ClinicalTrials.gov
ClinicalTrials.gov Menu

Novartis Vaccine and Diagnostics Carriage Trial

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: NCT01214850
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : January 23, 2014
Last Update Posted : April 21, 2016
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 N. Meningitidis Carriage
Interventions Biological: Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)
Biological: MenACWY-CRM conjugate vaccine
Biological: Japanese Encephalitis vaccine
Enrollment 2968
Recruitment Details Subjects were enrolled from 10 sites in United Kingdom
Pre-assignment Details Total 2968 subjects were enrolled of which 14 subjects were not randomized and were therefore removed from the study (2 subjects withdrew consent and 11 subjects were withdrawn due to inappropriate enrollment and 1 withdrawn due to protocol violation).
Arm/Group Title rMenB+OMV MenACWY Control
Hide Arm/Group Description Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Period Title: Overall Study
Started 979 988 987
Completed 796 844 826
Not Completed 183 144 161
Reason Not Completed
Withdrawal by Subject             38             31             28
Lost to Follow-up             124             98             123
Protocol Violation             5             5             6
Adverse event or death             11             8             3
Inappropriate enrollment             2             1             0
Administrative reason             1             0             0
Unable to classify             2             1             1
Arm/Group Title rMenB+OMV MenACWY Control Total
Hide Arm/Group Description Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart Total of all reporting groups
Overall Number of Baseline Participants 979 988 987 2954
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 979 participants 988 participants 987 participants 2954 participants
19.9  (1.6) 19.9  (1.6) 19.8  (1.6) 19.9  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 979 participants 988 participants 987 participants 2954 participants
Female
516
  52.7%
533
  53.9%
547
  55.4%
1596
  54.0%
Male
463
  47.3%
455
  46.1%
440
  44.6%
1358
  46.0%
1.Primary Outcome
Title Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination
Hide Description

Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported.

Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010.

