Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules
Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT00661713
Collaborator
(none)
1,631
10
8
30
163.1
5.4
Study Details
Study Description
Brief Summary
The proposed study is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1631 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
A Phase 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules
Study Start Date
:
Jun 1, 2008
Actual Primary Completion Date
:
Apr 1, 2010
Actual Study Completion Date
:
Dec 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: rMenB06 Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and two injections of placebo (at month 1, month 2). A second injection of rMenB+OMV NZ vaccine was given later (month 6). |
Biological: rMenB+OMV NZ
Other Names:
Biological: Placebo
|
| Experimental: rMenB0 Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6). |
Biological: rMenB+OMV NZ
Other Names:
Biological: Placebo
|
| Experimental: rMenB016 Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6). |
Biological: rMenB+OMV NZ
Other Names:
Biological: Placebo
|
| Experimental: rMenB01 Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and two injection of placebo (at month 2 and month 6). |
Biological: rMenB+OMV NZ
Other Names:
Biological: Placebo
|
| Experimental: rMenB026 Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6). |
Biological: rMenB+OMV NZ
Other Names:
Biological: Placebo
|
| Experimental: rMenB02 Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and two injections of placebo (at month 1 and month 6). |
Biological: rMenB+OMV NZ
Other Names:
Biological: Placebo
|
| Experimental: rMenB012 Subjects received three injections of rMenB+OMV NZ vaccine (at month 0, month 1 and month 2) and one injection of placebo later (at month 6). |
Biological: rMenB+OMV NZ
Other Names:
Biological: Placebo
|
| Experimental: rMenB6 Subjects received three injections of placebo(at month 0, month 1 and month 2) and one injection of rMenB+OMV NZ vaccine(at month 6). |
Biological: rMenB+OMV NZ
Other Names:
Biological: Placebo
|
Outcome Measures
Primary Outcome Measures
- Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine. [Month-1, 2, 3]
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.
- Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination [1 to 7 days after each vaccination]
Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV
Secondary Outcome Measures
- Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6. [Month-6 & 7]
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 & 7.
- Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination. [at baseline, month-1, month-2, month-3, month-6 and month-7.]
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.
- Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination. [Month-1, month-2, month-3 and month-7]
Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.
- Geometric Mean Titers (GMTs) After Primary and Booster Vaccination. [month-1, month-2, month-3, month-6 and month-7]
Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
- Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination. [month-1, month-2, month-3, month-6 and month-7]
Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
- GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination. [month-1, month-2, month-3, month-6 and month-7]
Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.
- GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination [month-1, month-2, month-3, month-6 and month-7]
Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen
