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Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India

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ClinicalTrials.gov Identifier: NCT01547715
Recruitment Status : Completed
First Posted : March 8, 2012
Results First Posted : December 31, 2014
Last Update Posted : October 9, 2018
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 180
Recruitment Details Subjects were enrolled from 3 study sites.
Pre-assignment Details All the enrolled subjects were included in the trial.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years
Hide Arm/Group Description Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1. Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1. Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.
Period Title: Overall Study
Started 60 60 60
Completed 60 60 60
Not Completed 0 0 0
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Total
Hide Arm/Group Description Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1 Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1 Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1. Total of all reporting groups
Overall Number of Baseline Participants 60 60 60 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  YEARS
Number Analyzed 60 participants 60 participants 60 participants 180 participants
5.77  (2.5) 14.03  (1.931) 32.67  (12.297) 17.49  (13.432)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
FEMALE
33
  55.0%
33
  55.0%
21
  35.0%
87
  48.3%
MALE
27
  45.0%
27
  45.0%
39
  65.0%
93
  51.7%
1.Primary Outcome
Title Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.
Hide Description

The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A. Seroresponse is defined as:

  • For subjects with a pre-vaccination hSBA titer <1:4, a postvaccination hSBA titer≥1:8
  • For subjects with a pre-vaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Time Frame Day 29 (1 month post vaccination)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Full Analysis Set (FAS), ie, all subjects in the exposed population who provided at least one evaluable serum sample whose assay result is available for at least one serogroup.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 59 58 177
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
75
(62 to 85)
76
(63 to 86)
66
(52 to 78)
72
(65 to 79)
2.Primary Outcome
Title Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C
Hide Description The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.
Time Frame Day 29 (1 month post vaccination)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 58 59 58 175
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
84
(73 to 93)
90
(79 to 96)
90
(79 to 96)
88
(82 to 92)
3.Primary Outcome
Title Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.
Hide Description The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.
Time Frame Day 29 (1 month post vaccination)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 59 57 176
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
58
(45 to 71)
51
(37 to 64)
54
(41 to 68)
55
(47 to 62)
4.Primary Outcome
Title Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.
Hide Description The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.
Time Frame Day 29 (1 month post vaccination)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 58 59 57 174
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
69
(55 to 80)
69
(56 to 81)
75
(62 to 86)
71
(64 to 78)
5.Secondary Outcome
Title Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 1.
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 59 60 179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
0
(0 to 6)
2
(0 to 9)
2
(0 to 9)
1
(0 to 4)
6.Secondary Outcome
Title Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 29.
Time Frame Day 29 (ie, 1 month post vaccination)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 60 58 178
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
75
(62 to 85)
77
(64 to 87)
66
(52 to 78)
72
(65 to 79)
7.Secondary Outcome
Title Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 1.
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 58 59 60 177
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
14
(6 to 25)
24
(14 to 37)
25
(15 to 38)
21
(15 to 28)
8.Secondary Outcome
Title Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 29.
Time Frame Day 29 (ie, 1 month post vaccination)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 60 58 178
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
92
(82 to 97)
97
(88 to 100)
97
(88 to 100)
95
(91 to 98)
9.Secondary Outcome
Title Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W at day 1.
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 59 59 178
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
52
(38 to 65)
63
(49 to 75)
59
(46 to 72)
58
(50 to 65)
10.Secondary Outcome
Title Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W.
Time Frame Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 60 58 178
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
95
(86 to 99)
95
(86 to 99)
93
(83 to 98)
94
(90 to 97)
11.Secondary Outcome
Title Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 1.
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 59 59 59 177
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
22
(12 to 35)
53
(39 to 66)
53
(39 to 66)
42
(35 to 50)
12.Secondary Outcome
Title Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 29.
Time Frame Day 29 (ie, 1 month post vaccination)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 59 60 58 177
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
83
(71 to 92)
95
(86 to 99)
93
(83 to 98)
90
(85 to 94)
13.Secondary Outcome
Title hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 1.
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 59 60 179
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
2.08
(1.97 to 2.20)
2.05
(1.95 to 2.16)
2.07
(1.93 to 2.21)
2.07
(2.00 to 2.14)
14.Secondary Outcome
Title hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 29.
Time Frame Day 29 ( ie, 1 month post vaccination)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 60 58 178
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
30
(19 to 47)
50
(30 to 84)
29
(16 to 51)
35
(26 to 47)
15.Secondary Outcome
Title hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 1.
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 58 59 60 177
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
2.88
(2.26 to 3.65)
4.01
(3.00 to 5.35)
4.14
(3.12 to 5.49)
3.63
(3.11 to 4.25)
16.Secondary Outcome
Title hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 29.
Time Frame Day 29 (ie, 1 month post vaccination)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 60 58 178
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
67
(44 to 101)
191
(117 to 310)
287
(191 to 431)
153
(117 to 199)
17.Secondary Outcome
Title hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 1.
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 59 59 178
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
9.27
(6.33 to 14)
14
(9.13 to 20)
12
(7.70 to 17)
11
(9.05 to 14)
18.Secondary Outcome
Title hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 29.
Time Frame Day 29 (ie, 1 month post vaccination)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 60 58 178
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
60
(44 to 81)
75
(54 to 105)
116
(71 to 187)
80
(64 to 100)
19.Secondary Outcome
Title hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 1.
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 59 59 59 177
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
3.59
(2.75 to 4.70)
7.87
(5.48 to 11)
8.69
(5.98 to 13)
6.26
(5.13 to 7.65)
20.Secondary Outcome
Title hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29
Hide Description To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 29.
Time Frame Day 29 (ie, 1 month post vaccination)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 59 60 58 177
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
45
(29 to 69)
105
(72 to 155)
173
(97 to 309)
93
(70 to 123)
21.Secondary Outcome
Title Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination
Hide Description The safety of one dose of MenACWY – CRM was assessed in terms of the number of subjects reporting any solicited local and systemic reactions.
Time Frame From day 1 to Day 7 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the safety analysis set, ie, all subjects in the exposed population who provided any post-baseline safety data.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 60 60 180
Measure Type: Number
Unit of Measure: Participants
INJECTION SITE REACTIONS 5 17 5 27
SYSTEMIC REACTIONS 3 7 9 19
22.Secondary Outcome
Title Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination
Hide Description The safety of one dose of MenACWY – CRM was assessed in terms of the number of subjects reporting solicited local and systemic reactions.
Time Frame From day 1 to Day 7 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the safety analysis set.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 60 60 180
Measure Type: Number
Unit of Measure: Participants
ANALGESIC ANTIPYRETIC 2 5 2 9
Body Temperature >=40C 0 0 0 0
ERYTHEMA (mm) 0 0 0 0
INDURATION (mm) 0 0 0 0
PAIN 4 17 5 26
TENDERNESS 1 0 0 1
ARTHRALGIA 1 1 0 2
BODY TEMPERATURE >=38C 1 1 1 3
CHANGE IN EATING HABITS 0 0 0 0
CHILLS 0 4 2 6
DIARRHEA 0 0 0 0
HEADACHE 2 5 7 14
IRRITABILITY 0 0 0 0
MALAISE 2 2 2 6
MYALGIA 1 0 2 3
NAUSEA 0 1 1 2
RASH 0 0 0 0
SLEEPINESS 0 0 0 0
VOMITING 0 0 0 0
23.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events
Hide Description The safety of one dose of MenACWY –CRM was assessed in terms of the number of subjects reporting unsolicited adverse events. All AEs were recorded from day 1 to day 7; SAE, medically attended AEs and AEs Leading to premature withdrawal were recorded throughout the entire study period.
Time Frame Day 1 through day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the safety analysis dataset.
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description:
Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
Overall Number of Participants Analyzed 60 60 60 180
Measure Type: Number
Unit of Measure: participants
Any Unsolicited AE 9 6 4 19
Any SAE 0 0 1 0
Medically Attended AEs 8 5 4 17
AEs Leading to premature withdrawal 0 0 0 0
Time Frame Day 1 to Day 29 post vaccination.
Adverse Event Reporting Description Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.
 
