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Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults

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: NCT01272180
Recruitment Status : Completed
First Posted : January 7, 2011
Results First Posted : September 26, 2014
Last Update Posted : September 26, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Invasive Meningococcal Disease
Interventions Biological: Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.
Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
Biological: Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.
Enrollment 484
Recruitment Details  
Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB +OMV ACWY
Hide Arm/Group Description Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart. Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart. Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart. Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
Period Title: Overall Study
Started 120 121 122 121
Completed 103 100 109 107
Not Completed 17 21 13 14
Reason Not Completed
Adverse Event             0             0             1             0
Withdrawal by Subject             2             6             3             2
Lost to Follow-up             15             14             8             10
Inappropriate enrollment             0             0             1             1
Protocol Violation             0             1             0             1
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB +OMV ACWY Total
Hide Arm/Group Description Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart. Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart. Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart. Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later. Total of all reporting groups
Overall Number of Baseline Participants 120 121 122 121 484
Hide Baseline Analysis Population Description
Anaysis was done on the All Enrolled Population, ie, all subjects who signed an informed consent/assent, undergone screening procedure(s) and were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 121 participants 122 participants 121 participants 484 participants
14.7  (4.7) 15.1  (4.9) 15.3  (4.9) 15.0  (5.1) 15.0  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 121 participants 122 participants 121 participants 484 participants
Female
61
  50.8%
68
  56.2%
60
  49.2%
64
  52.9%
253
  52.3%
Male
59
  49.2%
53
  43.8%
62
  50.8%
57
  47.1%
231
  47.7%
1.Primary Outcome
Title Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.
Hide Description

Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y.

Seroresponse is defined as:

  1. For subjects with a pre-vaccination hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8;
  2. For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination titer.

Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA).

Time Frame One month after the second vaccination (Day 91)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per protocol population, immunogenicity, i.e subjects who received correct vaccines in both the visits; provided evaluable serum sample pre and post vaccination with assay results available for at least one serogroup and/or strain and had no major protocol violations.
Arm/Group Title ABCWY+OMV ABCWY+qOMV ACWY
Hide Arm/Group Description:
Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
Overall Number of Participants Analyzed 88 84 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Men A (N=88, 83, 75)
90
(81 to 95)
92
(83 to 97)
73
(62 to 83)
Men C (N=86, 84, 76)
95
(89 to 99)
93
(85 to 97)
63
(51 to 74)
Men W-135 (N=75, 73, 60)
80
(69 to 88)
84
(73 to 91)
65
(52 to 77)
Men Y (N=65, 70, 59)
92
(83 to 97)
90
(80 to 96)
75
(62 to 85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABCWY+OMV, ACWY
Comments Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.
Method of Estimation Estimation Parameter Group Difference % (ABCWY+OMV - ACWY)
Estimated Value 16
Confidence Interval (2-Sided) 95%
5 to 29
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABCWY+OMV, ACWY
Comments Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between MenABCWY and MenACWY groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.
Method of Estimation Estimation Parameter Group Difference % (ABCWY+OMV - ACWY)
Estimated Value 32
Confidence Interval (2-Sided) 95%
21 to 44
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABCWY+OMV, ACWY
Comments Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.
Method of Estimation Estimation Parameter Group Difference % (ABCWY+OMV - ACWY)
Estimated Value 15
Confidence Interval (2-Sided) 95%
0 to 30
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABCWY+OMV, ACWY
Comments Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses MenABCWY combination vaccine to that of one dose of MenACWY vaccine.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.
Method of Estimation Estimation Parameter Group Difference % (ABCWY+OMV - ACWY)
Estimated Value 18
Confidence Interval (2-Sided) 95%
5 to 31
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABCWY+qOMV, ACWY
Comments Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.
Method of Estimation Estimation Parameter Group Difference % (ABCWY+qOMV - ACWY)
Estimated Value 18
Confidence Interval (2-Sided) 95%
7 to 30
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ABCWY+qOMV, ACWY
Comments Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.
Method of Estimation Estimation Parameter Group Difference % (ABCWY+qOMV - ACWY)
Estimated Value 30
Confidence Interval (2-Sided) 95%
18 to 42
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection ABCWY+qOMV, ACWY
Comments Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.
Method of Estimation Estimation Parameter Group Difference % (ABCWY+qOMV - ACWY)
Estimated Value 19
Confidence Interval (2-Sided) 95%
4 to 33
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection ABCWY+qOMV, ACWY
Comments Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days.
Method of Estimation Estimation Parameter Group Difference % (ABCWY+qOMV - ACWY)
Estimated Value 15
Confidence Interval (2-Sided) 95%
3 to 29
Estimation Comments [Not Specified]
2.Primary Outcome
Title Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters.
Hide Description The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation.
Time Frame One month after the second vaccination (Day 91)
Hide Outcome Measure Data
Hide Analysis Population Description

