Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10
Study Details
Study Description
Brief Summary
This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence at 18 months after the vaccination course in study V72P10 (NCT00661713).
Subjects who participated in study V72P10, and who meet all other enrollment criteria for this extension study, and a group of naïve subjects (defined as subjects who had never received rMenB+OMV NZ or other experimental MenB vaccines) of similar age to the subjects who were eligible to participate in this extension study, performed one study visit in which a single blood sample was drawn for MenB serological analyses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: rMenB06 Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study had a blood draw. |
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Names:
|
| Other: rMenB0 Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study had a blood draw. |
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Names:
|
| Other: rMenB016 Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study had a blood draw. |
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Names:
|
| Other: rMenB01 Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 month) and placebo (at 2 and 6 months) in V72P10 study had a blood draw. |
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Names:
|
| Other: rMenB026 Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study had a blood draw. |
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Names:
|
| Other: rMenB02 Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study had a blood draw. |
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Names:
|
| Other: rMenB012 Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and 1 dose of placebo (at 6 months) in V72P10 study had a blood draw. |
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Names:
|
| Other: rMenB6 Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study had a blood draw. |
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Names:
|
| Other: Naive An additional study group of naïve subjects that served as a baseline comparator for assessing antibody persistence in the vaccine groups and had blood draw for serological analyses at the time of enrollment. |
Biological: No Vaccine
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. [month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.]
The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA).
- Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. [month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.]
The immune response was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.
- Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study. [month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study.]
The immune response was measured as the geometric mean ratio (GMRs) of hSBA GMTs against meningococcal strains 44/76-SL, 5/99 and NZ98/254 as follow: GMTs at 1 month after last vaccination to baseline GMTs; GMTs at 18 months after last vaccination to baselines GMTs; and GMTs at 18 months after last vaccination to GMTs at 1 month after last vaccination.
- Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. [18 months after last vaccination V72P10 study.]
The immune response was measured as the geometric mean concentrations (GMCs) directed against meningococcal 287-953 antigen, evaluated using enzyme-linked immunosorbent assay (ELISA), at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.
Eligibility Criteria
Criteria
Inclusion Criteria:
Informed consent was obtained from all the subjects before enrollment into the study after the nature of the study had been explained.
Inclusion criteria for naive subjects, newly enrolled:
-
Healthy adolescents, 13-19 years of age (the age window is defined as the first day the subject turns 13 years of age up to the day before the subject turns 20 years of age).
-
For Minor subjects:
- subjects who had given their written assent and whose parent or legal guardians had given written informed consent at the time of enrollment, after the nature of the study had been explained.
For Adult subjects:
- subjects who had given their written informed consent at the time of enrollment, after the nature of the study had been explained.
-
Were available for the visit scheduled in the study.
-
Were in good health as determined by medical history, physical examination, clinical judgment of the investigator.
Inclusion criteria for subjects who participated in the V72P10 study (follow-on subjects):
- For Minor subjects: (≤18 years of age)
- subjects who had given their written assent and whose parent or legal guardians had given written informed consent at the time of enrollment, after the nature of the study had been explained.
For Adult subjects: (older than 18 years of age)
- subjects who had given their written informed consent at the time of enrollment, after the nature of the study had been explained.
-
Who had participated in the V72P10 study and had received their last vaccination 18 months (-30 + 90 days) before enrollment in V72P10E1.
-
Who had completed the vaccination course in study V72P10, according to the protocol.
-
Who had provided at least the blood sample one month after the last vaccination in V72P10 (blood sample at visit 6, month 7), according to the protocol.
-
Were available for the study visit scheduled in the study.
-
Were in good health as determined by medical history, physical examination, clinical judgment of the investigator.
Exclusion Criteria:
Exclusion criteria for naïve subjects newly enrolled:
- For Minor subjects:
- subjects who were unwilling or unable to give written informed assent to participate in the study, and whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study
For Adult subjects:
- subjects who were unwilling or unable to give written informed consent to participate in the study.
-
History of any meningococcal B vaccine administration.
-
Previous ascertained or suspected disease caused by N. meningitidis.
-
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.
-
Antibiotic treatment within 6 days prior to enrollment.
-
Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, 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, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to enrollment (use of low or moderate doses of inhaled steroids is not an exclusion);
-
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrollment.
-
Participation in another clinical trial within 90 days prior to enrollment or planned for during study.
-
Family members and household members of study staff.
-
Any condition which, in the opinion of the investigator, could have interfered with the evaluation of the study objectives.
