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Trial record 6 of 19 for:    Vaccine | Meningococcal | Canada

Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00601731
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : September 19, 2012
Last Update Posted : October 24, 2014
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Meningococcal Disease
Interventions Biological: MenACWY-CRM197
Biological: Blood test
Enrollment 382
Recruitment Details Participants were enrolled at 3 sites (1 site in the UK and 2 sites in Canada).
Pre-assignment Details  
Arm/Group Title UK Site UK Control Canada Sites Canada Control
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 143 43 166 30
Completed 120 43 151 29
Not Completed 23 0 15 1
Arm/Group Title UK2,3,4,12+ UK2,4,12+ UK2,4C/12+ UK2,4,12- UK Control Ca2,4,6+ Ca2,4,6+/12PS Ca2,4,12+ Ca2,4+/12PS Ca2,4,12- Ca2,4-/12PS Ca Control Total
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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 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. 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 40 44 22 37 43 31 26 27 28 27 27 30 382
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 40 participants 44 participants 22 participants 37 participants 43 participants 31 participants 26 participants 27 participants 28 participants 27 participants 27 participants 30 participants 382 participants
40 months (N=36,37,19,34,0,28,23,27,28,25,26,0) 42.4  (0.7) 42.6  (0.6) 42.6  (0.5) 40.6  (0.8) NA [1]   (NA) 42  (1) 41.8  (1.2) 42  (0.9) 41.6  (1) 40.7  (1) 41.0  (1.1) NA [1]   (NA) 34.78  (0.31)
60 months (N=4,7,3,3,43,3,3,0,0,2,1,30) 61.3  (1.0) 61.3  (0.5) 61.0  (1.0) 61.7  (0.6) 61.9  (0.3) 60.3  (0.6) 61.3  (0.6) NA [2]   (NA) NA [2]   (NA) 60.5  (0.7) 60.0  (0.0) 60.6  (0.6) 60.88  (0.16)
[1]
Zero participants were in this subgroup.
[2]
Zero participants in this subgroup.
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Number of subjects
Number Analyzed 40 participants 44 participants 22 participants 37 participants 43 participants 31 participants 26 participants 27 participants 28 participants 27 participants 27 participants 30 participants 382 participants
Female 40 months 14 19 14 19 NA [1]  19 9 15 10 12 14 NA [1]  145
Male 40 months 22 18 5 15 NA [1]  9 14 12 18 13 12 NA [1]  138
Female 60 months 1 4 1 2 20 2 3 NA [2]  NA [2]  1 0 15 49
Male 60 months 3 3 2 1 23 1 0 NA [2]  NA [2]  1 1 15 50
[1]
Zero participants were in this subgroup.
[2]
Zero participants in this subgroup.
1.Primary Outcome
Title Percentage of Subjects With hSBA ≥1:8
Hide Description 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.
Time Frame At 40 and 60 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UK2,3,4,12+ UK2,4,12+ UK2,4C/12+ UK2,4,12- UK Control Ca2,4,6+ Ca2,4,6+/12PS Ca2,4,12+ Ca2,4+/12PS Ca2,4,12- Ca2,4-/12PS Ca Control
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 33 37 18 34 42 28 25 27 28 25 24 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
27
(13 to 46)
8
(2 to 22)
29
(10 to 56)
3
(0.074 to 15)
NA [1] 
(NA to NA)
0
(0 to 12)
4
(0 to 22)
7
(1 to 24)
0
(0 to 12)
8
(1 to 26)
0
(0 to 14)
NA [1] 
(NA to NA)
MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30
9
(2 to 24)
11
(3 to 27)
11
(1 to 35)
3
(0.082 to 17)
0
(0 to 8)
0
(0 to 13)
0
(0 to 14)
4
(0 to 22)
4
(0 to 20)
4
(0 to 22)
0
(0 to 14)
3
(0.084 to 17)
MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0
41
(24 to 59)
47
(30 to 65)
71
(44 to 90)
33
(18 to 52)
NA [1] 
(NA to NA)
20
(6 to 44)
14
(3 to 35)
31
(14 to 52)
35
(17 to 56)
38
(19 to 59)
46
(26 to 67)
NA [1] 
(NA to NA)
MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30
34
(19 to 53)
32
(17 to 51)
59
(33 to 82)
45
(27 to 64)
29
(16 to 45)
14
(3 to 36)
13
(3 to 32)
14
(3 to 35)
24
(8 to 47)
27
(11 to 50)
46
(26 to 67)
53
(34 to 72)
MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0
73
(54 to 87)
69
(52 to 84)
71
(44 to 90)
74
(56 to 87)
NA [1] 
(NA to NA)
29
(13 to 49)
48
(27 to 69)
59
(39 to 78)
43
(24 to 63)
72
(51 to 88)
58
(37 to 78)
NA [1] 
(NA to NA)
MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29
69
(50 to 84)
85
(69 to 95)
78
(52 to 94)
84
(66 to 95)
36
(22 to 52)
31
(14 to 52)
44
(24 to 65)
57
(34 to 77)
42
(22 to 63)
81
(58 to 95)
67
(45 to 84)
34
(18 to 54)
MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0
76
(58 to 89)
61
(43 to 77)
76
(50 to 93)
53
(35 to 70)
NA [1] 
(NA to NA)
32
(16 to 52)
26
(10 to 48)
44
(25 to 65)
21
(8 to 41)
64
(43 to 82)
63
(41 to 81)
NA [1] 
(NA to NA)
MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30
61
(42 to 77)
71
(53 to 85)
71
(44 to 90)
42
(25 to 61)
29
(16 to 45)
30
(14 to 50)
24
(9 to 45)
43
(23 to 66)
22
(7 to 44)
57
(34 to 78)
57
(34 to 77)
10
(2 to 27)
[1]
zero participants analyzed
2.Secondary Outcome
Title Percentage of Subjects With hSBA ≥1:4
Hide Description 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.
Time Frame At 40 and 60 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on MITT population
Arm/Group Title UK2,3,4,12+ UK2,4,12+ UK2,4C/12+ UK2,4,12- UK Control Ca2,4,6+ Ca2,4,6+/12PS Ca2,4,12+ Ca2,4+/12PS Ca2,4,12- Ca2,4-/12PS Ca Control
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 33 37 18 34 42 28 25 27 28 25 24 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
30
(16 to 49)
8
(2 to 22)
29
(10 to 56)
3
(0.074 to 15)
NA [1] 
(NA to NA)
0
(0 to 12)
4
(0 to 22)
11
(2 to 29)
7
(1 to 24)
8
(1 to 26)
0
(0 to 14)
NA [1] 
(NA to NA)
MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30
15
(5 to 32)
11
(3 to 27)
22
(6 to 48)
3
(0.082 to 17)
0
(0 to 8)
4
(0.094 to 19)
0
(0 to 14)
9
(1 to 28)
4
(0 to 20)
9
(1 to 28)
0
(0 to 14)
7
(1 to 22)
MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0
47
(29 to 65)
53
(35 to 70)
71
(44 to 90)
42
(25 to 61)
NA [1] 
(NA to NA)
20
(6 to 44)
14
(3 to 35)
38
(20 to 59)
54
(33 to 73)
54
(33 to 74)
54
(33 to 74)
NA [1] 
(NA to NA)
MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30
50
(32 to 68)
44
(27 to 62)
71
(44 to 90)
52
(33 to 70)
40
(26 to 57)
24
(8 to 47)
29
(13 to 51)
32
(14 to 55)
48
(26 to 70)
59
(36 to 79)
58
(37 to 78)
67
(47 to 83)
MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0
73
(54 to 87)
69
(52 to 84)
71
(44 to 90)
85
(69 to 95)
NA [1] 
(NA to NA)
29
(13 to 49)
52
(31 to 73)
63
(42 to 81)
54
(34 to 72)
72
(51 to 88)
71
(49 to 87)
NA [1] 
(NA to NA)
MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29
69
(50 to 84)
85
(69 to 95)
83
(59 to 96)
84
(66 to 95)
39
(22 to 52)
31
(14 to 52)
52
(31 to 72)
61
(39 to 80)
50
(29 to 71)
81
(58 to 95)
67
(45 to 84)
34
(18 to 54)
MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0
76
(58 to 89)
78
(61 to 90)
88
(64 to 99)
71
(53 to 85)
NA [1] 
(NA to NA)
50
(31 to 69)
35
(16 to 57)
59
(39 to 78)
43
(24 to 63)
68
(46 to 85)
63
(41 to 81)
NA [1] 
(NA to NA)
MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30
73
(54 to 87)
79
(62 to 91)
76
(50 to 93)
55
(36 to 73)
33
(20 to 50)
48
(29 to 68)
40
(21 to 61)
57
(34 to 77)
35
(16 to 57)
62
(38 to 82)
61
(39 to 80)
13
(4 to 31)
[1]
Zero participants analyzed
3.Secondary Outcome
Title GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
Hide Description 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.
