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Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan

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: NCT01410474
Recruitment Status : Completed
First Posted : August 5, 2011
Results First Posted : September 22, 2014
Last Update Posted : September 22, 2014
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Bacterial Meningitis
Intervention Biological: Meningococcal ACWY conjugate vaccine
Enrollment 341
Recruitment Details Subjects were enrolled at three study centres in Taiwan.
Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title 2-10 Years 11-18 Years
Hide Arm/Group Description Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Period Title: Overall Study
Started 173 168
Completed 173 167
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title 2-10 Years 11-18 Years Total
Hide Arm/Group Description Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. Total of all reporting groups
Overall Number of Baseline Participants 173 168 341
Hide Baseline Analysis Population Description
Analysis was done on all the enrolled subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 173 participants 168 participants 341 participants
6.3  (2.6) 14.0  (2.2) 10.1  (4.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants 168 participants 341 participants
Female
92
  53.2%
88
  52.4%
180
  52.8%
Male
81
  46.8%
80
  47.6%
161
  47.2%
1.Primary Outcome
Title Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Hide Description

Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29).

Seroresponse is defined as:

  1. for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.
  2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Time Frame Day 1 and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on modified intention-to-treat (MITT) population i.e subjects in the exposed population who provided evaluable serum samples whose assay results were available for at least one serogroup on day 1 and/or day 29.
Arm/Group Title Overall (2 to 18 Years)
Hide Arm/Group Description:
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Overall Number of Participants Analyzed 336
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
MenA (N=335)
83
(79 to 87)
MenC (N=333)
93
(90 to 96)
MenW (N=334)
50
(45 to 55)
MenY (N=333)
65
(60 to 70)
2.Secondary Outcome
Title Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group
Hide Description

Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups.

Seroresponse is defined as:

  1. for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.
  2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Time Frame Day 1 and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on MITT population
Arm/Group Title 2-10 Years 11-18 Years
Hide Arm/Group Description:
Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Overall Number of Participants Analyzed 170 166
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
Men A (N=170,165)
77
(70 to 83)
89
(83 to 93)
MenC (N=167,166)
92
(86 to 95)
95
(90 to 97)
MenW (N=168,166)
54
(46 to 62)
46
(38 to 54)
MenY (N=167,166)
61
(53 to 69)
69
(62 to 76)
3.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Hide Description Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.
Time Frame Day 1 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on MITT population
Arm/Group Title 2-10 Years 11-18 Years Overall (2 to 18 Years)
Hide Arm/Group Description:
Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Overall Number of Participants Analyzed 170 166 336
Geometric Mean (95% Confidence Interval)
Unit of Measure: hSBA Titers
MenA at Day 1(N=170,165,335)
2.05
(1.92 to 2.2)
2.2
(2.05 to 2.36)
2.12
(2.02 to 2.24)
MenA at Day 29(N=170,165,335)
32
(24 to 43)
88
(66 to 117)
53
(42 to 65)
MenC at Day 1 (N=167,166,333)
2.66
(2.35 to 3.02)
3.64
(3.21 to 4.12)
3.11
(2.83 to 3.42)
MenC at Day 29 (N=167,166,333)
117
(93 to 147)
273
(218 to 342)
179
(151 to 211)
MenW at Day 1 (N=168,166,334)
7.32
(5.65 to 9.49)
15
(12 to 19)
10
(8.62 to 13)
MenW at Day 29 (N=168,166,334)
49
(40 to 60)
104
(85 to 127)
71
(61 to 82)
MenY at Day 1 (N=167,166,333)
3.21
(2.69 to 3.83)
3.95
(3.31 to 4.71)
3.56
(3.12 to 4.06)
MenY at Day 29 (N=167,166,333)
26
(20 to 33)
56
(43 to 72)
38
(31 to 46)
4.Secondary Outcome
Title Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Hide Description Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.
Time Frame Day 1 and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on MITT population
Arm/Group Title 2-10 Years 11-18 Years Overall (2 to 18 Years)
Hide Arm/Group Description:
Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Overall Number of Participants Analyzed 170 166 336
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
MenA(N=170,165,335)
16
(12 to 21)
40
(30 to 53)
25
(20 to 31)
MenC (N=167,166,333)
44
(35 to 56)
75
(59 to 95)
57
(48 to 69)
MenW (N=168,166,334)
6.66
(5.19 to 8.54)
6.91
(5.39 to 8.85)
6.78
(5.63 to 8.16)
MenY (N=167,166,333)
8.02
(6.09 to 11)
14
(11 to 19)
11
(8.67 to 13)
5.Secondary Outcome
Title Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Hide Description Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall.
Time Frame Day 1 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on MITT population
Arm/Group Title 2-10 Years 11-18 Years Overall (2 to 18 Years)
Hide Arm/Group Description:
Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Overall Number of Participants Analyzed 170 166 336
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
MenA at Day 1 (N=170,165,335)
1
(0 to 4)
4
(2 to 9)
3
(1 to 5)
MenA at Day 29 (N=170,165,335)
77
(70 to 83)
90
(84 to 94)
83
(79 to 87)
MenC at Day 1 (N=167,166,333)
11
(7 to 17)
23
(17 to 31)
17
(13 to 22)
MenC at Day 29 (N=167,166,333)
95
(90 to 98)
98
(95 to 100)
96
(94 to 98)
MenW at Day 1 (N=168,166,334)
47
(39 to 55)
70
(62 to 77)
58
(53 to 64)
MenW at Day 29 (N=168,166,334)
93
(88 to 96)
99
(96 to 100)
96
(93 to 98)
MenY at Day 1 (N=167,166,333)
22
(16 to 29)
26
(19 to 33)
24
(19 to 29)
MenY at Day 29 (N=167,166,333)
78
(71 to 84)
86
(79 to 91)
82
(77 to 86)
6.Secondary Outcome
Title Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Hide Description Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination.
Time Frame From day 1 through day 7 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.
Arm/Group Title 2-5 Years
Hide Arm/Group Description:
Subjects 2-5 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: Subjects
Injection site tenderness 27
Injection site erythema 7
Injection site induration 6
Change in eating habits 2
Sleepiness 3
Irritability 5
Vomiting 7
Diarrhea 2
Rash - Any 4
Rash - Urticarial 1
Fever (≥38°C) 4
7.Secondary Outcome
Title Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Hide Description Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination.
Time Frame From day 1 through day 7 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on safety population.
Arm/Group Title 6-10 Years 11-18 Years Overall (6-18 Years)
Hide Arm/Group Description:
Subjects 6-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
Subjects 6-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
Overall Number of Participants Analyzed 101 167 268
Measure Type: Number
Unit of Measure: Subjects
Injection site pain 37 62 99
Injection site erythema 17 17 34
Injection site induration 14 12 26
Chills 2 6 8
Nausea 10 10 20
Malaise 13 35 48
Myalgia 20 49 69
Arthralgia 3 13 16
Headache 11 29 40
Rash - Any 7 4 11
Rash - Urticarial 3 3 6
Fever (≥38°C) 3 2 5
Time Frame Throughout the study period (from day 1 through day 29)
Adverse Event Reporting Description A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
 