- Number of Subjects Reporting Unsolicited AEs Throughout the Study. [Throughout the study]
Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.
Eligibility Criteria
Criteria
Ages Eligible for Study:
11 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
1)11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment;
2)who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
3)in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Exclusion Criteria:
-
History of any meningococcal B vaccine administration;
-
Current or previous, confirmed or suspected disease caused by N. meningitidis;
-
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
-
Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥38°C) within the previous day;
-
Antibiotics within 6 days prior to enrollment;
-
Pregnancy or nursing (breastfeeding) mothers;
-
Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 7 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
-
Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
-
Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants;
-
Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
-
History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
-
Receipt of or intent to immunize with any other vaccine(s) within 30 days prior (60 days for live viral vaccines) and throughout the study period (exception: licensed fluvaccine should not be administered within 14 days prior to enrollment; routine vaccine administration may be administered after the blood draw at Study Month 7);
-
Participation in another clinical trial within the last 90 days or planned for during study;
-
Family members and household members of research staff;
-
Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site 13: Liceo Diego Aracena de Lo Barnechea | Monseñor Escrivá De Balaguer 14630, Lo Barnechea | Santiago | Chile | |
| 2 | Site 41: Colegio Antonio Hermida Fabres | Av. Coronel Alejandro Sepúlveda N° 6801 | Chile | ||
| 3 | Site 43: Liceo José Victorino Lastarria | Av. Miguel Claro N° 32 | Chile | ||
| 4 | Site 51: Centro Para vacunas en Desarrollo. Hospital de Niños Roberto del Rio | Av. Prof Zañartu 1085 | Chile | ||
| 5 | Site 15: Liceo Carmela Carvajal de Prat | Avda. Italia 980 | Chile | ||
| 6 | Site 14: Colegio Parroquial Santa Rosa de Lo Barnechea | Avda. Raúl Labbé Nº 13.799 | Chile | ||
| 7 | Site 42: Centro Educacional Eduardo de la Barra | Calle A, N° 6301 | Chile | ||
| 8 | Site 61: Facultad de Medicina. Universidad de Valparaíso. | Hontaneda # 2653. Valparaíso | Chile | ||
| 9 | Site 11: Complejo Educacional Eduardo Cuevas Valdés | Lo Barnechea | Chile | ||
| 10 | Site 12: Colegio San Jose de Lo Barnechea | Santiago | Chile |
Sponsors and Collaborators
- Novartis Vaccines
Investigators
- Study Chair: Novartis Vaccines, Novartis Vaccines
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00661713
Other Study ID Numbers:
- V72P10
First Posted:
Apr 18, 2008
Last Update Posted:
Mar 20, 2019
Last Verified:
Mar 1, 2019
Keywords provided by Novartis Vaccines
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were enrolled at 10 study centers in Chile. |
|---|---|
| Pre-assignment Detail | All enrolled subjects were included in the trial. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. |
| Period Title: Overall Study | ||||||||
| STARTED | 128 | 247 | 128 | 247 | 127 | 253 | 373 | 128 |
| COMPLETED | 112 | 208 | 111 | 219 | 107 | 216 | 309 | 117 |
| NOT COMPLETED | 16 | 39 | 17 | 28 | 20 | 37 | 64 | 11 |
Baseline Characteristics
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. | Total of all reporting groups |
