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Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers

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ClinicalTrials.gov Identifier: NCT01994629
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : November 4, 2015
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Meningococcal Disease
Interventions Biological: MenACWY-CRM
Biological: MenACWY-TT
Enrollment 202
Recruitment Details Subjects were enrolled from 4 centers in Italy.
Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Hide Arm/Group Description Subjects received one dose of investigational MenACWY-cross reactive material (CRM) vaccine. Subjects received one dose of comparator MenACWY-tetanus toxoid (TT) vaccine.
Period Title: Overall Study
Started 100 102
Completed 99 99
Not Completed 1 3
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             0             3
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old) Total
Hide Arm/Group Description Subjects received one dose of investigational MenACWY-CRM vaccine. Subjects received one dose of comparator MenACWY-TT vaccine. Total of all reporting groups
Overall Number of Baseline Participants 100 102 202
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 100 participants 102 participants 202 participants
12.8  (1) 12.7  (0.9) 12.7  (0.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 102 participants 202 participants
Female
48
  48.0%
46
  45.1%
94
  46.5%
Male
52
  52.0%
56
  54.9%
108
  53.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Subjects
Italy Number Analyzed 100 participants 102 participants 202 participants
100 102 202
1.Primary Outcome
Title Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT.
Hide Description Reactogenicity of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by number of subjects with at least one severe solicited AE within 7 days after vaccination. Solicited AEs included tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever.
Time Frame Day 1 to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the solicited safety data set (all subjects in the exposed set who provided post vaccination reactogenicity data: MenACWY-CRM 99; MenACWY-TT 101).
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Hide Arm/Group Description:
Subjects received one dose of investigational MenACWY-CRM vaccine.
Subjects received one dose of comparator MenACWY-TT vaccine.
Overall Number of Participants Analyzed 99 101
Measure Type: Number
Unit of Measure: Number of Subjects
4 2
2.Secondary Outcome
Title Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Hide Description Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with hSBA titer ≥ 8 directed against Neisseria meningitidis (N. meningitidis) serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by the percentages of subjects with hSBA titer ≥ 8 on Day 180 post-vaccination.
Time Frame Day 1, Day 29 and Day 180 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Full Analysis Set (FAS) Day 29 (subjects who received the vaccine and provided immunogenicity data at Day 29: MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS Day 180 (subjects who received the vaccine and provided immunogenicity data at Day 180: MenACWY-CRM 98; MenACWT-TT 97).
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Hide Arm/Group Description:
Subjects received one dose of investigational MenACWY-CRM vaccine.
Subjects received one dose of comparator MenACWY-TT vaccine.
Overall Number of Participants Analyzed 98 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Subjects
A Day 1 (N=89,92)
2
(0.27 to 7.9)
0
(0 to 3.9)
A Day 29 (N=91,97)
90
(82.1 to 95.4)
88
(79.4 to 93.4)
A Day 180 (N=97,96)
65
(54.6 to 74.4)
30
(21.3 to 40.4)
C Day 1 (N=92,93)
3
(0.7 to 9.2)
1
(0.03 to 5.8)
C Day 29 (N=94,97)
96
(89.5 to 98.8)
86
(77 to 91.9)
C Day 180 (N=96,95)
88
(79.2 to 93.4)
95
(88.1 to 98.3)
W Day 1 (N=81,78)
6
(2 to 13.8)
4
(0.8 to 10.8)
W Day 29 (N=84,87)
62
(50.7 to 72.3)
72
(61.8 to 81.5)
W Day 180 (N=88,89)
88
(78.7 to 93.6)
100
(95.9 to 100)
Y Day 1 (N=84,84)
4
(0.7 to 10.1)
2
(0.29 to 8.3)
Y Day 29 (N=87,91)
41
(30.9 to 52.4)
56
(45.2 to 66.4)
Y Day 180 (N=92,95)
78
(68.4 to 86.2)
98
(92.6 to 99.74)
3.Secondary Outcome
Title Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Hide Description Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with seroresponse defined as for subjects with pre-vaccination hSBA titer < 4, post-vaccination hSBA titer ≥ 8; for subjects with pre-vaccination hSBA titer ≥ 4, an increase of at least four times the pre-vaccination hSBA directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence immune response was measured by the percentage of subjects with seroresponse at Day 180 after vaccination.
Time Frame Day 29 and Day 180 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Hide Arm/Group Description:
Subjects received one dose of investigational MenACWY-CRM vaccine.
Subjects received one dose of comparator MenACWY-TT vaccine.
