Meningococcal Disease, Invasive
Conditions
Keywords
MenACWY, Neisseria meningitidis, adolescents
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALMenACWY-CRM
Booster vaccination with MenACWY-CRM
BIOLOGICALMenACWY-DT
Booster vaccination with MenACWY-DT
BIOLOGICALMenACWY-TT
Booster vaccination with MenACWY-TT
Sponsors
University of British Columbia
University of Calgary
Canadian Center for Vaccinology
Alberta Health services
British Columbia Centre for Disease Control
Canadian Institutes of Health Research (CIHR)
Dalhousie University
Canadian Immunization Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between groups with differing priming schedules | 1 year following MenACWY adolescent booster | N. meningitidis capsular group C serum bactericidal antibody titer |
| Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between differing vaccines | 1 year following MenACWY adolescent booster | N. meningitidis capsular group C serum bactericidal antibody titer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirm safety of MenACWY conjugate vaccines | Up to 1 month post-vaccine | Adverse events as reported by study participants |
| 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 | 1 month and 1 year following MenACWY booster | N. meningitidis capsular group C serum bactericidal antibody titer |
| Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with different MenACWY vaccines | 1 month following MenACWY booster | N. meningitidis capsular group C serum bactericidal antibody titer |
| Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with differing MenC priming schedules. | 1 month following MenACWY booster | N. meningitidis capsular group C serum bactericidal antibody titer |
| 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 | 1 month and 1 year following MenACWY booster | N. meningitidis capsular group C serum bactericidal antibody titer |
Countries
Canada
Outcome results
None listed