Time Frame At 40 and 60 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on MITT population
Arm/Group Title UK2,3,4,12+ UK2,4,12+ UK2,4C/12+ UK2,4,12- UK Control Ca2,4,6+ Ca2,4,6+/12PS Ca2,4,12+ Ca2,4+/12PS Ca2,4,12- Ca2,4-/12PS Ca Control
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 33 37 18 34 42 28 25 27 28 25 24 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
3.75
(2.76 to 5.11)
2.58
(1.93 to 3.45)
4.33
(2.82 to 6.66)
2.08
(1.54 to 2.82)
NA [1] 
(NA to NA)
2.01
(1.69 to 2.39)
2.17
(1.79 to 2.39)
2.56
(2.15 to 3.05)
2.11
(1.77 to 2.5)
2.41
(2.01 to 2.89)
2
(1.66 to 2.4)
NA [1] 
(NA to NA)
MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30
2.6
(2.12 to 3.19)
2.69
(2.21 to 3.28)
2.85
(2.16 to 3.75)
2.11
(1.71 to 2.61)
2
(1.67 to 2.39)
2.08
(1.77 to 2.45)
2
(1.69 to 2.36)
2.37
(1.99 to 2.82)
2.2
(1.86 to 2.6)
2.36
(1.98 to 2.8)
2
(1.69 to 2.37)
2.24
(1.91 to 2.62)
MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0
6.43
(3.85 to 11)
7.02
(4.33 to 11)
23
(11 to 46)
4.29
(2.59 to 7.11)
NA [1] 
(NA to NA)
3.18
(1.98 to 5.1)
2.68
(1.71 to 4.2)
4.17
(2.77 to 6.27)
5.45
(3.62 to 8.2)
4.98
(3.26 to 7.62)
6.45
(4.22 to 9.86)
NA [1] 
(NA to NA)
MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30
4.98
(3.28 to 7.55)
4.69
(3.13 to 7.04)
14
(8.15 to 26)
6.77
(4.43 to 10)
3.93
(2.73 to 5.65)
2.75
(1.77 to 4.26)
2.86
(1.9 to 4.3)
3.22
(2.11 to 4.92)
4.02
(2.6 to 6.21)
4.85
(3.17 to 7.4)
6.27
(4.18 to 9.41)
9.46
(6.48 to 14)
MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
23
(13 to 42)
27
(15 to 47)
22
(9.65 to 50)
26
(14 to 46)
NA [1] 
(NA to NA)
3.86
(2.15 to 6.93)
6.77
(3.55 to 13)
12
(6.72 to 22)
7.55
(4.22 to 14)
23
(13 to 43)
16
(8.63 to 30)
NA [1] 
(NA to NA)
MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30
18
(10 to 32)
35
(20 to 60)
34
(16 to 72)
26
(15 to 45)
6.51
(3.99 to 11)
3.77
(2.14 to 6.64)
7.26
(4.08 to 13)
10
(5.77 to 19)
7.02
(3.9 to 13)
24
(13 to 45)
19
(11 to 35)
5.02
(2.88 to 8.73)
MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
22
(13 to 38)
15
(9.16 to 26)
27
(13 to 58)
9.33
(5.48 to 16)
NA [1] 
(NA to NA)
5.54
(3.39 to 9.06)
4.3
(2.49 to 7.4)
7.41
(4.5 to 12)
3.96
(2.42 to 6.46)
13
(7.47 to 21)
11
(6.2 to 18)
NA [1] 
(NA to NA)
MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30
11
(6.87 to 18)
17
(10 to 27)
16
(8.03 to 32)
7.24
(4.35 to 12)
4.36
(2.81 to 6.75)
5.24
(3.32 to 8.27)
4.49
(2.79 to 7.22)
6.44
(3.94 to 11)
3.73
(2.27 to 6.12)
11
(6.57 to 18)
11
(6.88 to 18)
2.82
(1.8 to 4.42)
[1]
Zero participants analyzed
Time Frame Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
Adverse Event Reporting Description 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).
 
Arm/Group Title UK2,3,4,12+ UK2,4,12+ UK2,4C/12+ UK2,4,12- UK Control Ca2,4,6+ Ca2,4,6+/12PS Ca2,4,12+ Ca2,4+/12PS Ca2,4,12- Ca2,4-/12PS Ca Control
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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 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. 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. 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. 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. 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.