Analysis was done on the Per Protocol Set - desirability, ie, all subjects who :

correctly received the vaccine at Visit 1 and Visit 2, provided evaluable serum samples pre- (Visit 1) and post-vaccination (Visit 3), provided post-vaccination solicited adverse event data an had no major protocol violation as defined prior to unblinding.

Arm/Group Title ABCWY+OMV ABCWY+qOMV
Hide Arm/Group Description:
Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
Overall Number of Participants Analyzed 86 82
Measure Type: Number
Unit of Measure: Desirability index
0.306 0.325
3.Secondary Outcome
Title Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Hide Description Percentages of subjects with hSBA titers ≥ 1:8 against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine or one dose of MenACWY vaccine.
Time Frame Day 1 and one month after second vaccination (Day 91)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per protocol population, immunogenicity.
Arm/Group Title ABCWY+OMV ABCWY+qOMV ACWY
Hide Arm/Group Description:
Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
Overall Number of Participants Analyzed 90 85 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Men A (Day 1)
8
(3 to 15)
6
(2 to 13)
1
(0.033 to 7)
Men A (Day 91; N=88, 83, 75)
93
(86 to 97)
95
(88 to 99)
73
(62 to 83)
Men C (Day 1; N=88, 85, 76)
35
(25 to 46)
35
(25 to 46)
32
(21 to 43)
Men C (Day 91; N=86, 84, 76)
99
(94 to 100)
100
(96 to 100)
83
(73 to 91)
Men W-135 (Day 1; N=86, 79, 68)
66
(55 to 76)
58
(47 to 69)
51
(39 to 64)
Men W-135 (Day 91; N=77, 75, 65)
100
(95 to 100)
100
(95 to 100)
89
(79 to 96)
Men Y (Day 1; N=89, 85, 74)
18
(11 to 28)
15
(8 to 25)
8
(3 to 17)
Men Y (Day 91; N=65, 70, 60)
97
(89 to 100)
97
(90 to 100)
82
(70 to 90)
4.Secondary Outcome
Title The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Hide Description The hSBA GMTs against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine, or one dose of MenACWY vaccine.
Time Frame Day 1 and one month after the second vaccination (Day 91)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per protocol population, immunogenicity.
Arm/Group Title ABCWY+OMV ABCWY+qOMV ACWY
Hide Arm/Group Description:
Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
Overall Number of Participants Analyzed 90 85 76
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Men A (Day 1)
1.57
(1.28 to 1.92)
1.32
(1.07 to 1.63)
1.33
(1.08 to 1.65)
Men A (Day 91; N=88, 83, 75)
71
(49 to 102)
77
(53 to 111)
45
(31 to 65)
Men C (Day 1; N=88, 85, 76)
4.15
(3.02 to 5.69)
3.72
(2.69 to 5.12)
3.93
(2.84 to 5.45)
Men C (Day 91; N=86, 84, 76)
214
(148 to 309)
187
(129 to 272)
55
(38 to 80)