Overall Number of Participants Analyzed 98 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Subjects
A Day 29 (N=89,92)
88
(79 to 93.7)
87
(78.3 to 93.1)
A Day 180 (N=95,92)
62
(51.6 to 71.9)
29
(20.3 to 39.8)
C Day 29 (N=92,93)
95
(87.8 to 98.2)
84
(74.8 to 90.7)
C Day 180 (N=94,92)
85
(76.3 to 91.6)
93
(86.3 to 97.6)
W Day 29 (N=81,78)
54
(42.9 to 65.4)
73
(61.8 to 82.5)
W Day 180 (N=83,81)
83
(73.3 to 90.5)
99
(93.3 to 99.97)
Y Day 29 (N=84,84)
39
(28.8 to 50.5)
54
(42.4 to 64.5)
Y Day 180 (N=88,87)
74
(63.4 to 82.7)
95
(88.6 to 98.7)
4.Secondary Outcome
Title hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Hide Description Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by hSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by hSBA GMTs at Day 180 after vaccination.
Time Frame Day 1, Day 29 and Day 180 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Hide Arm/Group Description:
Subjects received one dose of investigational MenACWY-CRM vaccine.
Subjects received one dose of comparator MenACWY-TT vaccine.
Overall Number of Participants Analyzed 98 97
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A Day 1 (N=89,92)
2.19
(2.02 to 2.38)
2.04
(1.89 to 2.21)
A Day 29 (N=91,97)
41
(31 to 55)
30
(23 to 40)
A Day 180 (N=97,96)
13
(9.5 to 18)
4.67
(3.43 to 6.36)
C Day 1 (N=92,93)
2.44
(2.16 to 2.76)
2.24
(1.99 to 2.52)
C Day 29 (N=94,97)
30
(23 to 39)
20
(16 to 26)
C Day 180 (N=96,95)
24
(18 to 30)
41
(32 to 53)
W Day 1 (N=81,78)
2.58
(2.12 to 3.15)
2.4
(1.96 to 2.95)
W Day 29 (N=84,87)
9.34
(6.72 to 13)
14
(9.91 to 19)
W Day 180 (N=88,89)
21
(17 to 27)
56
(45 to 70)
Y Day 1 (N=84,84)
2.23
(2.02 to 2.48)
2.16
(1.94 to 2.40)
Y Day 29 (N=87,91)
5.89
(4.27 to 8.13)
8.20
(5.96 to 11)
Y Day 180 (N=92,95)
16
(12 to 21)
26
(20 to 34)
5.Secondary Outcome
Title Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Hide Description Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 8 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 8 on Day 180 after vaccination.
Time Frame Day 1, Day 29 and Day 180 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Hide Arm/Group Description:
Subjects received one dose of investigational MenACWY-CRM vaccine.
Subjects received one dose of comparator MenACWY-TT vaccine.
Overall Number of Participants Analyzed 98 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Subjects
A Day 1 (rabbit; N=63,61)
24
(14 to 36.2)
31
(19.9 to 44.3)
A Day 29 (rabbit; N=73,74)
100
(95.1 to 100)
100
(95.1 to 100)
A Day 180 (rabbit; N=74,75)
100
(95.1 to 100)
93
(85.1 to 97.8)
C Day 1 (rabbit; N=64,62)
3
(0.38 to 10.8)
0
(0 to 5.8)
C Day 29 (rabbit; N=74,74)
92
(83.2 to 97)
97
(90.6 to 99.67)
C Day 180 (rabbit; N=77,76)
64
(51.9 to 74.3)
71
(59.5 to 80.9)
W Day 1 (rabbit; N=61,57)
7
(1.8 to 15.9)
5
(1.1 to 14.6)
W Day 29 (rabbit; N=70,69)
90
(80.5 to 95.9)
91
(82 to 96.7)
W Day 180 (rabbit; N=73,70)
71
(59.4 to 81.2)
87
(77 to 93.9)
Y Day 1 (rabbit; N=61,59)
10
(3.7 to 20.2)
15
(7.2 to 27)
Y Day 29 (rabbit; N=70,70)
90
(80.5 to 95.9)
89
(78.7 to 94.9)
Y Day 180 (rabbit; N=74,71)
80
(68.8 to 88.2)
82
(70.7 to 89.9)
6.Secondary Outcome
Title Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Hide Description Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 128 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 128 on Day 180 after vaccination.
Time Frame Day 1, Day 29 and Day 180 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Hide Arm/Group Description:
Subjects received one dose of investigational MenACWY-CRM vaccine.
Subjects received one dose of comparator MenACWY-TT vaccine.