All-Cause Mortality
UK2,3,4,12+ UK2,4,12+ UK2,4C/12+ UK2,4,12- UK Control Ca2,4,6+ Ca2,4,6+/12PS Ca2,4,12+ Ca2,4+/12PS Ca2,4,12- Ca2,4-/12PS Ca Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
UK2,3,4,12+ UK2,4,12+ UK2,4C/12+ UK2,4,12- UK Control Ca2,4,6+ Ca2,4,6+/12PS Ca2,4,12+ Ca2,4+/12PS Ca2,4,12- Ca2,4-/12PS Ca Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/33 (3.03%)   1/33 (3.03%)   0/16 (0.00%)   3/29 (10.34%)   0/26 (0.00%)   1/28 (3.57%)   0/25 (0.00%)   0/24 (0.00%)   0/26 (0.00%)   0/22 (0.00%)   1/25 (4.00%)   0/23 (0.00%) 
Infections and infestations                         
Lower respiratory tract infection *  1/33 (3.03%)  0/33 (0.00%)  0/16 (0.00%)  0/29 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/23 (0.00%) 
Pneumonia *  0/33 (0.00%)  0/33 (0.00%)  0/16 (0.00%)  1/29 (3.45%)  0/26 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/23 (0.00%) 
Pneumonia streptococcal *  0/33 (0.00%)  0/33 (0.00%)  0/16 (0.00%)  0/29 (0.00%)  0/26 (0.00%)  1/28 (3.57%)  0/25 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/23 (0.00%) 
Injury, poisoning and procedural complications                         
Accidental overdose *  0/33 (0.00%)  1/33 (3.03%)  0/16 (0.00%)  0/29 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/23 (0.00%) 
Forearm fracture *  0/33 (0.00%)  0/33 (0.00%)  0/16 (0.00%)  1/29 (3.45%)  0/26 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/23 (0.00%) 
Jaw fracture *  0/33 (0.00%)  0/33 (0.00%)  0/16 (0.00%)  0/29 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  1/25 (4.00%)  0/23 (0.00%) 
Psychiatric disorders                         
Asperger's disorder *  0/33 (0.00%)  0/33 (0.00%)  0/16 (0.00%)  1/29 (3.45%)  0/26 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/23 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
UK2,3,4,12+ UK2,4,12+ UK2,4C/12+ UK2,4,12- UK Control Ca2,4,6+ Ca2,4,6+/12PS Ca2,4,12+ Ca2,4+/12PS Ca2,4,12- Ca2,4-/12PS Ca Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/33 (15.15%)   3/33 (9.09%)   3/16 (18.75%)   2/29 (6.90%)   0/26 (0.00%)   1/28 (3.57%)   1/25 (4.00%)   3/24 (12.50%)   1/26 (3.85%)   2/22 (9.09%)   1/25 (4.00%)   0/23 (0.00%) 
Infections and infestations                         
Otitis media *  0/33 (0.00%)  0/33 (0.00%)  0/16 (0.00%)  0/29 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  1/24 (4.17%)  0/26 (0.00%)  2/22 (9.09%)  0/25 (0.00%)  0/23 (0.00%) 
Pneumonia *  0/33 (0.00%)  0/33 (0.00%)  0/16 (0.00%)  0/29 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  3/24 (12.50%)  0/26 (0.00%)  0/22 (0.00%)  1/25 (4.00%)  0/23 (0.00%) 
H1N1 influenza *  3/33 (9.09%)  1/33 (3.03%)  0/16 (0.00%)  0/29 (0.00%)  0/26 (0.00%)  1/28 (3.57%)  1/25 (4.00%)  0/24 (0.00%)  1/26 (3.85%)  0/22 (0.00%)  0/25 (0.00%)  0/23 (0.00%) 
Impetigo *  0/33 (0.00%)  0/33 (0.00%)  1/16 (6.25%)  1/29 (3.45%)  0/26 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  1/22 (4.55%)  1/25 (4.00%)  0/23 (0.00%) 
Lower respiratory tract infection *  2/33 (6.06%)  2/33 (6.06%)  1/16 (6.25%)  0/29 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/23 (0.00%) 
Head injury *  0/33 (0.00%)  0/33 (0.00%)  1/16 (6.25%)  1/29 (3.45%)  0/26 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/23 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
EMail: RegistryContactVaccinesUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00601731    
Other Study ID Numbers: V59P5E1
2007-004978-16
First Submitted: January 15, 2008
First Posted: January 28, 2008
Results First Submitted: October 28, 2011
Results First Posted: September 19, 2012
Last Update Posted: October 24, 2014