Time Frame 61 days (31 days after receiving the second injection)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the modified-intention to treat (MITT) dataset (Pharyngeal carriage), i.e subjects who actually received a study vaccination and provided at least one evaluable swab sample at baseline and after vaccination.
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 974 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
8
(6 to 10)
7
(6 to 9)
Month 2 (N= 916, 928)
9
(8 to 12)
8
(6 to 10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rMenB+OMV, Control
Comments Vaccine Group Odds Ratios for carriage of virulent ST strain of N. meningitidis group B in 4CMenB group as compared to the control group at 1 month after receiving the 2nd rMenB+OMV NZ vaccination
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3828
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.185
Confidence Interval (2-Sided) 95%
0.809 to 1.737
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination
Hide Description The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Time Frame 31 days after MenACWY-CRM injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 981 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
6
(5 to 8)
5
(4 to 7)
Month 1 (N=956, 947)
6
(5 to 8)
6
(5 to 8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MenACWY, Control
Comments Vaccine Group Odds Ratios for carriage of combined N. meningitidis serogroups A, C, W, Y in the MenACWY-CRM group compared to Control group at 1 month after receiving 1 injection of MenACWY vaccine
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.840
Confidence Interval (2-Sided) 95%
0.555 to 1.273
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination
Hide Description The percentage of subjects with carriage of all (virulent + non-virulent) ST types of N. meningitidis B (genogroupable) in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 974 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
9
(8 to 11)
9
(7 to 11)
1 month post 1st vaccination (Day 31) N=931, 947
9
(7 to 11)
9
(7 to 11)
1 month post 2nd vaccination (Day 61) N=916, 928
11
(9 to 13)
10
(8 to 12)
3 months post 2nd vaccination (Day 121) N=860, 885
10
(8 to 12)
10
(8 to 12)
5 months post 2nd vaccination (Day 181) N=832, 864
9
(8 to 12)
10
(8 to 12)
11 months post 2nd vaccination (Day 361) N=797,827
8
(6 to 10)
10
(8 to 12)
4.Secondary Outcome
Title Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination
Hide Description Percentage of subjects with carriage of virulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 974 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
8
(6 to 10)
7
(6 to 9)
1 month post 1st vaccination (Day 31) N=931,947
8
(6 to 10)
8
(6 to 10)
1 month post 2nd vaccination (Day 61) N=916, 928
9
(8 to 12)
8
(6 to 10)
3 months post 2nd vaccination (Day 121) N=860, 885
9
(7 to 11)
9
(8 to 11)
5 months post 2nd vaccination (Day 181) N=832,864
9
(7 to 11)
9
(7 to 11)
11 months post 2nd vaccination (Day 361) N=797,827
8
(6 to 10)
9
(7 to 11)
5.Secondary Outcome
Title Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination
Hide Description Percentage of subjects with carriage of nonvirulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 974 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
1
(1 to 2)
1
(1 to 2)
1 month post 1st vaccination (N=931,947)
1
(0 to 2)
1
(0 to 2)
1 month post 2nd vaccination (N=916,928)
1
(1 to 2)
2
(1 to 3)
3 months post 2nd vaccination (N=860,885)
1
(0 to 2)
1
(0 to 2)
5 months post 2nd vaccination (N=832,864)
1
(0 to 2)
1
(0 to 2)
11 months post 2nd vaccination (N=797,827)
1
(0 to 1)
1
(0 to 2)
6.Secondary Outcome
Title Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination
Hide Description Percentage of subjects with carriage of all N.meningitidis strains combined in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 974 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
33
(31 to 37)
31
(28 to 34)
1 month post 1st vaccination (N=931, 947)
34
(31 to 37)
32
(29 to 35)
1 month post 2nd vaccination (N=916, 928)
38
(35 to 41)
36
(33 to 40)
3 months post 2nd vaccination (N=860, 885)
35
(32 to 39)
36
(33 to 39)
5 months post 2nd vaccination (N=832, 864)
34
(30 to 37)
36
(33 to 40)
11 months post 2nd vaccination (N=797, 827)
27
(24 to 30)
30
(27 to 34)
7.Secondary Outcome
Title Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination
Hide Description Percentages of subjects with carriage of N.meningitidis ABCWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 974 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
19
(17 to 22)
17
(15 to 19)
1 month post 1st vaccination (N=931, 947)
19
(17 to 22)
19
(16 to 21)
1 month post 2nd vaccination (N=916, 928)
22
(19 to 25)
22
(19 to 24)
3 months post 2nd vaccination (N=860, 885)
20
(17 to 23)
22
(19 to 25)
5 months post 2nd vaccination (N=832, 864)
19
(17 to 22)
23
(20 to 26)
11 months post 2nd vaccination (N=797, 827)
15
(12 to 17)
18
(15 to 20)
8.Secondary Outcome
Title Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination
Hide Description Percentages of subjects with carriage of N.meningitidis ACWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
Overall Number of Participants Analyzed 974 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
10
(8 to 12)
8
(7 to 10)
1 month post 1st vaccination (N=931, 947)
11
(9 to 13)
10
(8 to 12)
1 month post 2nd vaccination (N=916, 928)
11
(9 to 13)
12
(10 to 14)
3 months post 2nd vaccination (N=860, 885)
10
(8 to 12)
12
(10 to 14)
5 months post 2nd vaccination (N=832, 864)
10
(8 to 12)
13
(11 to 15)
11 months post 2nd vaccination (N=797, 827)
7
(5 to 8)
8
(6 to 10)
9.Secondary Outcome
Title Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination
Hide Description Percentages of subjects with carriage of N.meningitidis serogroups A,C,W or Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 974 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
7
(6 to 9)
5
(4 to 7)
1 month post 1st vaccination (N=931, 947)
7
(5 to 9)
6
(5 to 8)
1 month post 2nd vaccination (N=916, 928)
7
(5 to 9)
8
(6 to 10)
3 months post 2nd vaccination (N=860, 885)
6
(5 to 8)
8
(6 to 10)
5 months post 2nd vaccination (N=832, 864)
6
(5 to 8)
9
(7 to 11)
11 months post 2nd vaccination (N=797, 827)
5
(4 to 7)
5
(3 to 7)
10.Secondary Outcome
Title Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination
Hide Description Percentages of subjects with carriage of N.meningitidis genogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MIIT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 974 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
7
(6 to 9)
7
(5 to 9)
1 month post 1st vaccination (N=931, 947)
9
(7 to 11)
8
(7 to 10)
1 month post 2nd vaccination (N=916, 928)
9
(7 to 11)
10
(9 to 13)
3 months post 2nd vaccination (N=860, 885)
8
(6 to 10)
10
(8 to 12)
5 months post 2nd vaccination (N=832, 864)
8
(7 to 10)
10
(8 to 13)
11 months post 2nd vaccination (N=797, 827)
5
(4 to 7)
6
(5 to 8)
11.Secondary Outcome
Title Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination
Hide Description Percentages of subjects with carriage of N.meningitidis serogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 974 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
6
(4 to 7)
5
(3 to 6)
1 month post 1st vaccination (N=931, 947)
6
(4 to 8)
5
(4 to 7)
1 month post 2nd vaccination (N=916, 928)
5
(4 to 7)
7
(6 to 9)
3 months post 2nd vaccination (N=860, 885)
5
(4 to 7)
7
(5 to 9)
5 months post 2nd vaccination (N=832, 864)
6
(4 to 8)
7
(6 to 9)
11 months post 2nd vaccination (N=797, 827)
4
(3 to 6)
4
(3 to 6)
12.Secondary Outcome
Title Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination
Hide Description Percentages of subject with carriage of N. meningitidis genogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 981 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
9
(7 to 11)
8
(7 to 10)
1 month post 1 dose (N=956, 947)
10
(8 to 12)
10
(8 to 12)
2 months post 1 dose (N=929, 928)
9
(8 to 12)
12
(10 to 14)
4 months post 1 dose (N=884, 885)
10
(8 to 12)
12
(10 to 14)
6 months post 1 dose (N=867, 864)
11
(9 to 13)
13
(11 to 15)
12 months post 1 dose (N=845, 827)
8
(6 to 10)
8
(6 to 10)
13.Secondary Outcome
Title Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination
Hide Description Percentages of subjects with carriage of N. meningitidis serogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 981 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline (Day 1)
6
(5 to 8)
5
(4 to 7)
1 month post 1 dose (N=956, 947)
