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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).
In the second part of the study additional blood samples of high responding vaccinated subjects will be collected for the purpose of generating a control serum panel for the human serum bactericidal assay (hSBA) tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rMenB+OMV NZ | Experimental | Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant meningococcal B (rMenB) + Outer Membrane Vesicle (OMV NZ) vaccine, 2 months apart, in part I of the study, were enrolled for optional blood draws and safety follow-up in part II of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant meningococcal B + OMV NZ | Biological | 2 injections 2 months apart |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. | The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported. | Day 1 to day 91 |
| Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study). | The number of subjects (who had received two injections of rMenB + OMV NZ vaccine in the part I of this study) reporting unsolicited AEs during the safety follow-up in part II of the study, are reported. Unsolicited AEs in part two of the study include - AEs considered to be related to blood draw procedure and all SAEs. | Day 92 to day 331 |
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Inclusion criteria:
Inclusion criteria for protocol part 2
Exclusion criteria:
Exclusion criteria for protocol part 2:
Known or suspected autoimmune disease;
Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, diabetes, cardiovascular, renal, hepatic, immunological, metabolic, urogenital, hematological, gastrointestinal, central nervous system disease);
Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
History of fainting or seizure episodes;
Pregnancy
Any significant chronic infection;
Significant acute infections within the previous 2 weeks;
Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
Receipt of any chronic immunosuppressive therapy; Receipt of any chronic immunostimulants; Immune deficiency disorder, or known HIV infection;
Significant acute illness within the previous 7 days or body temperature 38.0 C within the previous 3 days;
Receipt of systemic antibiotics within the previous 3 days (72 hours).
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC Medicina Interna 2, Azienda Ospedaliera Universitaria Senese | Siena | 53100 | Italy |
All enrolled subjects participated in the study.
Subjects were recruited from a single center.
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| ID | Title | Description |
|---|---|---|
| FG000 | rMenB+OMV NZ | Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Visit 1-Visit 3 (Day 0-91) - Part I |
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| COMPLETED |
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| NOT COMPLETED |
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| Visit 4-Visit 7 (Day 151-331) - Part II |
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Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures, were administered two injections of rMenB + OMV NZ vaccine, 2 months apart in part I (Visit 1-Visit 3). In part II (Visit 4-Visit 7), subjects were re-enrolled for optional blood draws and safety follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | rMenB+OMV NZ | Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. 18 subjects were enrolled in part I of the study. In part II of the study, subjects were re-enrolled for optional blood draws and safety follow-up. Of the 18 subjects enrolled in part I of the study, only 12 subjects continued participation into protocol part II of the study. Only 11 subjects (one subject was withdrawn after visit 3 due to "lost to follow-up) were included in the safety set and therefore contributed to the baseline characteristics data. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Of the 18 subjects enrolled for part I of the study, only 12 subjects continued participation into protocol part II of the study. Of these, 11 subjects were included in safety set. | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Number | subjects |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. | The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported. | This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part one of the study. | Posted | Number | subjects | Day 1 to day 91 |
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| Primary | Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study). | The number of subjects (who had received two injections of rMenB + OMV NZ vaccine in the part I of this study) reporting unsolicited AEs during the safety follow-up in part II of the study, are reported. Unsolicited AEs in part two of the study include - AEs considered to be related to blood draw procedure and all SAEs. | This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part two of the study. | Posted | Number | subjects | Day 92 to day 331 |
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All serious adverse events and other unsolicited adverse events collected from Day 1 to Day 331 (throughout the study) for subjects who participated in both part I and II of the study, are reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rMenB+OMV NZ | Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up. | 0 | 18 | 2 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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Other disclosure agreement: the terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008585 | Meningitis, Meningococcal |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
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| rMenB( part II; female) |
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| rMenB( part II; male) |
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| Title | Measurements |
|---|---|
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| At least possibly related SAEs |
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| Premature withdrawals due to AEs |
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