers
Interval 20.0 to 60.0
|
34 Titers
Interval 16.0 to 72.0
|
26 Titers
Interval 15.0 to 45.0
|
6.51 Titers
Interval 3.99 to 11.0
|
3.77 Titers
Interval 2.14 to 6.64
|
7.26 Titers
Interval 4.08 to 13.0
|
10 Titers
Interval 5.77 to 19.0
|
7.02 Titers
Interval 3.9 to 13.0
|
24 Titers
Interval 13.0 to 45.0
|
19 Titers
Interval 11.0 to 35.0
|
5.02 Titers
Interval 2.88 to 8.73
|
|
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
|
22 Titers
Interval 13.0 to 38.0
|
15 Titers
Interval 9.16 to 26.0
|
27 Titers
Interval 13.0 to 58.0
|
9.33 Titers
Interval 5.48 to 16.0
|
NA Titers
Zero participants analyzed
|
5.54 Titers
Interval 3.39 to 9.06
|
4.3 Titers
Interval 2.49 to 7.4
|
7.41 Titers
Interval 4.5 to 12.0
|
3.96 Titers
Interval 2.42 to 6.46
|
13 Titers
Interval 7.47 to 21.0
|
11 Titers
Interval 6.2 to 18.0
|
NA Titers
Zero participants analyzed
|
|
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30
|
11 Titers
Interval 6.87 to 18.0
|
17 Titers
Interval 10.0 to 27.0
|
16 Titers
Interval 8.03 to 32.0
|
7.24 Titers
Interval 4.35 to 12.0
|
4.36 Titers
Interval 2.81 to 6.75
|
5.24 Titers
Interval 3.32 to 8.27
|
4.49 Titers
Interval 2.79 to 7.22
|
6.44 Titers
Interval 3.94 to 11.0
|
3.73 Titers
Interval 2.27 to 6.12
|
11 Titers
Interval 6.57 to 18.0
|
11 Titers
Interval 6.88 to 18.0
|
2.82 Titers
Interval 1.8 to 4.42
|
Adverse Events
Ca2,4,6+
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Ca2,4,6+/12PS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ca2,4,12+
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ca2,4+/12PS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ca2,4,12-
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ca2,4-/12PS
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Ca Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UK2,3,4,12+
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
UK2,4,12+
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
UK2,4C/12+
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
UK2,4,12-
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
UK Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ca2,4,6+
n=28 participants at risk
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
|
Ca2,4,6+/12PS
n=25 participants at risk
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age
|
Ca2,4,12+
n=24 participants at risk
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
Ca2,4+/12PS
n=26 participants at risk
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age.
|
Ca2,4,12-
n=22 participants at risk
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
|
Ca2,4-/12PS
n=25 participants at risk
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age.
|
Ca Control
n=23 participants at risk
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
|
UK2,3,4,12+
n=33 participants at risk
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4,12+
n=33 participants at risk
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4C/12+
n=16 participants at risk
UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4,12-
n=29 participants at risk
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
|
UK Control
n=26 participants at risk
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
3.0%
1/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
3.4%
1/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
|
Infections and infestations
Pneumonia streptococcal
|
3.6%
1/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
3.0%
1/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
3.4%
1/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
4.0%
1/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
|
Psychiatric disorders
Asperger's disorder
|
0.00%
0/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
3.4%
1/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
Other adverse events
| Measure |
Ca2,4,6+
n=28 participants at risk
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
|
Ca2,4,6+/12PS
n=25 participants at risk
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age
|
Ca2,4,12+
n=24 participants at risk
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
Ca2,4+/12PS
n=26 participants at risk
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age.
|
Ca2,4,12-
n=22 participants at risk
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
|
Ca2,4-/12PS
n=25 participants at risk
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age.
|
Ca Control
n=23 participants at risk
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
|
UK2,3,4,12+
n=33 participants at risk
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4,12+
n=33 participants at risk
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4C/12+
n=16 participants at risk
UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
|
UK2,4,12-
n=29 participants at risk
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
|
UK Control
n=26 participants at risk
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Otitis media
|
0.00%
0/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
4.2%
1/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
9.1%
2/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
12.5%
3/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
4.0%
1/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
|
Infections and infestations
H1N1 influenza
|
3.6%
1/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
4.0%
1/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
3.8%
1/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
9.1%
3/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
3.0%
1/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
|
Infections and infestations
Impetigo
|
0.00%
0/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
4.5%
1/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
4.0%
1/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
6.2%
1/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
3.4%
1/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
6.1%
2/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
6.1%
2/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
6.2%
1/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
|
Infections and infestations
Head injury
|
0.00%
0/28 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/24 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/22 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/25 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/23 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/33 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
6.2%
1/16 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
3.4%
1/29 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
0.00%
0/26 • Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60