6
(5 to 8)
6
(5 to 8)
2 months post 1 dose (N=929, 928)
5
(4 to 7)
8
(6 to 10)
4 months post 1 dose (N=884, 885)
6
(5 to 8)
8
(6 to 10)
6 months post 1 dose (N=867, 864)
6
(5 to 8)
9
(7 to 11)
12 months post 1 dose (N=845, 827)
4
(3 to 6)
5
(3 to 7)
14.Secondary Outcome
Title Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination
Hide Description Percentages of subjects with carriage of N. meningitidis genogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 981 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
7
(5 to 8)
7
(5 to 9)
1 month post 1 dose (N=956, 947)
7
(6 to 9)
8
(7 to 10)
2 months post 1 dose (N=929, 928)
7
(6 to 9)
10
(9 to 13)
4 months post 1 dose (N=884, 885)
8
(6 to 10)
10
(8 to 12)
6 months post 1 dose (N=867, 864)
9
(7 to 11)
10
(8 to 13)
12 months post 1 dose (N=845, 827)
6
(5 to 8)
6
(5 to 8)
15.Secondary Outcome
Title Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination
Hide Description Percentages of subjects with carriage of N. meningitidis serogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 981 984
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline
4
(3 to 6)
5
(3 to 6)
1 month post 1 dose (N=956, 947)
5
(4 to 6)
5
(4 to 7)
2 months post 1 dose (N=929, 928)
4
(3 to 5)
7
(6 to 9)
4 months post 1 dose (N=884, 885)
5
(4 to 7)
7
(5 to 9)
6 months post 1 dose (N=867, 864)
5
(4 to 7)
7
(6 to 9)
12 months post 1 dose (N=845, 827)
4
(3 to 5)
4
(3 to 6)
16.Secondary Outcome
Title Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination
Hide Description The percentages of subjects with newly acquired pharyngeal carriage of all ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 748 786
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline non-carrier
90
(87 to 92)
91
(89 to 93)
1 month post 1st vaccination (N=671, 715)
3
(2 to 5)
4
(2 to 5)
1 month post 2nd vaccination (N=650, 687)
3
(2 to 5)
2
(1 to 3)
3 months post 2nd vaccination (N=628, 674)
1
(0 to 2)
3
(1 to 4)
5 months post 2nd vaccination (N=623, 656)
1
(1 to 3)
2
(1 to 4)
11 months post 2nd vaccination (N=614, 642)
3
(2 to 5)
3
(2 to 5)
At 3,5,11 months post 2nd vaccination (N=628,674)
5
(4 to 7)
7
(6 to 10)
17.Secondary Outcome
Title Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination
Hide Description The percentages of subjects with newly acquired pharyngeal carriage of virulent ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 748 786
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline non-carrier
91
(89 to 93)
92
(90 to 94)
1 month post 1st vaccination (N=682, 726)
3
(2 to 5)
3
(2 to 5)
1 month post 2nd vaccination (N=659, 699)
3
(2 to 5)
2
(1 to 3)
3 months post 2nd vaccination (N=638, 686)
1
(0 to 2)
2
(1 to 4)
5 months post 2nd vaccination (N=632, 670)
1
(1 to 3)
2
(1 to 3)
11 months post 2nd vaccination (N=623, 656)
3
(2 to 5)
2
(1 to 4)
At 3,5, 11 months post 2nd vaccination (N=638,686)
5
(4 to 7)
6
(5 to 9)
18.Secondary Outcome
Title Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination
Hide Description The percentages of subjects with newly acquired pharyngeal carriage of all N. meningitidis in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 748 786
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline non-carrier
77
(74 to 80)
80
(77 to 83)
1 month post 1st vaccination (N=578, 627)
17
(14 to 20)
18
(15 to 21)
1 month post 2nd vaccination (N=479, 513)
14
(11 to 18)
12
(9 to 15)
3 months post 2nd vaccination (N=410, 452)
9
(6 to 12)
13
(10 to 16)
5 months post 2nd vaccination (N=374, 395)
8
(5 to 11)
9
(6 to 12)
11 months post 2nd vaccination (N=344, 361)
11
(8 to 15)
14
(10 to 18)
At 3,5, 11 months post 2nd vaccination (N=410,452)
26
(21 to 30)
31
(27 to 35)
19.Secondary Outcome
Title Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination
Hide Description The percentages of subjects with newly acquired pharyngeal carriage of N. meningitidis genogroups ABCWY in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 748 786
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline non-carrier
82
(79 to 85)
84
(82 to 87)
1 month post 1st vaccination (N=611, 663)
9
(7 to 12)
10
(8 to 13)
1 month post 2nd vaccination (N=553, 592)
6
(4 to 8)
7
(5 to 9)
3 months post 2nd vaccination (N=519, 551)
4
(3 to 6)
7
(5 to 9)
5 months post 2nd vaccination (N=497, 515)
5
(3 to 7)
5
(3 to 7)
11 months post 2nd vaccination (N=472, 491)
6
(4 to 8)
6
(4 to 9)
At 3,5, 11 months post 2nd vaccination (N=519,551)
14
(11 to 18)
17
(14 to 20)
20.Secondary Outcome
Title Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination
Hide Description The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroups A,C, W or Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 794 786
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline non-carrier
94
(92 to 96)
95
(93 to 96)
1 month post 1st vaccination (N=746, 745)
4
(3 to 6)
5
(3 to 6)
1 month post 2nd vaccination (N=712, 709)
2
(1 to 3)
4
(3 to 6)
3 months post 2nd vaccination (N=701, 680)
2
(1 to 4)
3
(2 to 5)
5 months post 2nd vaccination (N=685, 660)
3
(2 to 4)
2
(1 to 3)
11 months post 2nd vaccination (N=666, 650)
2
(1 to 3)
1
(1 to 3)
1,3,5, 11 months post 2nd vaccination (N=712, 709)
8
(6 to 11)
10
(8 to 12)
21.Secondary Outcome
Title Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination
Hide Description The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroup Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 794 786
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline non-carrier
95
(94 to 97)
95
(94 to 97)
1 month post 1st vaccination (N=758, 749)
4
(2 to 5)
4
(3 to 6)
1 month post 2nd vaccination (N=730, 719)
1
(1 to 2)
4
(2 to 5)
3 months post 2nd vaccination (N=719, 693)
1
(1 to 3)
2
(1 to 4)
5 months post 2nd vaccination (N=709, 678)
2
(1 to 3)
1
(1 to 3)
11 months post 2nd vaccination (N=694, 669)
2
(1 to 3)
1
(1 to 3)
1,3,5, 11 months post 2nd vaccination (N=730, 719)
6
(5 to 8)
8
(6 to 10)
22.Secondary Outcome
Title The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV
Hide Description The duration of carriage of any N.meningitidis strains after receiving two doses of rMenB+OMV compared to that in the control group is reported.
Time Frame Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 440 470
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Number of days
Genogroup B All STs (N=152, 160)
127
(92 to 162)
146
(112 to 180)
Genogroup B virulent STs (N=142, 142)
122
(87 to 157)
147
(113 to 182)
All N meningitidis
193
(176 to 210)
202
(185 to 219)
Genogroups ABCWY (N=300, 323)
143
(122 to 164)
162
(141 to 183)
Serogroups ACWY (N=131, 142)
104
(79 to 129)
113
(87 to 138)
Serogroup Y (N=106, 123)
106
(79 to 132)
117
(91 to 144)
23.Secondary Outcome
Title The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM
Hide Description The duration of carriage of any N meningitidis strain after receiving one dose MenACWY-CRM as compared to that in control group is reported.
Time Frame Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 138 142
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Number of days
Serogroups ACWY
88
(62 to 114)
113
(87 to 138)
Serogroup Y (N=110, 123)
86
(59 to 114)
117
(91 to 144)
24.Secondary Outcome
Title The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine
Hide Description The duration of carriage after new acquisition of N.meningitidis strains after receiving two doses of rMenB+OMV vaccine compared to that in the control group is reported.
Time Frame Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 271 312
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Number of days
Genogroup B All STs (N=76, 89)
82
(44 to 120)
107
(71 to 142)
Genogroup B virulent STs (N=77, 82)
80
(42 to 117)
107
(70 to 143)
All N meningitidis
158
(135 to 181)
165
(142 to 188)
Genogroups ABCWY (N=165, 201)
121
(96 to 146)
146
(122 to 170)
Serogroups ACWY (N=75, 102)
111
(79 to 143)
120
(89 to 151)
Serogroup Y (N=61, 87)
111
(76 to 146)
120
(87 to 153)
25.Secondary Outcome
Title The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine
Hide Description The duration of carriage after new acquisition of N.meningitidis strains after receiving one dose of MenACWY-CRM vaccine compared to that in the control group is reported.
Time Frame Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 90 102
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Number of days
Serogroups ACWY
90
(57 to 123)
120
(89 to 151)
Serogroup Y (N=74, 87)
87
(52 to 122)
120
(87 to 153)
26.Secondary Outcome
Title Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination
Hide Description

