Meningococcal Disease, Invasive Clinical Trial
Official title:
A Randomized, Controlled Trial to Compare Protection in Adolescents Between Different Meningococcal Immunization Schedules Used in Canada; a Canadian Immunization Research Network (CIRN) Study.
| Verified date | March 2022 |
| Source | Canadian Immunization Research Network |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 244 |
| Est. completion date | August 1, 2021 |
| Est. primary completion date | August 1, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 11 Years to 15 Years |
| Eligibility | INCLUSION CRITERIA All the following need to be fulfilled: 1. Healthy adolescent 2. Previous receipt of appropriate MenC vaccine according to the relevant provincial schedule (see above) 3. Parent/legal guardian has given informed consent OR participant has given consent (if participant demonstrates capacity to consent) 4. Participant has given consent (as above) OR assent. EXCLUSION CRITERIA The participant may not enter the trial if ANY of the following apply: 1. Has already received any doses of MenACWY vaccine at any age 2. Previous confirmed or suspected meningococcal disease 3. Close contact with an individual with laboratory-confirmed N. meningitidis in prior 12 months 4. Previous allergic reaction to a component of any of the 3 vaccines 5. Serious chronic or progressive disease 6. Confirmed/suspected immunodeficiency 7. Receipt of more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone >0.5mL/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed 8. Administration of immunoglobulins within the prior 12 months and/or any blood products planned during the study period 9. Pregnancy (based on history from adolescent and parent/legal guardian) 10. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Children's Hospital Research Institute, University of Calgary | Calgary | Alberta |
| Canada | Canadian Center for Vaccinology | Halifax | Nova Scotia |
| Canada | Vaccine Evaluation Center, BC Children's Hospital Research Institute | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Canadian Immunization Research Network | Alberta Health Services, British Columbia Centre for Disease Control, Canadian Center for Vaccinology, Canadian Institutes of Health Research (CIHR), Dalhousie University, University of British Columbia, University of Calgary |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with different MenACWY vaccines | N. meningitidis capsular group C serum bactericidal antibody titer | 1 month following MenACWY booster | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Confirm safety of MenACWY conjugate vaccines | Adverse events as reported by study participants | Up to 1 month post-vaccine |