Overall Number of Participants Analyzed 98 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Subjects
A Day 1 (rabbit; N=63,61)
22
(12.7 to 34.5)
31
(19.9 to 44.3)
A Day 29 (rabbit; N=73,74)
100
(95.1 to 100)
100
(95.1 to 100)
A Day 180 (rabbit; N=74,75)
100
(95.1 to 100)
91
(81.7 to 96.2)
C Day 1 (rabbit; N=64,62)
3
(0.38 to 10.8)
0
(0 to 5.8)
C Day 29 (rabbit; N=74,74)
78
(67.3 to 87.1)
65
(52.9 to 75.6)
C Day 180 (rabbit; N=77,76)
25
(15.6 to 35.8)
33
(22.5 to 44.6)
W Day 1 (rabbit; N=61,57)
7
(1.8 to 15.9)
5
(1.1 to 14.6)
W Day 29 (rabbit; N=70,69)
90
(80.5 to 95.9)
90
(80.2 to 95.8)
W Day 180 (rabbit; N=73,70)
62
(49.5 to 72.8)
66
(53.4 to 76.7)
Y Day 1 (rabbit; N=61,59)
10
(3.7 to 20.2)
12
(4.9 to 22.9)
Y Day 29 (rabbit; N=70,70)
89
(78.7 to 94.9)
86
(75.3 to 92.9)
Y Day 180 (rabbit; N=74,71)
73
(61.4 to 82.6)
62
(49.7 to 73.2)
7.Secondary Outcome
Title Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Hide Description Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with four-fold increase in rSBA titer directed against N. meningitides serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by the percentages of subjects with four-fold increase in rSBA titer on Day 180 after vaccination.
Time Frame Day 29 and Day 180 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Hide Arm/Group Description:
Subjects received one dose of investigational MenACWY-CRM vaccine.
Subjects received one dose of comparator MenACWY-TT vaccine.
Overall Number of Participants Analyzed 98 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Subjects
A Day 29 (rabbit; N=63,61)
100
(94.3 to 100)
93
(84.1 to 98.2)
A Day 180 (rabbit; N=60,61)
97
(88.5 to 99.59)
84
(71.9 to 91.8)
C Day 29 (rabbit; N=64,62)
75
(62.6 to 85)
65
(51.3 to 76.3)
C Day 180 (rabbit; N=64,63)
20
(11.3 to 32.2)
30
(19.2 to 43)
W Day 29 (rabbit; N=61,57)
87
(75.8 to 94.2)
89
(78.5 to 96)
W Day 180 (rabbit; N=58,58)
55
(41.5 to 68.3)
66
(51.9 to 77.5)
Y Day 29 (rabbit; N=61,59)
87
(75.8 to 94.2)
88
(77.1 to 95.1)
Y Day 180 (rabbit; N=61,59)
72
(59.2 to 82.9)
56
(42.4 to 68.8)
8.Secondary Outcome
Title rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Hide Description Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by rSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by rSBA GMTs on Day 180.
Time Frame Day 1, Day 29 and Day 180 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Hide Arm/Group Description:
Subjects received one dose of investigational MenACWY-CRM vaccine.
Subjects received one dose of comparator MenACWY-TT vaccine.
Overall Number of Participants Analyzed 98 97
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A Day 1 (rabbit; N=63,61)
6.62
(3.12 to 14)
12
(5.59 to 26)
A Day 29 (rabbit; N=73,74)
5698
(4226 to 7684)
2827
(2116 to 3775)
A Day 180 (rabbit; N=74,75)
2815
(1741 to 4550)
950
(592 to 1523)
C Day 1 (rabbit; N=64,62)
2.46
(1.98 to 3.05)
2.07
(1.66 to 2.58)
C Day 29 (rabbit; N=74,74)
171
(113 to 259)
142
(95 to 213)
C Day 180 (rabbit; N=77,76)
20
(12 to 33)
22
(13 to 36)
W Day 1 (rabbit; N=61,57)
3.1
(2.09 to 4.59)
3.17
(2.07 to 4.86)
W Day 29 (rabbit; N=70,69)
1092
(570 to 2089)
1060
(553 to 2031)
W Day 180 (rabbit; N=73,70)
91
(46 to 182)
142
(72 to 282)
Y Day 1 (rabbit; N=61,59)
3.46
(2.03 to 5.89)
4.22
(2.42 to 7.38)
Y Day 29 (rabbit; N=70,70)
756
(400 to 1429)
624
(333 to 1168)
Y Day 180 (rabbit; N=74,71)
248
(124 to 495)
140
(70 to 278)
9.Secondary Outcome
Title Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Hide Description Safety was assessed in terms of number of subjects (12 to 15 months old) reporting any and each of solicited local and systemic AEs reported from Day 1 to 7 after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.
Time Frame Day 1 (6 hours) to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on solicited safety data set. MedDRA version v.3.0 was used for the analyses (in the AEs section, MedDRA version v.17.01 was used, leading to a different terminology to describe some of the events reported in this outcome).
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Hide Arm/Group Description:
Subjects received one dose of investigational MenACWY-CRM vaccine.
Subjects received one dose of comparator MenACWY-TT vaccine.