| Overall Participants | 128 | 247 | 128 | 247 | 127 | 253 | 373 | 128 | 1631 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
13.8
(1.9)
|
13.8
(1.9)
|
13.9
(1.9)
|
13.9
(1.9)
|
13.7
(1.9)
|
13.7
(1.8)
|
13.8
(1.9)
|
13.8
(2)
|
13.8
(1.9)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
76
59.4%
|
147
59.5%
|
76
59.4%
|
138
55.9%
|
73
57.5%
|
138
54.5%
|
199
53.4%
|
66
51.6%
|
913
56%
|
| Male |
52
40.6%
|
100
40.5%
|
52
40.6%
|
109
44.1%
|
54
42.5%
|
115
45.5%
|
174
46.6%
|
62
48.4%
|
718
44%
|
Outcome Measures
| Title | Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine. |
|---|---|
| Description | Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3. |
| Time Frame | Month-1, 2, 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed as per the protocol dataset |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. |
| Measure Participants | 112 | 223 | 113 | 231 | 110 | 232 | 334 | 116 |
| 44/76-SL- Mo 0 |
42
|
47
|
41
|
38
|
37
|
47
|
46
|
46
|
| 44/76-SL- Mo 1 |
92
|
92
|
95
|
93
|
90
|
92
|
95
|
43
|
| 44/76-SL- Mo 2 |
88
|
92
|
100
|
100
|
88
|
89
|
100
|
50
|
| 44/76-SL- Mo 3 |
84
|
88
|
99
|
100
|
100
|
100
|
100
|
48
|
| 5/99- Mo 0 |
29
|
41
|
28
|
31
|
30
|
37
|
36
|
29
|
| 5/99- Mo 1 |
97
|
96
|
96
|
97
|
97
|
95
|
97
|
35
|
| 5/99- Mo 2 |
95
|
94
|
100
|
100
|
97
|
96
|
100
|
31
|
| 5/99- Mo 3 |
92
|
89
|
99
|
100
|
98
|
100
|
100
|
32
|
| NZ98/254-mo 0 |
32
|
39
|
33
|
35
|
34
|
37
|
33
|
38
|
| NZ98/254-mo 1 |
90
|
94
|
95
|
94
|
90
|
93
|
95
|
38
|
| NZ98/254-mo 2 |
81
|
84
|
99
|
100
|
78
|
85
|
100
|
39
|
| NZ98/254-mo 3 |
80
|
76
|
97
|
97
|
100
|
100
|
99
|
43
|
| Title | Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination |
|---|---|
| Description | Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV |
| Time Frame | 1 to 7 days after each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed as per the safety dataset. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. |
| Measure Participants | 128 | 247 | 128 | 247 | 127 | 253 | 373 | 128 |
| erythema (local) |
93
72.7%
|
162
65.6%
|
95
74.2%
|
188
76.1%
|
94
74%
|
172
68%
|
282
75.6%
|
85
66.4%
|
| Induration (Local) |
71
55.5%
|
130
52.6%
|
75
58.6%
|
151
61.1%
|
82
64.6%
|
121
47.8%
|
228
61.1%
|
57
44.5%
|
| Swelling (Local) |
72
56.3%
|
132
53.4%
|
81
63.3%
|
144
58.3%
|
76
59.8%
|
115
45.5%
|
226
60.6%
|
54
42.2%
|
| Pain (Local) |
122
95.3%
|
236
95.5%
|
124
96.9%
|
237
96%
|
113
89%
|
236
93.3%
|
345
92.5%
|
123
96.1%
|
| Med.Att Fever (Systemic) |
1
0.8%
|
0
0%
|
2
1.6%
|
0
0%
|
1
0.8%
|
1
0.4%
|
1
0.3%
|
1
0.8%
|
| Malaise (Systemic) |
92
71.9%
|
181
73.3%
|
96
75%
|
172
69.6%
|
87
68.5%
|
185
73.1%
|
272
72.9%
|
89
69.5%
|
| Myalgia(Systemic) |
85
66.4%
|
141
57.1%
|
91
71.1%
|
156
63.2%
|
81
63.8%
|
160
63.2%
|
238
63.8%
|
91
71.1%
|
| Arthralgia(Systemic) |
55
43%
|
76
30.8%
|
55
43%
|
80
32.4%
|
39
30.7%
|
105
41.5%
|
146
39.1%
|
43
33.6%
|
| Headache(Systemic) |
79
61.7%
|
139
56.3%
|
88
68.8%
|
160
64.8%
|
73
57.5%
|
165
65.2%
|
244
65.4%
|
74
57.8%
|
| Nausea(Systemic) |
41
32%
|
80
32.4%
|
51
39.8%
|
72
29.1%
|
42
33.1%
|
88
34.8%
|
143
38.3%
|
49
38.3%
|
| Fever(Systemic) |
12
9.4%
|
8
3.2%
|
11
8.6%
|
21
8.5%
|
18
14.2%
|
26
10.3%
|
38
10.2%
|
18
14.1%
|
| Title | Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6. |
|---|---|
| Description | Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 & 7. |
| Time Frame | Month-6 & 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed as per the protocol dataset. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. |