Men W-135 (Day 1; N=86, 79, 68)
14
(8.88 to 22)
10
(6.45 to 16)
6.58
(4.11 to 11)
Men W-135 (Day 91; N=77, 75, 65)
239
(178 to 322)
288
(214 to 389)
65
(48 to 90)
Men Y (Day 1; N=89, 85, 74)
2.01
(1.52 to 2.66)
1.91
(1.43 to 2.53)
1.52
(1.14 to 2.04)
Men Y (Day 91; N=65, 70, 60)
149
(95 to 234)
129
(83 to 201)
46
(29 to 72)
5.Secondary Outcome
Title Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Hide Description The percentages of subjects with hSBA titers ≥ 1:5 and ≥ 1:8 against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.
Time Frame Day 1 and one month after the second vaccination (Day 91)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population, immunogenicity
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB +OMV
Hide Arm/Group Description:
Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
Overall Number of Participants Analyzed 90 85 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
M14459 (Day 1; hSBA ≥1:5)
9
(4 to 17)
4
(1 to 10)
5
(2 to 12)
M14459 (Day 91; hSBA ≥1:5; N=89, 85, 92)
64
(53 to 74)
71
(60 to 80)
82
(72 to 89)
M01-0240364 (Day 1; hSBA ≥1:5; N=90, 84, 91)
3
(1 to 9)
14
(8 to 24)
4
(1 to 11)
M01-0240364 (Day 91; hSBA ≥1:5; N=86, 84, 90)
80
(70 to 88)
80
(70 to 88)
93
(86 to 98)
NZ 98/254 (Day 1; hSBA ≥1:5; N=89, 85, 92)
3
(1 to 10)
1
(0.03 to 6)
3
(1 to 9)
NZ 98/254 (Day 91; hSBA ≥1:5; N=89, 84, 92)
62
(51 to 72)
56
(45 to 67)
88
(80 to 94)
M07-0241084 (Day 1; hSBA ≥1:5; N=89, 84, 92)
26
(17 to 36)
27
(18 to 38)
23
(15 to 33)
M07-0241084 (Day 91; hSBA ≥1:5; N=88, 85, 92)
64
(53 to 74)
55
(44 to 66)
73
(63 to 82)
M14459 (Day 1; hSBA ≥1:8)
6
(2 to 12)
2
(0 to 8)
4
(1 to 11)
M14459 (Day 91; hSBA ≥1:8; N=89, 85, 92)
58
(47 to 69)
66
(55 to 76)
77
(67 to 85)
M01-0240364 (Day 1; hSBA ≥1:8; N=90, 84, 91)
2
(0 to 8)
13
(7 to 22)
4
(1 to 11)
M01-0240364 (Day 91; hSBA ≥1:8; N=86, 84, 90)
79
(69 to 87)
79
(68 to 87)
91
(83 to 96)
NZ 98/254 (Day 1; hSBA ≥ 8; N=89, 85, 92)
3
(1 to 10)
0
(0 to 4)
3
(1 to 9)
NZ 98/254 (Day 91; hSBA ≥1:8; N=89, 84, 92)
47
(37 to 58)
49
(38 to 60)
77
(67 to 85)
M07-0241084 (Day 1; hSBA ≥1:8; N=89, 84, 92)
18
(11 to 28)
20
(12 to 30)
14
(8 to 23)
M07-0241084 (Day 91; hSBA ≥1:8; N=88, 85, 92)
49
(38 to 60)
47
(36 to 58)
60
(49 to 70)
6.Secondary Outcome
Title Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Hide Description

The percentages of subjects with at least 4-fold increase in hSBA titers against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.

4-fold increase is defined as follows;

for subjects with a prevaccination hSBA < 1:2, a postvaccination hSBA ≥ 1:8, for subjects with a prevaccination hSBA ≥ 1:2, at least a 4-fold increase.