Arm/Group Title 2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Hide Arm/Group Description Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1. Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1. Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1 Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
All-Cause Mortality
2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%)   1/60 (1.67%)   1/180 (0.56%) 
General disorders         
PYREXIA  1  0/60 (0.00%)  0/60 (0.00%)  1/60 (1.67%)  1/180 (0.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2 - 10 Years 11 - 18 Years 19 - 75 Years Overall (≥2 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/60 (16.67%)   21/60 (35.00%)   10/60 (16.67%)   41/180 (22.78%) 
General disorders         
CHILLS  1  0/60 (0.00%)  4/60 (6.67%)  2/60 (3.33%)  6/180 (3.33%) 
INJECTION SITE PAIN  1  5/60 (8.33%)  17/60 (28.33%)  5/60 (8.33%)  27/180 (15.00%) 
Infections and infestations         
UPPER RESPIRATORY TRACT INFECTION  1  4/60 (6.67%)  1/60 (1.67%)  0/60 (0.00%)  5/180 (2.78%) 
Nervous system disorders         
HEADACHE  1  2/60 (3.33%)  5/60 (8.33%)  7/60 (11.67%)  14/180 (7.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 14.1
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
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics SRL
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01547715     History of Changes
Other Study ID Numbers: V59_43
First Submitted: February 23, 2012
First Posted: March 8, 2012
Results First Submitted: December 18, 2014
Results First Posted: December 31, 2014
Last Update Posted: October 9, 2018