| Measure Participants | 100 | 188 | 100 | 198 | 99 | 201 | 278 | 100 |
| 44/76-SL- Mo 6 |
76
|
72
|
93
|
92
|
97
|
98
|
97
|
46
|
| 44/76-SL- Mo 7 |
100
|
71
|
100
|
90
|
100
|
95
|
95
|
93
|
| 5/99- Mo 6 |
79
|
74
|
99
|
98
|
99
|
100
|
100
|
28
|
| 5/99- Mo 7 |
99
|
67
|
100
|
98
|
100
|
99
|
99
|
93
|
| NZ98/254-mo 6 |
81
|
69
|
93
|
89
|
97
|
96
|
97
|
45
|
| NZ98/254-mo 7 |
100
|
67
|
100
|
85
|
100
|
94
|
95
|
93
|
| Title | Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination. |
|---|---|
| Description | Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains. |
| Time Frame | at baseline, month-1, month-2, month-3, month-6 and month-7. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed as per the protocol dataset. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. |
| Measure Participants | 112 | 223 | 113 | 231 | 110 | 232 | 334 | 116 |
| 44/76-SL- Mo 0 |
29
|
37
|
31
|
32
|
30
|
35
|
33
|
33
|
| 44/76-SL- Mo 1 |
87
|
87
|
85
|
85
|
81
|
87
|
86
|
30
|
| 44/76-SL- Mo 2 |
79
|
84
|
99
|
99
|
80
|
80
|
99
|
33
|
| 44/76-SL- Mo 3 |
74
|
77
|
99
|
98
|
99
|
100
|
99
|
36
|
| 44/76-SL- Mo 6 |
62
|
62
|
90
|
83
|
90
|
91
|
93
|
34
|
| 44/76-SL- Mo 7 |
99
|
57
|
100
|
82
|
100
|
88
|
91
|
89
|
| 5/99- Mo 0 |
18
|
24
|
20
|
22
|
23
|
22
|
22
|
14
|
| 5/99- Mo 1 |
96
|
91
|
89
|
94
|
91
|
93
|
94
|
19
|
| 5/99- Mo 2 |
89
|
85
|
100
|
100
|
78
|
88
|
99
|
17
|
| 5/99- Mo 3 |
81
|
77
|
99
|
100
|
98
|
100
|
100
|
19
|
| 5/99- Mo 6 |
60
|
57
|
97
|
98
|
98
|
99
|
99
|
16
|
| 5/99- Mo 7 |
99
|
48
|
100
|
97
|
100
|
97
|
98
|
86
|
| NZ98/254 Mo 0 |
22
|
30
|
27
|
25
|
24
|
26
|
25
|
29
|
| NZ98/254 Mo 1 |
84
|
83
|
82
|
84
|
75
|
80
|
86
|
26
|
| NZ98/254 Mo 2 |
72
|
70
|
98
|
99
|
65
|
75
|
99
|
31
|
| NZ98/254 Mo 3 |
70
|
65
|
90
|
91
|
98
|
100
|
98
|
30
|
| NZ98/254 Mo 6 |
60
|
54
|
80
|
77
|
86
|
86
|
91
|
38
|
| NZ98/254 Mo 7 |
99
|
49
|
99
|
71
|
100
|
81
|
84
|
86
|
| Title | Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination. |
|---|---|
| Description | Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7. |
| Time Frame | Month-1, month-2, month-3 and month-7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed as per the protocol dataset. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. |
| Measure Participants | 112 | 223 | 113 | 231 | 110 | 232 | 333 | 115 |
| 44/76-SL Mo 1 |
73
|
75
|
71
|
77
|
67
|
73
|
72
|
3
|
| 44/76-SL Mo 2 |
62
|
67
|
94
|
96
|
65
|
61
|
94
|
6
|
| 44/76-SL Mo 3 |
53
|
59
|
88
|
91
|
91
|
95
|
95
|
3
|
| 44/76-SL Mo 7 |
95
|
33
|
98
|
73
|
93
|
76
|
80
|
76
|
| 5/99 Mo 1 |
87
|
79
|
81
|
85
|
79
|
85
|
85
|
3
|
| 5/99 Mo 2 |
78
|
65
|
98
|
98
|
63
|
74
|
98
|
5
|
| 5/99 Mo 3 |
65
|
53
|
95
|
99
|
96
|
99
|
99
|
6
|
| 5/99- Mo 7 |
98
|
27
|
99
|
88
|
99
|
90
|
94
|
82
|
| NZ98/254 Mo 1 |
72
|
70
|
65
|
74
|
59
|
64
|
73
|
3
|
| NZ98/254 Mo 2 |
57
|
52
|
89
|
93
|
51
|
57
|
93
|
7
|
| NZ98/254 Mo 3 |
50
|
43
|
78
|
81
|
91
|
91
|
93
|
6
|
| NZ98/254 Mo 7 |
94
|
27
|
95
|
62
|
92
|
69
|
75
|
77
|
| Title | Geometric Mean Titers (GMTs) After Primary and Booster Vaccination. |
|---|---|
| Description | Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254. |
| Time Frame | month-1, month-2, month-3, month-6 and month-7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed as per the protocol dataset. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. |
| Measure Participants | 112 | 223 | 113 | 231 | 110 | 232 | 334 | 116 |
| 44/76 GMT Mo 0 |
3.41
|
4.24
|
3.34
|
3.35
|
3.39
|
3.99
|
3.87
|
3.89
|
| 44/76 GMT Mo 1 |
46
|
58
|
56
|
52
|
44