Time Frame One month after the second vaccination (Day 91)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population, immunogenicity.
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB+OMV
Hide Arm/Group Description:
Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
Overall Number of Participants Analyzed 89 85 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
M14459
56
(45 to 67)
62
(51 to 73)
75
(65 to 83)
M01-0240364 (N=86, 83, 89)
79
(69 to 87)
70
(59 to 79)
88
(79 to 94)
NZ98/254 (N=88, 84, 92)
47
(36 to 58)
48
(37 to 59)
76
(66 to 84)
M07-0241084 (N=87, 84, 92)
28
(19 to 38)
25
(16 to 36)
42
(32 to 53)
7.Secondary Outcome
Title The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Hide Description The hSBA GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.
Time Frame Day 1 and one month after the second vaccination (Day 91)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population, immunogenicity.
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB +OMV
Hide Arm/Group Description:
Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart.
Overall Number of Participants Analyzed 90 85 92
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
M14459 (Day 1)
1.32
(1.09 to 1.59)
1.15
(0.95 to 1.4)
1.26
(1.04 to 1.53)
M14459 (Day 91; N= 89, 85, 92)
9.24
(6.19 to 14)
11
(7.51 to 17)
17
(11 to 25)
M01-0240364 (Day 1; N=90, 84, 91)
1.08
(0.82 to 1.42)
1.72
(1.29 to 2.28)
1.14
(0.86 to 1.51)
M01-0240364 (Day 91; N= 86, 84, 90)
55
(33 to 93)
48
(28 to 83)
118
(69 to 202)
NZ 98/254 (Day 1; N= 89, 85, 92)
1.2
(1.03 to 1.39)
1.1
(0.94 to 1.28)
1.21
(1.04 to 1.42)
NZ 98/254 (Day 91; N= 89, 84, 92)
8.68
(5.91 to 13)
7.88
(5.3 to 12)
19
(13 to 27)
M07-0241084 (Day 1; N= 89, 84, 92)
2.55
(1.86 to 3.49)
2.45
(1.76 to 3.4)
2.13
(1.54 to 2.94)
M07-0241084 (Day 91; N= 88, 85, 92)
7.24
(5.4 to 9.71)
6.26
(4.63 to 8.46)
12
(8.83 to 16)
8.Secondary Outcome
Title The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Hide Description The geometric mean ratio (GMR) of post vaccination versus pre vaccination GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.
Time Frame One month after the second vaccination/prevaccination (Day 91/day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB+OMV
Hide Arm/Group Description:
Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
Overall Number of Participants Analyzed 89 85 92
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
M14459
7.32
(4.89 to 11)
9.41
(6.19 to 14)
14
(9.01 to 21)
M01-0240364 (N=86, 83, 89)
48
(27 to 83)
30
(17 to 54)
98
(56 to 173)
NZ 98/254 (N=88, 84, 92)
7.44
(5.06 to 11)
6.91
(4.64 to 10)
16
(11 to 23)
M07-0241084 (N=87, 84, 92)
2.94
(2.15 to 4.02)
2.59
(1.88 to 3.58)
5.16
(3.76 to 7.08)
9.Secondary Outcome
Title The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study.