Exclusion criteria for subjects who participated in the V72P10 study (follow-on subjects):
Exclusion criteria were the same as for naïve subjects, with the exception of criterion 2.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centro de Salud Lo Barnechea | Santiago | Chile | ||
| 2 | Centro para vacunas en desarrollo. Hospital de Niños Roberto del Río | Santiago | Chile | ||
| 3 | Escuela de Medicina de la Universidad de Valparaíso | Santiago | Chile | ||
| 4 | Hospital Luis Calvo Mackenna | Santiago | Chile | ||
| 5 | Liceo Jose Victorino Lastarria | Santiago | Chile | ||
| 6 | Universidad de Chile. Facultad de Medicina | 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.- V72P10E1
Study Results
Participant Flow
| Recruitment Details | Subjects were enrolled at six study sites in Chile. |
|---|---|
| Pre-assignment Detail | All enrolled subjects were included in the trial. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | Naive |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects who had received 2 doses each of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB+OMV-NZ) (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study. | Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines |
| Period Title: Overall Study | |||||||||
| STARTED | 49 | 95 | 53 | 102 | 57 | 106 | 153 | 51 | 151 |
| COMPLETED | 49 | 95 | 53 | 102 | 57 | 106 | 153 | 51 | 151 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | Naive | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study. | Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines | Total of all reporting groups |
| Overall Participants | 49 | 95 | 53 | 102 | 57 | 106 | 153 | 51 | 151 | 817 |
| Age (Years) [Mean (Standard Deviation) ] | ||||||||||
| Mean (Standard Deviation) [Years] |
16.2
(1.9)
|
16.0
(2.0)
|
16.2
(2.1)
|
16.1
(1.9)
|
15.6
(1.9)
|
15.9
(1.8)
|
15.9
(1.9)
|
16.0
(1.9)
|
15.6
(1.7)
|
15.9
(1.9)
|
| Sex: Female, Male (Count of Participants) | ||||||||||
| Female |
30
61.2%
|
53
55.8%
|
33
62.3%
|
57
55.9%
|
38
66.7%
|
61
57.5%
|
96
62.7%
|
33
64.7%
|
61
40.4%
|
462
56.5%
|
| Male |
19
38.8%
|
42
44.2%
|
20
37.7%
|
45
44.1%
|
19
33.3%
|
45
42.5%
|
57
37.3%
|
18
35.3%
|
90
59.6%
|
355
43.5%
|
Outcome Measures
| Title | Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. |
|---|---|
| Description | The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA). |
| Time Frame | month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the modified intention-to-treat (MITT) data set, i.e. all subjects who provided evaluable serum samples. Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | Naive |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study. | Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines |
| Measure Participants | 49 | 95 | 53 | 102 | 57 | 106 | 153 | 51 | 151 |
| S.44/76-SL-bl (N=49,95,53,102,57,106,153,51,0) |
31
|
40
|
40
|
32
|
32
|
41
|
44
|
47
|
NA
|
| S.44/76-SL-1m (N=49,95,53,102,57,106,153,51,0) |
100
|
93
|
100
|
100
|
100
|
100
|
100
|
94
|
NA
|
| S.44/76-SL-18m |
84
|
73
|
92
|
82
|
86
|
81
|
83
|
73
|
50
|
| S.5/99-bl (N=49,95,53,102,57,106,153,51,0) |
22
|
33
|
28
|
26
|
21
|
30
|
34
|
33
|
NA
|
| S.5/99-1m (N=49,95,53,102,57,106,153,51,0) |
98
|
96
|
100
|
100
|
100
|
100
|
100
|
88
|
NA
|
| S.5/99-18m |
94
|
65
|
98
|
93
|
100
|
95
|
96
|
73
|
25
|
| S.NZ98/254-bl (N=49,95,53,102,57,106,153,51,0) |
29
|
31
|
32
|
24
|
21
|
30
|
30
|
29
|
NA
|
| S.NZ98/254-1m (N=49,95,53,102,57,106,153,51,0) |
100
|
94
|
100
|
100
|
98
|
100
|
99
|
92
|
NA
|
| S.NZ98/254-18m |
86
|
62
|
98
|
75
|
96
|
75
|
86
|
61
|
40
|
| Title | Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. |
|---|---|
| Description | The immune response was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study. |
| Time Frame | month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the MITT data set.Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | Naive |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study. | Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines |
| Measure Participants | 49 | 95 | 53 | 102 | 57 | 106 | 153 | 51 | 151 |
| S.44/76-SL-bl (N=49,95,53,102,57,106,153,51,0) |
2.83
|
3.75
|
3.56
|
2.74
|
2.76
|
3.24
|
3.86
|
4.33
|
NA
|
| S.44/76-SL-1m (N=49,95,53,102,57,106,153,51,0) |
227
|
47
|
316
|
189
|
265
|
227
|
253
|
62
|
NA
|
| S.44/76-SL-18m |
27
|
16
|
50
|
29
|
44
|
34
|
42
|
19
|
4.52
|
| S.5/99-bl (N=49,95,53,102,57,106,153,51,0) |
2.31
|
2.65
|
2.55
|
2.22
|
1.72
|
2.36
|
2.63
|
2.67
|
NA
|
| S.5/99-1m (N=49,95,53,102,57,106,153,51,0) |
802
|
63
|
1181
|
445
|