|
57
|
60
|
3.39
|
| 44/76 GMT Mo 2 |
31
|
41
|
182
|
187
|
28
|
38
|
193
|
4.09
|
| 44/76 GMT Mo 3 |
20
|
31
|
132
|
114
|
182
|
230
|
240
|
4.04
|
| 44/76 GMT Mo 6 |
13
|
15
|
59
|
50
|
54
|
75
|
86
|
3.9
|
| 44/76 GMT Mo 7 |
218
|
12
|
324
|
36
|
259
|
48
|
59
|
56
|
| 5/99 GMT Mo 0 |
2.61
|
3.15
|
2.59
|
2.52
|
2.43
|
2.72
|
2.58
|
2.27
|
| 5/99 GMT Mo 1 |
81
|
64
|
66
|
72
|
57
|
76
|
71
|
2.56
|
| 5/99 GMT Mo 2 |
40
|
34
|
505
|
451
|
26
|
40
|
481
|
2.48
|
| 5/99 GMT Mo 3 |
25
|
23
|
303
|
273
|
540
|
822
|
584
|
2.58
|
| 5/99 GMT Mo 6 |
12
|
11
|
125
|
113
|
124
|
147
|
186
|
2.03
|
| 5/99 GMT Mo 7 |
880
|
8.61
|
1094
|
99
|
994
|
121
|
164
|
53
|
| NZ98/254 GMT Mo 0 |
2.87
|
3.35
|
3.43
|
2.98
|
3.07
|
3.39
|
2.83
|
3.12
|
| NZ98/254 GMT Mo1 |
42
|
44
|
47
|
45
|
37
|
42
|
49
|
2.85
|
| NZ98/254 GMT Mo 2 |
23
|
25
|
98
|
89
|
19
|
26
|
92
|
3.28
|
| NZ98/254 GMT Mo 3 |
17
|
19
|
61
|
52
|
117
|
125
|
122
|
3.57
|
| NZ98/254 GMT Mo 6 |
12
|
11
|
31
|
29
|
44
|
49
|
52
|
4.17
|
| NZ98/254 GMT Mo 7 |
140
|
10
|
181
|
24
|
168
|
39
|
41
|
47
|
| Title | Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination. |
|---|---|
| Description | Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254. |
| Time Frame | month-1, month-2, month-3, month-6 and month-7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed as per the protocol dataset. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. |
| Measure Participants | 112 | 223 | 113 | 231 | 110 | 232 | 333 | 115 |
| 44/76 GMR Mo 1 to 0 |
13
|
14
|
17
|
16
|
13
|
14
|
15
|
0.89
|
| 44/76 GMR Mo 2 to 0 |
8.92
|
9.65
|
53
|
56
|
8.43
|
9.51
|
50
|
1.04
|
| 44/76 GMR Mo 3 to 0 |
5.98
|
7.31
|
37
|
34
|
55
|
58
|
62
|
0.98
|
| 44/76 GMR Mo 6 to 0 |
3.98
|
3.64
|
17
|
16
|
16
|
20
|
23
|
0.92
|
| 44/76 GMR Mo 7 to 0 |
74
|
3.09
|
92
|
12
|
79
|
13
|
16
|
13
|
| 44/76 GMR Mo 7 to 6 |
18
|
0.89
|
5.36
|
0.72
|
5.08
|
0.67
|
0.67
|
14
|
| 5/99 GMR Mo 1 to 0 |
31
|
20
|
25
|
29
|
23
|
28
|
28
|
1.13
|
| 5/99 GMR Mo 2 to 0 |
15
|
11
|
198
|
181
|
11
|
15
|
186
|
1.06
|
| 5/99 GMR Mo 3 to 0 |
9.22
|
7.37
|
115
|
109
|
233
|
306
|
225
|
1.09
|
| 5/99 GMR Mo 6 to 0 |
4.65
|
3.83
|
49
|
45
|
52
|
56
|
74
|
0.82
|
| 5/99 GMR Mo 7 to 0 |
355
|
3.07
|
430
|
40
|
427
|
46
|
65
|
21
|
| 5/99 GMR Mo 7 to 6 |
71
|
0.83
|
8.98
|
0.87
|
7.92
|
0.83
|
0.86
|
26
|
| NZ98/254 GMR Mo 1 to 0 |
14
|
13
|
14
|
15
|
12
|
12
|
17
|
0.91
|
| NZ98/254 GMR Mo 2 to 0 |
7.69
|
7.24
|
29
|
30
|
6.46
|
7.96
|
33
|
1.06
|
| NZ98/254 GMR Mo 3 to 0 |
6.01
|
5.5
|
18
|
18
|
40
|
38
|
44
|
1.13
|
| NZ98/254 GMR Mo 6 to 0 |
4.75
|
3.49
|
9.26
|
10
|
14
|
15
|
19
|
1.28
|
| NZ98/254 GMR Mo 7 to 0 |
59
|
3.32
|
53
|
8.94
|
57
|
13
|
15
|
15
|
| NZ98/254 GMR Mo 7 to 6 |
11
|
0.99
|
5.86
|
0.85
|
3.95
|
0.84
|
0.81
|
11
|
| Title | GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination. |
|---|---|
| Description | Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen. |
| Time Frame | month-1, month-2, month-3, month-6 and month-7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed as per the protocol dataset. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. |
| Measure Participants | 34 | 35 | 35 | 35 | 35 | 35 | 35 | 35 |
| GMC Mo 0 |
35
|
35
|
43
|
37
|
44
|
32
|
32
|
48
|
| GMC Mo 1 |
190
|
204
|
334
|
217
|
234
|
220
|
521
|
50
|
| GMC Mo 2 |
173
|
154
|
3025
|
3875
|
175
|
144
|
3693
|
42
|
| GMC Mo 3 |
102
|
124
|
1612
|
1831
|
3332
|
2936
|
5314
|
42
|
| GMC Mo 6 |
91
|
72
|
565
|
488
|
807
|
628
|
1602
|
37
|
| GMC Mo 7 |
2240
|
69
|
3840
|
383
|
5492
|
532
|
1111
|
283
|