Hide Description The number of subjects reporting solicited local and systemic adverse events and other indicators of reactogenicity after vaccination with ABCWY+OMV, ABCWY+qOMV or rMenB+OMV or MenACWY.
Time Frame Day 1 through day 7 after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the solicited safety set, ie all subjects in the all exposed set who provided postvaccination solicited AE data from day 1 (6 hours) through day 7. The all exposed set is defined as all subjects in the all enrolled population who actually received a study vaccination.
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB+OMV ACWY
Hide Arm/Group Description:
Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
Overall Number of Participants Analyzed 108 110 115 99
Measure Type: Number
Unit of Measure: Participants
Injection site erythema (N=107, 110, 115, 99) 57 53 72 30
Injection site induration (N=107, 110, 115, 99) 46 52 46 24
Injection site pain 98 96 107 50
Chills 18 21 29 12
Nausea 15 25 30 8
Fatigue 32 47 52 30
Myalgia 65 67 67 38
Arthralgia 20 23 25 7
Headache 37 40 53 29
Rash 6 8 4 6
Loss of appetite 17 22 24 12
Fever ( >= 38C ) 7 5 6 1
Medically attended fever 2 0 0 0
Prophylactic use of antipyretic 17 14 16 7
Therapeutic use of antipyretic 18 26 27 10
10.Secondary Outcome
Title The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study.
Hide Description The number of subjects reporting unsolicited AEs after vaccination with ABCWY+OMV, ABCWY+qOMV, rMenB+OMV or MenACWY.
Time Frame Throughout the study ( Day 1 to Day 241)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the unsolicited safety set, ie, all subjects in the all exposed set who provided postvaccination unsolicited AE data.
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB+OMV ACWY
Hide Arm/Group Description:
Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
Overall Number of Participants Analyzed 120 120 120 109
Measure Type: Number
Unit of Measure: Participants
Any AEs (from day 1 to 30) 36 36 45 31
At least possibly related AEs (day 1 to 30) 12 10 16 6
Any AEs (day 31 to 60 or study termination) 22 29 29 26
At least poss.rel.AEs(day 31 to 60 or study term.) 0 1 0 0
Any AE from day 1 to 91 51 55 66 50
At least poss.rel.AEs(day 1 to 91) 13 10 16 6
Medically attended AEs (day 92 to 241) 26 24 30 31
possibly related med.attend.AEs (day 92-241) 0 0 0 0
SAEs (Day 1 to Day 241) 2 2 1 3
Possibly/probably related SAEs 0 0 0 0
AEs leading to withdrawal (Day 1 to Day 241) 0 0 2 0
Deaths (Day 1 to Day 241) 0 0 0 0
Time Frame Solicited AEs were collected from Day 1to Day 7; unsolicited AEs and SAEs were collected throughout the study period (Day 1 to Day 241).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB +OMV ACWY
Hide Arm/Group Description Subjects in this group received two doses of rMenB(+ OMV_full dose) and MenACWY combination vaccine, administered two months apart.