The percentages of subjects with N. meningitidis Virulent ST of serogroup B, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<4 and ≥4) titers after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.

The serum bactericidal antibodies directed against N.meningitides serogroups, are measured by Serum Bactericidal Assay using human complement (hSBA).

H44/76, 5/99 and NZ98/254 are strains in serogroup B.

Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title rMenB+OMV Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 133 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
Baseline hSBA < 4 (H44/76) (N=60,19)
0
(0 to 6)
0
(0 to 18)
1month post 1st dose; hSBA<4(H44/76) (N=60, 18)
3
(0 to 12)
0
(0 to 19)
1month post 2nd dose; hSBA<4(H44/76) (N=60, 18)
7
(2 to 16)
0
(0 to 19)
3months post 2nd dose; hSBA<4(H44/76) (N=56, 17)
4
(0 to 12)
0
(0 to 20)
5 months post 2nd dose; hSBA <4(H44/76) (N=56, 17)
7
(2 to 17)
0
(0 to 20)
11 months post 2nd dose;hSBA <4(H44/76) (N=56, 16)
11
(4 to 22)
0
(0 to 21)
Baseline hSBA ≥4 (H44/76)
10
(5 to 16)
6
(1 to 21)
1month post 1st dose; hSBA ≥4 (H44/76) (N=130, 30)
5
(2 to 11)
10
(2 to 27)
1 month post 2nd dose;hSBA ≥4 (H44/76) (N=130, 30)
8
(4 to 14)
7
(1 to 22)
3 months post 2nd dose;hSBA ≥4 (H44/76) (N=120,29)
9
(5 to 16)
14
(4 to 32)
5 months post 2nd dose;hSBA ≥4 (H44/76) (N=115,28)
5
(2 to 11)
11
(2 to 28)
11 months post 2nd dose;hSBA ≥4 (H44/76)(N=123,30)
5
(2 to 10)
7
(1 to 22)
Baseline hSBA < 4 (5/99) (N=77, 23)
5
(1 to 13)
9
(1 to 28)
1month post 1st dose; hSBA<4 (5/99) (N=77, 22)
4
(1 to 11)
9
(1 to 29)
1 month post 2nd dose;hSBA <4 (5/99) (N=77, 22)
6
(2 to 15)
0
(0 to 15)
3 months post 2nd dose;hSBA <4 (5/99) (N=71, 21)
4
(1 to 12)
10
(1 to 30)
5 months post 2nd dose;hSBA <4 (5/99) (N=68, 21)
3
(0 to 10)
10
(1 to 30)
11 months post 2nd dose;hSBA <4(5/99) (N=71, 20)
7
(2 to 16)
5
(0 to 25)
Baseline hSBA ≥4 (5/99) (N=116, 27)
8
(4 to 14)
0
(0 to 13)
1month post 1st dose; hSBA ≥4 (5/99) (N=113, 26)
5
(2 to 11)
4
(0.097 to 20)
1 month post 2nd dose;hSBA ≥4 (5/99) (N=113, 26)
8
(4 to 15)
8
(1 to 25)
3 months post 2nd dose;hSBA ≥4 (5/99) (N=105, 25)
10
(5 to 17)
8
(1 to 26)
5 months post 2nd dose;hSBA ≥4 (5/99) (N=103, 24)
8
(3 to 15)
4
(0 to 21)
11 months post 2nd dose;hSBA ≥4(5/99) (N=108, 26)
6
(3 to 13)
4
(0.097 to 20)
Baseline hSBA < 4 (NZ98/254) (N=83, 31)
2
(0 to 8)
6
(1 to 21)
1month post 1st dose; hSBA<4(NZ98/254) (N=81, 30)
4
(1 to 10)
7
(1 to 22)
1month post 2nd dose; hSBA<4 (NZ98/254) (N=81, 30)
4
(1 to 10)
0
(0 to 12)
3 months post 2nd dose;hSBA <4 (NZ98/254)(N=75,29)
3
(0 to 9)
3
(0.087 to 18)
5 months post 2nd dose;hSBA <4 (NZ98/254)(N=70,29)
3
(0 to 10)
3
(0.087 to 18)
11 months post 2nd dose;hSBA <4(NZ98/254)(N=75,28)
11
(5 to 20)
4
(0.09 to 18)
Baseline hSBA ≥4 (NZ98/254) (N=110, 19)
10
(5 to 17)
0
(0 to 18)
1month post 1st dose; hSBA ≥4 (NZ98/254)(N=109,18)
6
(2 to 12)
6
(0 to 27)
1 month post 2nd dose;hSBA ≥4 (NZ98/254)(N=109,18)
10
(5 to 17)
11
(1 to 35)
3 months post 2nd dose;hSBA ≥4(NZ98/254)(N=101,17)
11
(6 to 19)
18
(4 to 43)
5 months post 2nd dose;hSBA ≥4(NZ98/254)(N=101,16)
8
(3 to 15)
13
(2 to 38)
11 months post 2nd dose;hSBA≥4(NZ98/254)(N=104,18)
4
(1 to 10)
6
(0 to 27)
27.Secondary Outcome
Title Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers
Hide Description The prevalence of carriage of N. meningitidis serogroup Y, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<8 and ≥8) titers, after administration of one dose of MenACWY-CRM vaccine as compared to the control group is reported.
Time Frame Up to 12 months after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Pharyngeal carriage)
Arm/Group Title MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 152 154
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline hSBA <8 (MenY) (N=42, 44)
0
(0 to 8)
0
(0 to 8)
1month post 1st dose; hSBA <8 (MenY) (N=39, 40)
0
(0 to 9)
3
(0.063 to 13)
1 month post 2nd dose;hSBA <8 (MenY) (N=39, 40)
0
(0 to 9)
0
(0 to 9)
3 months post 2nd dose;hSBA <8 (MenY) (N=36, 37)
0
(0 to 10)
3
(0.068 to 14)
5 months post 2nd dose;hSBA <8 (MenY) (N=36, 36)
0
(0 to 10)
6
(1 to 19)
11 months post 2nd dose;hSBA <8 (MenY) (N=34, 35)
3
(0.074 to 15)
6
(1 to 19)
Baseline hSBA ≥8 (MenY)
6
(3 to 11)