1105
|
727
|
605
|
68
|
NA
|
| S.5/99-18m |
65
|
7.1
|
121
|
40
|
100
|
43
|
73
|
9.85
|
2.13
|
| S.NZ98/254-bl (N=49,95,53,102,57,106,153,51,0) |
2.66
|
2.65
|
3.68
|
2.15
|
2.15
|
2.63
|
2.75
|
2.68
|
NA
|
| S.NZ98/254-1m (N=49,95,53,102,57,106,153,51,0) |
154
|
33
|
174
|
78
|
170
|
115
|
129
|
43
|
NA
|
| S.NZ98/254-18m |
27
|
8.71
|
42
|
17
|
41
|
19
|
23
|
9.16
|
3.23
|
| Title | Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study. |
|---|---|
| Description | The immune response was measured as the geometric mean ratio (GMRs) of hSBA GMTs against meningococcal strains 44/76-SL, 5/99 and NZ98/254 as follow: GMTs at 1 month after last vaccination to baseline GMTs; GMTs at 18 months after last vaccination to baselines GMTs; and GMTs at 18 months after last vaccination to GMTs at 1 month after last vaccination. |
| Time Frame | month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the MITT data set. Naive group was not reported for this endpoint since GMR data for this group were not collected (subjects were enrolled in this study and no GMT values at 1m and 18 m after last vaccination in V72P10 are available). |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study. |
| Measure Participants | 49 | 95 | 53 | 102 | 57 | 106 | 153 | 51 |
| S.44/76-SL (1 m postvaccination to baseline) |
80
|
12
|
89
|
69
|
96
|
70
|
66
|
14
|
| S.44/76-SL (18 m postvaccination to baseline) |
9.51
|
4.26
|
14
|
11
|
16
|
11
|
11
|
4.46
|
| S.44/76-SL (18 m to 1 m postvaccination) |
0.12
|
0.34
|
0.16
|
0.15
|
0.17
|
0.15
|
0.16
|
0.31
|
| S.5/99 (1 m postvaccination to baseline) |
347
|
24
|
462
|
200
|
644
|
309
|
230
|
25
|
| S.5/99 (18 m postvaccination to baseline) |
28
|
2.68
|
47
|
18
|
58
|
18
|
28
|
3.69
|
| S.5/99 (18 m to 1 m postvaccination) |
0.081
|
0.11
|
0.1
|
0.091
|
0.09
|
0.06
|
0.12
|
0.15
|
| SNZ98/254 (1 m postvacc to baseline) |
58
|
12
|
47
|
36
|
79
|
44
|
47
|
16
|
| S.NZ98/254 (18 m postvacc to baseline) |
10
|
3.29
|
11
|
7.93
|
19
|
7.37
|
8.42
|
3.43
|
| S.NZ98/254 (18 m to 1 m postvaccination) |
0.17
|
0.27
|
0.24
|
0.22
|
0.24
|
0.17
|
0.18
|
0.21
|
| Title | Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. |
|---|---|
| Description | The immune response was measured as the geometric mean concentrations (GMCs) directed against meningococcal 287-953 antigen, evaluated using enzyme-linked immunosorbent assay (ELISA), at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study. |
| Time Frame | 18 months after last vaccination V72P10 study. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the MITT dataset. |
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | Naive |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study. | Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines |
| Measure Participants | 35 | 34 | 35 | 35 | 35 | 35 | 35 | 34 | 35 |
| Geometric Mean (95% Confidence Interval) [UI/mL] |
272
|
55
|
555
|
217
|
490
|
150
|
175
|
59
|
24
|
Adverse Events
| Time Frame | 18 months after vaccination. | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | There was no vaccine administered in the study. Only safety data related to the blood draw procedure were collected. | |||||||||||||||||
| Arm/Group Title | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | Naive | |||||||||
| Arm/Group Description | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study. | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study. | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study. | Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study. | Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines | |||||||||
All Cause Mortality |
||||||||||||||||||
| rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | Naive | ||||||||||
| 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 | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | Naive | ||||||||||
| 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 | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 0/95 (0%) | 0/53 (0%) | 0/102 (0%) | 0/57 (0%) | 0/106 (0%) | 0/153 (0%) | 0/51 (0%) | 0/151 (0%) | |||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | Naive | ||||||||||
| 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 | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 0/95 (0%) | 0/53 (0%) | 0/102 (0%) | 0/57 (0%) | 0/106 (0%) | 0/153 (0%) | 0/51 (0%) | 0/151 (0%) | |||||||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Posting Director |
|---|---|
| Organization | Novartis Vaccines and Diagnostics |
| Phone | |
| RegistryContactVaccinesUS@novartis.com |
- V72P10E1