| Title | GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination |
|---|---|
| Description | Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen |
| Time Frame | month-1, month-2, month-3, month-6 and month-7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed as per the protocol dataset. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. |
| Measure Participants | 34 | 35 | 35 | 35 | 35 | 35 | 35 | 35 |
| GMR Mo 1 to 0 |
5.73
|
5.82
|
7.75
|
5.34
|
5.26
|
6.85
|
16
|
1.03
|
| GMR Mo 2 to 0 |
4.9
|
4.38
|
70
|
112
|
3.94
|
4.46
|
116
|
0.87
|
| GMR Mo 3 to 0 |
2.9
|
3.54
|
37
|
55
|
75
|
91
|
167
|
0.88
|
| GMR Mo 6 to 0 |
2.56
|
2.06
|
13
|
13
|
18
|
20
|
50
|
0.77
|
| GMR Mo 7 to 0 |
63
|
1.94
|
89
|
11
|
123
|
17
|
35
|
5.9
|
| Title | Number of Subjects Reporting Unsolicited AEs Throughout the Study. |
|---|---|
| Description | Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study. |
| Time Frame | Throughout the study |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed as per the safety dataset. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. |
| Measure Participants | 128 | 247 | 128 | 247 | 127 | 253 | 373 | 128 |
| Any AE's |
65
50.8%
|
137
55.5%
|
73
57%
|
143
57.9%
|
72
56.7%
|
148
58.5%
|
210
56.3%
|
80
62.5%
|
| At least possibly related AEs |
22
17.2%
|
36
14.6%
|
30
23.4%
|
36
14.6%
|
24
18.9%
|
43
17%
|
76
20.4%
|
26
20.3%
|
| Serious AEs |
5
3.9%
|
4
1.6%
|
2
1.6%
|
4
1.6%
|
2
1.6%
|
4
1.6%
|
11
2.9%
|
3
2.3%
|
| At least possibly related SAEs |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
0.5%
|
0
0%
|
| AEs leading to discontinuation |
1
0.8%
|
0
0%
|
0
0%
|
0
0%
|
1
0.8%
|
0
0%
|
1
0.3%
|
0
0%
|
| Title | Percentage of Subjects With hSBA Titers≥4 After Receiving Second Dose of Vaccination |
|---|---|
| Description | Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against M10713 strain at 1 month after second dose of vaccination (Month 3) |
| Time Frame | At one month after second dose (Month 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed as per the protocol dataset. Only groups rMenB01 and rMenB02 are applicable to this endpoint as the post-hoc outcome was assessed at an interval of 1 month (rMenB01) or 2 months (rMenB02 ) to kill M10713 strain. |
| Arm/Group Title | rMenB01 | rMenB02 |
|---|---|---|
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. |
| Measure Participants | 46 | 46 |
| Baseline |
96
|
80
|
| 1 month after second dose |
100
|
100
|
Adverse Events
| Time Frame | Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study. | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | ||||||||
| Arm/Group Description | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months. | Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month. | Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months. | Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months. | Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months. | ||||||||
All Cause Mortality |
||||||||||||||||
| rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||
Serious Adverse Events |
||||||||||||||||
| rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/128 (3.9%) | 4/247 (1.6%) | 2/128 (1.6%) | 4/247 (1.6%) | 2/127 (1.6%) | 4/253 (1.6%) | 11/373 (2.9%) | 3/128 (2.3%) | ||||||||
| Infections and infestations | ||||||||||||||||
| APPENDICITIS | 1/128 (0.8%) | 1/247 (0.4%) | 1/128 (0.8%) | 1/247 (0.4%) | 1/127 (0.8%) | 1/253 (0.4%) | 2/373 (0.5%) | 1/128 (0.8%) | ||||||||