6
(3 to 11)
1month post 1st dose; hSBA ≥8 (MenY) (N=146,151)
6
(3 to 11)
5
(2 to 10)
1 month post 2nd dose;hSBA ≥8 (MenY) (N=143, 149)
5
(2 to 10)
5
(2 to 10)
3 months post 2nd dose;hSBA ≥8 (MenY) (N=131, 139)
8
(4 to 14)
7
(4 to 13)
5 months post 2nd dose;hSBA ≥8 (MenY) (N=130, 134)
9
(5 to 16)
5
(2 to 10)
11 months post 2nd dose;hSBA ≥8 (MenY) (N=129,135)
4
(1 to 9)
3
(1 to 7)
28.Secondary Outcome
Title Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group
Hide Description The percentages of subjects with hSBA titers ≥1:4 against the three strains of N. meningitidis B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Immunogenicity subset) i.e all enrolled subjects who actually received a study vaccination, provided at least one evaluable serum sample after vaccination and whose assay result was available for at least one serogroup.
Arm/Group Title rMenB+OMV MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 193 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline H44/76
69
(62 to 75)
71
(57 to 83)
62
(47 to 75)
1 month post 2nd dose (H44/76) (N=189, 45, 48)
100
(98 to 100)
76
(60 to 87)
63
(47 to 76)
3 months post 2nd dose (H44/76) (N=173, 40, 46)
99
(97 to 100)
73
(56 to 85)
65
(50 to 79)
5 months post 2nd dose (H44/76) (N=169, 43, 45)
100
(98 to 100)
74
(59 to 86)
67
(51 to 80)
11 months post 2nd dose (H44/76) (N=177, 41, 46)
95
(91 to 98)
76
(60 to 88)
70
(54 to 82)
Baseline 5/99
60
(53 to 67)
45
(31 to 60)
54
(39 to 68)
1 month post 2nd dose (5/99) (N=189, 45, 48)
100
(98 to 100)
40
(26 to 56)
58
(43 to 72)
3 months post 2nd dose (5/99) (N=173, 40, 46)
99
(97 to 100)
49
(33 to 65)
53
(38 to 68)
5 months post 2nd dose (5/99) (N=169, 43, 45)
99
(97 to 100)
49
(33 to 65)
53
(38 to 68)
11 months post 2nd dose (5/99) (N=177, 41, 46)
97
(94 to 99)
51
(35 to 67)
63
(48 to 77)
Baseline NZ98/254
57
(50 to 64)
53
(38 to 67)
38
(25 to 53)
1 month post 2nd dose (NZ98/254) (N=189, 45, 48)
99
(97 to 100)
53
(38 to 68)
44
(29 to 59)
3 months post 2nd dose (NZ98/254) (N=173, 40, 46)
93
(88 to 96)
48
(32 to 64)
48
(33 to 63)
5 months post 2nd dose (NZ98/254) (N=169, 43, 45)
91
(85 to 94)
58
(42 to 73)
42
(28 to 58)
11 months post 2nd dose (NZ98/254) (N=177, 41, 46)
85
(79 to 90)
66
(49 to 80)
43
(29 to 59)
29.Secondary Outcome
Title The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
Hide Description The hSBA Geometric Mean Titers (GMTs) against the three strains of N. meningitidis serogroup B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.
Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Immunogenicity subset)
Arm/Group Title rMenB+OMV MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 193 49 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Baseline H44/76
11
(8.74 to 14)
11
(6.59 to 18)
9.42
(5.73 to 15)
1 month post 2nd dose (H44/76) (N=189, 45, 48)
229
(192 to 274)
11
(7.92 to 16)
10
(7.18 to 15)
3 months post 2nd dose (H44/76) (N=173, 40, 46)
144
(116 to 178)
9.07
(5.79 to 14)
11
(7.07 to 16)
5 months post 2nd dose (H44/76) (N=169, 43, 45)
111
(89 to 138)
12
(7.57 to 18)
12
(7.62 to 18)
11 months post 2nd dose (H44/76) (N=177, 40, 46)
68
(54 to 84)
14
(8.84 to 22)
14
(8.97 to 21)
Baseline 5/99
6.44
(5.1 to 8.13)
3.12
(1.97 to 4.95)
5.49
(3.47 to 8.67)
1 month post 2nd dose (5/99) (N=189, 45, 48)
424
(355 to 507)
2.63
(1.83 to 3.79)
5.62
(3.95 to 8.01)
3 months post 2nd dose (5/99) (N=173, 40, 46)
169
(139 to 207)
2.95
(1.94 to 4.47)
5.6
(3.8 to 8.26)
5 months post 2nd dose (5/99) (N=169, 43, 45)
105
(87 to 128)
3.36
(2.27 to 4.97)
5.32
(3.63 to 7.79)
11 months post 2nd dose (5/99) (N=177, 41, 46)
55
(45 to 67)
3.58
(2.37 to 5.4)
5.98
(4.05 to 8.82)
Baseline NZ98/254
6.15
(4.82 to 7.84)
4.32
(2.66 to 7)
4.16
(2.58 to 6.72)
1 month post 2nd dose (NZ98/254) (N=188, 45, 48)
99
(80 to 122)
4.82
(3.11 to 7.47)
3.88
(2.54 to 5.93)
3 months post 2nd dose (NZ98/254) (N=172, 40, 46)
56
(44 to 73)
4.93
(2.89 to 8.4)
4.72
(2.87 to 7.76)
5 months post 2nd dose (NZ98/254) (N=169, 43, 45)
50
(38 to 66)
6.5
(3.73 to 11)
4.67
(2.72 to 8.03)
11 months post 2nd dose (NZ98/254) (N=176, 41, 44)
34
(26 to 45)
7.77
(4.38 to 14)
6.93
(3.99 to 12)
30.Secondary Outcome
Title Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
Hide Description