Subjects in this group received two doses of rMenB (+ OMV_1/4th dose)

+and MenACWY combination vaccine, administered two months apart.

Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart. Subjects in this group received first dose of placebo followed by one dose of MenACWY vaccine administered two months apart.
All-Cause Mortality
ABCWY+OMV ABCWY+qOMV rMenB +OMV ACWY
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
ABCWY+OMV ABCWY+qOMV rMenB +OMV ACWY
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/120 (1.67%)   2/120 (1.67%)   1/120 (0.83%)   3/109 (2.75%) 
Gastrointestinal disorders         
ABDOMINAL PAIN * 1  0/120 (0.00%)  0/120 (0.00%)  0/120 (0.00%)  1/109 (0.92%) 
Infections and infestations         
GASTROENTERITIS * 1  1/120 (0.83%)  0/120 (0.00%)  0/120 (0.00%)  0/109 (0.00%) 
PERTUSSIS * 1  0/120 (0.00%)  1/120 (0.83%)  0/120 (0.00%)  0/109 (0.00%) 
PNEUMONIA * 1  1/120 (0.83%)  0/120 (0.00%)  0/120 (0.00%)  0/109 (0.00%) 
URINARY TRACT INFECTION * 1  0/120 (0.00%)  1/120 (0.83%)  0/120 (0.00%)  0/109 (0.00%) 
Nervous system disorders         
CONVULSION * 1  0/120 (0.00%)  0/120 (0.00%)  1/120 (0.83%)  0/109 (0.00%) 
Psychiatric disorders         
ABNORMAL BEHAVIOUR * 1  0/120 (0.00%)  1/120 (0.83%)  0/120 (0.00%)  0/109 (0.00%) 
Reproductive system and breast disorders         
SPERMATOCELE * 1  0/120 (0.00%)  0/120 (0.00%)  0/120 (0.00%)  1/109 (0.92%) 
Respiratory, thoracic and mediastinal disorders         
SLEEP APNOEA SYNDROME * 1  0/120 (0.00%)  0/120 (0.00%)  0/120 (0.00%)  1/109 (0.92%) 
*
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%
ABCWY+OMV ABCWY+qOMV rMenB +OMV ACWY
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   104/120 (86.67%)   104/120 (86.67%)   111/120 (92.50%)   87/109 (79.82%) 
Gastrointestinal disorders         
Diarrhoea * 1  4/120 (3.33%)  2/120 (1.67%)  2/120 (1.67%)  6/109 (5.50%) 
Nausea  1  15/120 (12.50%)  25/120 (20.83%)  31/120 (25.83%)  9/109 (8.26%) 
General disorders         
Chills  1  19/120 (15.83%)  22/120 (18.33%)  29/120 (24.17%)  12/109 (11.01%) 
Fatigue  1  33/120 (27.50%)  47/120 (39.17%)  52/120 (43.33%)  32/109 (29.36%) 
Injection site Erythema  1  59/120 (49.17%)  53/120 (44.17%)  72/120 (60.00%)  32/109 (29.36%) 
Injection site Induration  1  47/120 (39.17%)  52/120 (43.33%)  46/120 (38.33%)  25/109 (22.94%) 
Injection site Pain  1  100/120 (83.33%)  97/120 (80.83%)  107/120 (89.17%)  56/109 (51.38%) 
Pyrexia  1  14/120 (11.67%)  8/120 (6.67%)  7/120 (5.83%)  7/109 (6.42%) 
Infections and infestations         
Nasopharyngitis * 1  3/120 (2.50%)  8/120 (6.67%)  6/120 (5.00%)  5/109 (4.59%) 
Otitis media acute * 1  2/120 (1.67%)  0/120 (0.00%)  2/120 (1.67%)  6/109 (5.50%) 
Pharyngitis * 1  7/120 (5.83%)  8/120 (6.67%)  7/120 (5.83%)  5/109 (4.59%) 
Pharyngitis streptococcal * 1  4/120 (3.33%)  5/120 (4.17%)  1/120 (0.83%)  9/109 (8.26%) 
Upper respiratory tract infection * 1  5/120 (4.17%)  8/120 (6.67%)  11/120 (9.17%)  8/109 (7.34%) 
Metabolism and nutrition disorders         
Decreased appetite  1  17/120 (14.17%)  22/120 (18.33%)  24/120 (20.00%)  12/109 (11.01%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  22/120 (18.33%)  24/120 (20.00%)  25/120 (20.83%)  8/109 (7.34%) 
Myalgia  1  65/120 (54.17%)  67/120 (55.83%)  67/120 (55.83%)  39/109 (35.78%) 
Nervous system disorders         
Headache  1  38/120 (31.67%)  41/120 (34.17%)  53/120 (44.17%)  32/109 (29.36%) 
Respiratory, thoracic and mediastinal disorders         
Rhinitis allergic * 1  5/120 (4.17%)  4/120 (3.33%)  3/120 (2.50%)  7/109 (6.42%) 
Skin and subcutaneous tissue disorders         
Rash  1  6/120 (5.00%)  9/120 (7.50%)  4/120 (3.33%)  6/109 (5.50%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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
EMail: RegistryContactVaccinesUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01272180    
Other Study ID Numbers: V102_03
2010-023523-23 ( EudraCT Number )
First Submitted: January 6, 2011
First Posted: January 7, 2011
Results First Submitted: January 31, 2014
Results First Posted: September 26, 2014
Last Update Posted: September 26, 2014