Arm/Group Title 2-10 Years 11-18 Years Overall (2 to 18 Years)
Hide Arm/Group Description Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
All-Cause Mortality
2-10 Years 11-18 Years Overall (2 to 18 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
2-10 Years 11-18 Years Overall (2 to 18 Years)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/173 (0.58%)      0/167 (0.00%)      1/340 (0.29%)    
Infections and infestations       
Pneumonia * 1  1/173 (0.58%)  1 0/167 (0.00%)  0 1/340 (0.29%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2-10 Years 11-18 Years Overall (2 to 18 Years)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   110/173 (63.58%)      98/167 (58.68%)      208/340 (61.18%)    
Gastrointestinal disorders       
Nausea † 1  10/173 (5.78%)  10 10/167 (5.99%)  10 20/340 (5.88%)  20
General disorders       
Injection site erythema † 1  58/173 (33.53%)  58 43/167 (25.75%)  43 101/340 (29.71%)  101
Injection site induration † 1  49/173 (28.32%)  49 36/167 (21.56%)  36 85/340 (25.00%)  85
Injection site pain † 1  64/173 (36.99%)  64 62/167 (37.13%)  62 126/340 (37.06%)  126
Malaise † 1  13/173 (7.51%)  13 35/167 (20.96%)  35 48/340 (14.12%)  48
Infections and infestations       
Nasopharyngitis * 1  10/173 (5.78%)  10 2/167 (1.20%)  2 12/340 (3.53%)  12
Upper respiratory tract infection * 1  16/173 (9.25%)  16 6/167 (3.59%)  6 22/340 (6.47%)  22
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  3/173 (1.73%)  3 13/167 (7.78%)  13 16/340 (4.71%)  16
Myalgia † 1  20/173 (11.56%)  20 49/167 (29.34%)  49 69/340 (20.29%)  69
Nervous system disorders       
Headache † 1  13/173 (7.51%)  13 29/167 (17.37%)  29 42/340 (12.35%)  42
Skin and subcutaneous tissue disorders       
Rash † 1  11/173 (6.36%)  11 4/167 (2.40%)  4 15/340 (4.41%)  15
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01410474    
Other Study ID Numbers: V59_49
First Submitted: August 3, 2011
First Posted: August 5, 2011
Results First Submitted: March 12, 2013
Results First Posted: September 22, 2014
Last Update Posted: September 22, 2014