The percentages of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.

As serogroup A and W strains were not detected in substantial proportion of subjects during pharyngeal carriage analysis, these serogroups were not tested.

Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Immunogenicity subset)
Arm/Group Title rMenB+OMV MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 193 194 198
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline Men C (N= 49, 194,50)
90
(78 to 97)
87
(81 to 91)
80
(66 to 90)
1 month post 2nd dose (Men C) (N=48, 182, 48)
98
(89 to 100)
99
(96 to 100)
88
(75 to 95)
11 months post 2nd dose (Men C) (N=48, 158, 41)
94
(83 to 99)
97
(93 to 99)
88
(74 to 96)
Baseline Men Y
72
(65 to 78)
78
(72 to 84)
78
(71 to 83)
1 month post 2nd dose (Men Y) (N=187, 182, 188)
81
(74 to 86)
95
(90 to 97)
82
(76 to 88)
3 months post 2nd dose (Men Y) (N=173,164,175)
79
(72 to 85)
95
(90 to 97)
82
(75 to 87)
5 months post 2nd dose (Men Y) (N=170, 165, 170)
78
(71 to 84)
92
(87 to 96)
84
(77 to 89)
11 months post 2nd dose (Men Y) (N=177, 158, 165)
77
(71 to 83)
91
(86 to 95)
81
(74 to 87)
31.Secondary Outcome
Title The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
Hide Description

The hSBA antibody titers against N. meningitidis serogroups C and Y after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group, are reported as GMTs.

Serogroups A and W were not analysed.

Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Immunogenicity subset)
Arm/Group Title rMenB+OMV MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 193 194 198
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Baseline Men C (N=49, 194, 50)
43
(26 to 70)
50
(39 to 65)
32
(20 to 53)
1 month post 2nd dose (Men C) (N=48, 182, 48)
83
(55 to 126)
1302
(1050 to 1615)
37
(24 to 56)
11 months post 2nd dose (MenC) (N=48, 158, 41)
59
(38 to 91)
438
(343 to 560)
41
(25 to 66)
Baseline Men Y
18
(14 to 22)
19
(15 to 23)
19
(15 to 23)
1 month post 2nd dose (Men Y) (N=187, 182, 188)
26
(21 to 32)
83
(67 to 103)
23
(18 to 28)
3 months post 2nd dose (Men Y) (N=173, 164, 175)
24
(19 to 30)
69
(56 to 86)
22
(17 to 27)
5 months post 2nd dose (Men Y (N=170, 165, 170)
23
(19 to 29)
63
(51 to 78)
22
(18 to 28)
11 months post 2nd dose (Men Y) (N=177, 158, 165)
21
(17 to 26)
49
(39 to 61)
22
(17 to 27)
32.Secondary Outcome
Title Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group.
Hide Description

The percentages of subjects with hSBA seroresponse against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination as compared to the control group are reported.

Seroresponse to N. meningitidis serogroups Cand Y is defined as :(1)for subjects with a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer ≥ 1:8 or (2) for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.

Analysis was not done for serogroups A and W.

Time Frame 61 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Immunogenicity subset)
Arm/Group Title rMenB+OMV MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 187 181 188
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
1 month post 2nd dose from day 1(Men C)N=48,181,48
8
(2 to 20)
81
(75 to 87)
4
(1 to 14)
1 month post 2nd dose from day 1(Men Y)
12
(8 to 17)
44
(37 to 52)
7
(4 to 12)
33.Secondary Outcome
Title The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group
Hide Description

The hSBA geometric mean titers against the N. meningitidis serogroups C and Y in subjects (who have received a prior dose of MenC vaccine) after MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.

Analysis was not done for serogroups A and W.

Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Immunogenicity subset)
Arm/Group Title MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
Overall Number of Participants Analyzed 46 26
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Baseline (Men C) (N=46, 6)
91
(51 to 160)
157
(33 to 756)
1 month post 2nd vaccination (Men C) (N=45, 6)
1905
(1305 to 2779)
154
(55 to 434)
11 months post 2nd vaccination (Men C) (N=45, 6)
691
(464 to 1028)
125
(42 to 371)
Baseline (Men Y)
21
(13 to 32)
23
(13 to 41)
1 month post 2nd vaccination (Men Y) (N=45, 26)
89
(55 to 142)
19
(10 to 36)
3 months post 2nd vaccination (Men Y) (N=42, 25)
67
(41 to 110)
20
(11 to 38)
5 months post 2nd vaccination (Men Y) (N=45, 26)
65
(41 to 103)
20
(11 to 37)
11 months post 2nd vaccination (Men Y) (N=45, 26)
48
(31 to 76)
22
(12 to 39)
34.Secondary Outcome
Title Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group.
Hide Description

The percentages of subjects (who have received a prior dose of MenC vaccine) with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y after receiving MenACWY-CRM vaccination in this study as compared to the control group are reported.

Analysis was not done for serogroups A and W.

Time Frame Up to 361 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the MITT dataset (Immunogenicity subset)
Arm/Group Title MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
Overall Number of Participants Analyzed 46 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline (Men C) (N=46,6)
93
(82 to 99)
100
(54 to 100)
1 month post 2nd vaccination (Men C) (N=45, 6)
100
(92 to 100)
100
(54 to 100)
11 months post 2nd vaccination (Men C) (N=45, 6)
100
(92 to 100)
100
(54 to 100)
Baseline (Men Y)
80
(66 to 91)
81
(61 to 93)
1 month post 2nd vaccination (Men Y) (N=45, 26)
96
(85 to 99)
77
(56 to 91)
3 months post 2nd vaccination (Men Y) (N=42, 25)
95
(84 to 99)
80
(59 to 93)
5 months post 2nd vaccination (Men Y) (N=45, 26)
96
(85 to 99)
77
(56 to 91)
11 months post 2nd vaccination (Men Y) (N=45, 26)
91
(79 to 98)
77
(56 to 91)
35.Secondary Outcome
Title Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group
Hide Description The safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group rMenB+OMV) and one dose of MenACWY-CRM vaccine (Group MenACWY) was assessed in terms of number of subjects with solicited local and systemic adverse events and other adverse events, following vaccination and compared to that of the control group.
Time Frame Day 1 through day 7 after any vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Immunogenicity Subset, Safety Population i.e. all subjects in the exposed population who provided postvaccination safety data.
Arm/Group Title rMenB+OMV MenACWY Control
Hide Arm/Group Description:
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Number of Participants Analyzed 190 187 191
Measure Type: Number
Unit of Measure: number of subjects
Any local 184 158 139
Injection site pain (N=190, 186,191) 181 143 117
Injection site erythema (N=190, 186, 191) 100 71 61
Injection site induration (N=190, 186, 191) 68 41 21
Injection site swelling (N=190, 186, 191) 68 31 23
Any systemic 169 133 140
Arthralgia (N=190, 186, 191) 38 27 29
Nausea (N=190, 186, 191) 36 23 24
Malaise (N=190, 186, 191) 57 41 46
Myalgia (N=190, 186, 191) 155 117 112
Headache (N=190, 186, 191) 71 56 75
Rash (N=190, 186, 191) 9 9 12
Fever (≥38°C) (N= 190, 186,191) 7 5 7
Any Other 64 22 25
Temperature (≥40°C) (N= 190, 186, 191) 0 0 0
Antipyretic preventive med. used (N=190, 186, 191) 20 7 3
Antipyretic treatment med. used (N=190, 186, 191) 55 17 22
Time Frame Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361)
Adverse Event Reporting Description The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
 