| DYSENTERY | 0/128 (0%) | 1/247 (0.4%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| MENINGITIS BACTERlAL | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 1/373 (0.3%) | 0/128 (0%) | ||||||||
| PNEUMONIA VIRAL | 1/128 (0.8%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| SHIGELLAIN FECTION | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 1/253 (0.4%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| JOINT INJURY | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 1/373 (0.3%) | 0/128 (0%) | ||||||||
| LIGAMENT RUPTURE | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 1/373 (0.3%) | 0/128 (0%) | ||||||||
| ROAD TRAFFIC ACCIDENT | 1/128 (0.8%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| TOXICITY TO VARlOUS AGENTS | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 2/253 (0.8%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| JUVENILE IDIOPATHIC ARTHRITIS | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 2/373 (0.5%) | 0/128 (0%) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| ADENOMA BENIGN | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 0/373 (0%) | 1/128 (0.8%) | ||||||||
| BENGIN OVARIAN TUMOUR | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 1/373 (0.3%) | 0/128 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| CONVULSION | 1/128 (0.8%) | 1/247 (0.4%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| EPILEPSY | 0/128 (0%) | 1/247 (0.4%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| SYNCOPE | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 1/373 (0.3%) | 0/128 (0%) | ||||||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||||||
| PREMATURE LABOUR | 1/128 (0.8%) | 0/247 (0%) | 1/128 (0.8%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| Psychiatric disorders | ||||||||||||||||
| MAJOR DEPRESSION | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 1/127 (0.8%) | 0/253 (0%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| PANIC ATTACK | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 1/127 (0.8%) | 0/253 (0%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| SUICIDE ATTEMPT | 0/128 (0%) | 1/247 (0.4%) | 0/128 (0%) | 0/247 (0%) | 1/127 (0.8%) | 0/253 (0%) | 0/373 (0%) | 1/128 (0.8%) | ||||||||
| Renal and urinary disorders | ||||||||||||||||
| GLOMERULONEPHRITIS MINIMAL LESION | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 1/247 (0.4%) | 0/127 (0%) | 0/253 (0%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| Reproductive system and breast disorders | ||||||||||||||||
| TESTICULAR TORSION | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 1/247 (0.4%) | 0/127 (0%) | 0/253 (0%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| ASTHMATIC CRISIS | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 1/373 (0.3%) | 0/128 (0%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| URTICARIA | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 0/247 (0%) | 0/127 (0%) | 0/253 (0%) | 1/373 (0.3%) | 0/128 (0%) | ||||||||
| Surgical and medical procedures | ||||||||||||||||
| ADENOIDECTOMY | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 1/247 (0.4%) | 0/127 (0%) | 0/253 (0%) | 0/373 (0%) | 0/128 (0%) | ||||||||
| TONSILLECTOMY | 0/128 (0%) | 0/247 (0%) | 0/128 (0%) | 1/247 (0.4%) | 0/127 (0%) | 0/253 (0%) | 0/373 (0%) | 0/128 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 123/128 (96.1%) | 238/247 (96.4%) | 126/128 (98.4%) | 242/247 (98%) | 118/127 (92.9%) | 240/253 (94.9%) | 354/373 (94.9%) | 125/128 (97.7%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| NAUSEA | 41/128 (32%) | 80 | 80/247 (32.4%) | 120 | 51/128 (39.8%) | 109 | 72/247 (29.1%) | 126 | 42/127 (33.1%) | 72 | 89/253 (35.2%) | 156 | 143/373 (38.3%) | 276 | 49/128 (38.3%) | 90 |
