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| Name | Class |
|---|---|
| University of British Columbia | OTHER |
| University of Calgary | OTHER |
| Canadian Center for Vaccinology | OTHER |
| Alberta Health services |
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This study is to confirm non-inferiority of the three MenACWY vaccines (Menveo, Menactra or Nimenrix) in adolescents, and to identify whether the number of previous doses of MenC influences the response to the MenACWY vaccine.
Participants will be randomized to receive one of the three doses of licensed MenACWY as a booster dose in adolescents. Serology will be collect at 3 time points; prior to the booster dose and 1 month and 1 year post-vaccination to measure antibody levels. The participants are healthy students in grades 7-9 who have not received their MenACWY vaccine yet and received their routine infant MenC vaccines per previous Canadian schedules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1A | Experimental | 3 doses prior MenC , randomized to receive MenACWY-CRM (Menveo) |
|
| Group 1B | Experimental | 3 doses prior MenC, randomized to receive MenACWY-DT (Menactra) |
|
| Group 1C | Experimental | 3 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix) |
|
| Group 2A | Experimental | 2 doses prior MenC, randomized to receive MenACWY-CRM (Menveo) |
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| Group 2B | Experimental | 2 doses prior MenC, randomized to receive MenACWY-DT (Menactra) |
|
| Group 2C | Experimental | 2 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenACWY-CRM | Biological | Booster vaccination with MenACWY-CRM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between groups with differing priming schedules | N. meningitidis capsular group C serum bactericidal antibody titer | 1 year following MenACWY adolescent booster |
| Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between differing vaccines | N. meningitidis capsular group C serum bactericidal antibody titer | 1 year following MenACWY adolescent booster |
| Measure | Description | Time Frame |
|---|---|---|
| Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with differing MenC priming schedules. | N. meningitidis capsular group C serum bactericidal antibody titer | 1 month following MenACWY booster |
| Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with different MenACWY vaccines |
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INCLUSION CRITERIA
All the following need to be fulfilled:
EXCLUSION CRITERIA
The participant may not enter the trial if ANY of the following apply:
TEMPORARY EXCLUSION CRITERIA If the adolescent has a temperature ≥ 38°C, then vaccination (and blood sampling if due to occur at same visit) will be postponed until resolution of fever.
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| Name | Affiliation | Role |
|---|---|---|
| Manish Sadarangani, BM BCh DPhil | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Research Institute, University of Calgary | Calgary | Alberta | Canada | |||
| Vaccine Evaluation Center, BC Children's Hospital Research Institute |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C556088 | MenACWY-CRM vaccine |
| D022401 | Meningococcal Vaccines |
| C576777 | tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| OTHER |
| British Columbia Centre for Disease Control | OTHER_GOV |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Dalhousie University | OTHER |
Group 1 = 3 prior doses of MenC vaccine (Alberta), Group 2 = 2 prior doses of MenC vaccine (British Columbia), Group 3 = 1 prior dose of MenC vaccine (Nova Scotia). Group A = Menveo (MenACWY-CRM), Group B = Menactra (MenACWY-DT), Group C = Nimenrix (MenACWY-TT)
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| Group 3A | Experimental | 1 dose prior MenC, randomized to receive MenACWY-CRM (Menveo) |
|
| Group 3B | Experimental | 1 dose prior MenC, randomized to receive MenACWY-DT (Menactra) |
|
| Group 3C | Experimental | 1 dose prior MenC, randomized to receive MenACWY-TT (Nimenrix) |
|
| MenACWY-DT | Biological | Booster vaccination with MenACWY-DT |
|
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| MenACWY-TT | Biological | Booster vaccination with MenACWY-TT |
|
|
N. meningitidis capsular group C serum bactericidal antibody titer |
| 1 month following MenACWY booster |
| Subgroup analysis to determine effects of different MenACWY vaccines in subjects primed with different MenC schedules at 1 month and 1 year post-MenACWY booster | N. meningitidis capsular group C serum bactericidal antibody titer | 1 month and 1 year following MenACWY booster |
| Subgroup analysis to determine effects of different MenC priming schedules in subjects receiving different MenACWY booster immunizations at 1 month and 1 year post-MenACWY booster | N. meningitidis capsular group C serum bactericidal antibody titer | 1 month and 1 year following MenACWY booster |
| Confirm safety of MenACWY conjugate vaccines | Adverse events as reported by study participants | Up to 1 month post-vaccine |
| Vancouver |
| British Columbia |
| Canada |
| Canadian Center for Vaccinology | Halifax | Nova Scotia | Canada |
| D007239 | Infections |