Arm/Group Title rMenB+OMV MenACWY Control
Hide Arm/Group Description Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
All-Cause Mortality
rMenB+OMV MenACWY Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
rMenB+OMV MenACWY Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/974 (3.18%)   26/984 (2.64%)   20/985 (2.03%) 
Cardiac disorders       
Palpitations * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Endocrine disorders       
Thyroiditis acute * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  1/974 (0.10%)  3/984 (0.30%)  0/985 (0.00%) 
General disorders       
Edema peripheral * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Pyrexia * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Immune system disorders       
Anaphylactic reaction * 1  1/974 (0.10%)  1/984 (0.10%)  0/985 (0.00%) 
Infections and infestations       
Acute tonsillitis * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Appendiceal abscess * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Appendicitis * 1  1/974 (0.10%)  3/984 (0.30%)  1/985 (0.10%) 
Cellulitis * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Diarrhea infectious * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Gastroenteritis * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Gastroenteritis viral * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Genital abscess * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Infectious mononucleosis * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Influenza * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Kidney infection * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Leptospirosis * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Pelvic inflammatory disease * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Peritonitis * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Peritonsillar abscess * 1  1/974 (0.10%)  0/984 (0.00%)  1/985 (0.10%) 
Pilonidal cyst * 1  0/974 (0.00%)  2/984 (0.20%)  0/985 (0.00%) 
Pyelonephritis * 1  3/974 (0.31%)  0/984 (0.00%)  0/985 (0.00%) 
Tonsillitis * 1  2/974 (0.21%)  0/984 (0.00%)  0/985 (0.00%) 
Tracheitis * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Upper respiratory tract infection * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Urinary tract infection * 1  2/974 (0.21%)  0/984 (0.00%)  0/985 (0.00%) 
Varicella * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Viral infection * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Viral pharyngitis * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Viral rash * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Injury, poisoning and procedural complications       
Ankle fracture * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Burns third degree * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Cartilage injury * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Clavicle fracture * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Contusion * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Facial bones fracture * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Fall * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Fibula fracture * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Foot fracture * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Forearm fracture * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Head injury * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Jaw fracture * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Joint dislocation * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Joint injury * 1  0/974 (0.00%)  1/984 (0.10%)  1/985 (0.10%) 
Laceration * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Ligament rupture * 1  0/974 (0.00%)  1/984 (0.10%)  1/985 (0.10%) 
Lower limb fracture * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Lumbar vertebral fracture * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Meniscus lesion * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Multiple drug overdose * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Overdose * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Patella fracture * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Pelvic fracture * 1  0/974 (0.00%)  1/984 (0.10%)  1/985 (0.10%) 
Spinal compression fracture * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Spinal fracture * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Tendon rupture * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Tibia fracture * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Traumatic fracture * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Traumatic liver injury * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Ulna fracture * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Metabolism and nutrition disorders       
Hypoglycaemia * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Muscloskeletal chest pain * 1  0/974 (0.00%)  1/984 (0.10%)  1/985 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Carcinoid tumor pulmonary * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Ovarian germ cell cancer stage IV * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Nervous system disorders       
Convulsion * 1  1/974 (0.10%)  1/984 (0.10%)  0/985 (0.00%) 
Migraine * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Tremor * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Ectopic pregnancy * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Psychiatric disorders       
Suicidal ideation * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Renal and urinary disorders       
IGA Nephropathy * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Pelvic-ureteric obstruction * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Reproductive system and breast disorders       
Cervical dysplasia * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Vulval disorder * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  0/974 (0.00%)  2/984 (0.20%)  0/985 (0.00%) 
Dyspnea * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
Pneumothorax * 1  0/974 (0.00%)  0/984 (0.00%)  1/985 (0.10%) 
Skin and subcutaneous tissue disorders       
Skin lesion * 1  0/974 (0.00%)  1/984 (0.10%)  0/985 (0.00%) 
Surgical and medical procedures       
Appendicectomy * 1  0/974 (0.00%)  1/984 (0.10%)  1/985 (0.10%) 
Ligament operation * 1  1/974 (0.10%)  0/984 (0.00%)  0/985 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
rMenB+OMV MenACWY Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   200/974 (20.53%)   186/984 (18.90%)   172/985 (17.46%) 
General disorders       
Injection site erythema  1  102/974 (10.47%)  71/984 (7.22%)  61/985 (6.19%) 
Injection site induration  1  68/974 (6.98%)  42/984 (4.27%)  21/985 (2.13%) 
Injection site pain  1  182/974 (18.69%)  145/984 (14.74%)  117/985 (11.88%) 
Injection site swelling  1  68/974 (6.98%)  32/984 (3.25%)  23/985 (2.34%) 
Malaise  1  58/974 (5.95%)  43/984 (4.37%)  47/985 (4.77%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  155/974 (15.91%)  119/984 (12.09%)  112/985 (11.37%) 
Nervous system disorders       
Headache  1  82/974 (8.42%)  67/984 (6.81%)  85/985 (8.63%) 
Indicates events were collected by 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
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01214850     History of Changes
Other Study ID Numbers: V72_29
First Submitted: September 30, 2010
First Posted: October 5, 2010
Results First Submitted: September 4, 2013
Results First Posted: January 23, 2014
Last Update Posted: April 21, 2016