| General disorders | ||||||||||||||||
| INJECTION SITE ERYTHEMA | 93/128 (72.7%) | 211 | 162/247 (65.6%) | 338 | 97/128 (75.8%) | 225 | 188/247 (76.1%) | 428 | 94/127 (74%) | 251 | 172/253 (68%) | 389 | 282/373 (75.6%) | 680 | 86/128 (67.2%) | 169 |
| INJECTION SITE INDURATION | 72/128 (56.3%) | 149 | 130/247 (52.6%) | 240 | 76/128 (59.4%) | 167 | 151/247 (61.1%) | 328 | 82/127 (64.6%) | 191 | 122/253 (48.2%) | 234 | 228/373 (61.1%) | 564 | 58/128 (45.3%) | 116 |
| INJECTION SITE PAIN | 122/128 (95.3%) | 378 | 236/247 (95.5%) | 667 | 124/128 (96.9%) | 396 | 237/247 (96%) | 729 | 113/127 (89%) | 398 | 236/253 (93.3%) | 749 | 345/373 (92.5%) | 1160 | 123/128 (96.1%) | 398 |
| INJECTION SITE SWELLING | 73/128 (57%) | 129 | 132/247 (53.4%) | 244 | 81/128 (63.3%) | 172 | 144/247 (58.3%) | 310 | 76/127 (59.8%) | 171 | 115/253 (45.5%) | 242 | 226/373 (60.6%) | 523 | 55/128 (43%) | 92 |
| MALAISE | 92/128 (71.9%) | 222 | 181/247 (73.3%) | 371 | 96/128 (75%) | 238 | 172/247 (69.6%) | 405 | 87/127 (68.5%) | 235 | 185/253 (73.1%) | 444 | 272/373 (72.9%) | 690 | 89/128 (69.5%) | 205 |
| PYREXIA | 12/128 (9.4%) | 17 | 8/247 (3.2%) | 11 | 13/128 (10.2%) | 18 | 21/247 (8.5%) | 22 | 18/127 (14.2%) | 20 | 26/253 (10.3%) | 30 | 38/373 (10.2%) | 50 | 20/128 (15.6%) | 27 |
| Infections and infestations | ||||||||||||||||
| BRONCHITIS | 6/128 (4.7%) | 6 | 7/247 (2.8%) | 7 | 5/128 (3.9%) | 5 | 10/247 (4%) | 10 | 9/127 (7.1%) | 9 | 6/253 (2.4%) | 6 | 14/373 (3.8%) | 14 | 11/128 (8.6%) | 14 |
| GASTROENTERITIS | 4/128 (3.1%) | 4 | 7/247 (2.8%) | 8 | 2/128 (1.6%) | 2 | 15/247 (6.1%) | 15 | 2/127 (1.6%) | 2 | 14/253 (5.5%) | 15 | 23/373 (6.2%) | 27 | 3/128 (2.3%) | 3 |
| NASOPHARYNGITIS | 9/128 (7%) | 9 | 24/247 (9.7%) | 26 | 18/128 (14.1%) | 18 | 20/247 (8.1%) | 21 | 9/127 (7.1%) | 11 | 28/253 (11.1%) | 30 | 43/373 (11.5%) | 46 | 13/128 (10.2%) | 15 |
| PHARYNGITIS | 7/128 (5.5%) | 7 | 11/247 (4.5%) | 11 | 5/128 (3.9%) | 6 | 9/247 (3.6%) | 10 | 4/127 (3.1%) | 4 | 7/253 (2.8%) | 7 | 21/373 (5.6%) | 24 | 8/128 (6.3%) | 9 |
| TONSILLITIS | 3/128 (2.3%) | 4 | 5/247 (2%) | 5 | 4/128 (3.1%) | 5 | 7/247 (2.8%) | 9 | 3/127 (2.4%) | 3 | 6/253 (2.4%) | 7 | 16/373 (4.3%) | 18 | 7/128 (5.5%) | 8 |
| Injury, poisoning and procedural complications | ||||||||||||||||
| LIGAMENT SPRAIN | 4/128 (3.1%) | 4 | 6/247 (2.4%) | 6 | 3/128 (2.3%) | 3 | 7/247 (2.8%) | 8 | 7/127 (5.5%) | 7 | 7/253 (2.8%) | 7 | 15/373 (4%) | 15 | 4/128 (3.1%) | 4 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| ARTHRALGIA | 56/128 (43.8%) | 101 | 76/247 (30.8%) | 131 | 55/128 (43%) | 106 | 81/247 (32.8%) | 175 | 39/127 (30.7%) | 81 | 105/253 (41.5%) | 215 | 146/373 (39.1%) | 320 | 44/128 (34.4%) | 77 |
| MYALGIA | 85/128 (66.4%) | 170 | 141/247 (57.1%) | 266 | 91/128 (71.1%) | 187 | 158/247 (64%) | 335 | 82/127 (64.6%) | 193 | 160/253 (63.2%) | 357 | 238/373 (63.8%) | 568 | 91/128 (71.1%) | 198 |
| Nervous system disorders | ||||||||||||||||
| HEADACHE | 79/128 (61.7%) | 185 | 140/247 (56.7%) | 346 | 88/128 (68.8%) | 256 | 160/247 (64.8%) | 444 | 74/127 (58.3%) | 208 | 165/253 (65.2%) | 452 | 244/373 (65.4%) | 704 | 76/128 (59.4%) | 209 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title | Posting Director |
|---|---|
| Organization | Novartis Vaccines |
| Phone | |
| RegistryContactVaccinesUS@novartis.com |
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00661713
Other Study ID Numbers:
- V72P10
First Posted:
Apr 18, 2008
Last Update Posted:
Mar 20, 2019
Last Verified:
Mar 1, 2019