Overall Number of Participants Analyzed 99 101
Measure Type: Number
Unit of Measure: Subjects
Any Local 34 29
Tenderness (N=97,100) 29 26
Erythema (N=97,100) 4 2
Induration (N=97,101) 6 4
Any Systemic 56 57
Irritability (N=96,99) 30 39
Sleepiness (N=96,98) 23 26
Change in eating habits (N=96,100) 22 26
Vomiting (N=96,99) 6 9
Diarrhea (N=96,99) 17 18
Fever (≥ 38.0°C; N=99,100)) 14 13
Prophylatic use of analg./antipyr. (N=97,100) 1 4
Therapeutic use of analg./antipyr. (N=98,100) 13 13
10.Secondary Outcome
Title Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Hide Description Safety was assessed in terms of number of subjects (12 to 15 months old) reporting unsolicited AEs (day 1 to day 29), SAEs, medically attended AEs, AEs leading to premature study withdrawal (Day 1 to Day 180) after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.
Time Frame Day 1 to Day 29 or Day 1 to Day 180 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on unsolicited safety data set ie, all subjects in the exposed set who had post-vaccination unsolicited adverse event records.
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Hide Arm/Group Description:
Subjects received one dose of investigational MenACWY-CRM vaccine.
Subjects received one dose of comparator MenACWY-TT vaccine.
Overall Number of Participants Analyzed 99 101
Measure Type: Number
Unit of Measure: Subjects
Any unsolicited AEs 73 71
AEs leading to premature withdrawal 0 0
SAEs 8 3
Medically attended AEs 73 68
Death 0 0
Time Frame Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Hide Arm/Group Description Subjects received one dose of investigational MenACWY-CRM vaccine. Subjects received one dose of comparator MenACWY-TT vaccine.
All-Cause Mortality
MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/99 (8.08%)      3/101 (2.97%)    
Infections and infestations     
Bacteremia * 1  1/99 (1.01%)  1 0/101 (0.00%)  0
Gastroenteritis rotavirus * 1  0/99 (0.00%)  0 1/101 (0.99%)  1
Cellulitis * 1  1/99 (1.01%)  1 0/101 (0.00%)  0
Rotavirus infection * 1  2/99 (2.02%)  2 0/101 (0.00%)  0
Injury, poisoning and procedural complications     
Head injury * 1  1/99 (1.01%)  1 0/101 (0.00%)  0
Tongue injury * 1  1/99 (1.01%)  1 0/101 (0.00%)  0
Nervous system disorders     
Febrile convulsion * 1  1/99 (1.01%)  1 1/101 (0.99%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 1  0/99 (0.00%)  0 1/101 (0.99%)  1
Skin and subcutaneous tissue disorders     
Urticaria * 1  1/99 (1.01%)  1 0/101 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MenACWY-CRM (12 to 15 Months Old) MenACWY-TT (12 to 15 Months Old)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   83/99 (83.84%)      87/101 (86.14%)    
Gastrointestinal disorders     
Vomiting * 1  8/99 (8.08%)  10 11/101 (10.89%)  13
Diarrhea * 1  21/99 (21.21%)  26 22/101 (21.78%)  29
General disorders     
Injection site induration * 1  25/99 (25.25%)  26 26/101 (25.74%)  26
Injection site pain * 1  29/99 (29.29%)  30 27/101 (26.73%)  27
Pyrexia * 1  31/99 (31.31%)  44 34/101 (33.66%)  48
Injection site erythema * 1  26/99 (26.26%)  26 27/101 (26.73%)  27
Infections and infestations     
Conjunctivitis * 1  6/99 (6.06%)  7 8/101 (7.92%)  9
Ear infection * 1  15/99 (15.15%)  20 4/101 (3.96%)  4
Rhinitis * 1  5/99 (5.05%)  5 2/101 (1.98%)  2
Exhantema subitum * 1  7/99 (7.07%)  7 5/101 (4.95%)  5
Gastroenteritis * 1  2/99 (2.02%)  2 6/101 (5.94%)  6
Nervous system disorders     
Somnolence * 1  23/99 (23.23%)  26 27/101 (26.73%)  30
Psychiatric disorders     
Eating disorder * 1  22/99 (22.22%)  27 26/101 (25.74%)  28
Irritability * 1  30/99 (30.30%)  37 40/101 (39.60%)  46
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 1  1/99 (1.01%)  1 8/101 (7.92%)  12
Upper respiratory tract inflammation * 1  9/99 (9.09%)  10 4/101 (3.96%)  4
Cough * 1  9/99 (9.09%)  11 8/101 (7.92%)  8
Skin and subcutaneous tissue disorders     
Rash * 1  5/99 (5.05%)  5 1/101 (0.99%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.1)
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: NCT01994629    
Other Study ID Numbers: V59_67
2013-000862-13 ( EudraCT Number )
First Submitted: November 11, 2013
First Posted: November 26, 2013
Results First Submitted: August 5, 2015
Results First Posted: November 4, 2015
Last Update Posted: November 4, 2015