Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of British Columbia | OTHER |
| University of Calgary | OTHER |
| Université de Montréal | OTHER |
| Dalhousie University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The overall aim of this study is to determine if an accelerated "Bexsero® (Multicomponent meningococcal B vaccine)" schedule compared to a standard schedule is immunogenic, safe, and tolerable, in order to increase capacity for rapid outbreak control. In this pilot study no formal hypothesis is tested.
A pilot study to evaluate the feasibility of a rapid clinical trial at the time of a meningococcal B outbreak, comparing an accelerated schedule of 4CMen B (0, 3 weeks) to the 0, 2 months schedule, to determine if the more compressed schedule is immunogenic, safe and tolerable. A shorter schedule offers the potential benefit of more rapid direct and indirect protection, and use of fewer public health resources for implementation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Accelerated Schedule | Active Comparator |
| |
| Group 2: Standard Schedule | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bexsero® | Biological | Multicomponent meningococcal B vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune responses to 4CMenB vaccine, as measured by human Serum Bactericidal Assay (hSBA | Immune responses will be measured:
| Baseline to day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of solicited general adverse events | The number of participants in each vaccine group with each symptom day 0 to 6 after vaccine will be summarized. Each vaccine participant will record if they had any symptoms (yes/no) and the severity (mild, moderate, or severe.) The following general AEs will be solicited:
| Day 0-6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joanne M Langley, MD, MSc, FRCPC | IWK Health Centre, Dalhousie University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31270173 | Derived | Sharkey K, Beernink PT, Langley JM, Gantt S, Quach C, Dold C, Liu Q, Galvan M, Granoff DM. Anti-Factor H Antibody Reactivity in Young Adults Vaccinated with a Meningococcal Serogroup B Vaccine Containing Factor H Binding Protein. mSphere. 2019 Jul 3;4(4):e00393-19. doi: 10.1128/mSphere.00393-19. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C570015 | 4CMenB vaccine |
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
| Havrix® | Biological | Hepatitis A vaccine |
|
| Number of unsolicited general adverse events | The number of participants in each vaccine group with each symptom day 0 to 21 after vaccine will be summarized. Each vaccine participant will record if they had any symptoms (yes/no) and the severity (mild, moderate, or severe.) | Day 0-21 |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 reported in the accelerated vaccine schedule compared to a standard schedule | From injection to Day 180 |
| Number of solicited local and systemic injections site reactions | The following local (injection-site) AEs will be solicited:
| Day 0-6 |
| D045424 |
| Complex Mixtures |