Adolescent MenACWY Booster Study
- Conditions
- Meningococcal Disease, Invasive
- Interventions
- Biological: MenACWY-DTBiological: MenACWY-TTBiological: MenACWY-CRM
- Registration Number
- NCT03694405
- Lead Sponsor
- Canadian Immunization Research Network
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 244
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2B MenACWY-DT 2 doses prior MenC, randomized to receive MenACWY-DT (Menactra) Group 3B MenACWY-DT 1 dose prior MenC, randomized to receive MenACWY-DT (Menactra) Group 1B MenACWY-DT 3 doses prior MenC, randomized to receive MenACWY-DT (Menactra) Group 3C MenACWY-TT 1 dose prior MenC, randomized to receive MenACWY-TT (Nimenrix) Group 1A MenACWY-CRM 3 doses prior MenC , randomized to receive MenACWY-CRM (Menveo) Group 2C MenACWY-TT 2 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix) Group 1C MenACWY-TT 3 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix) Group 2A MenACWY-CRM 2 doses prior MenC, randomized to receive MenACWY-CRM (Menveo) Group 3A MenACWY-CRM 1 dose prior MenC, randomized to receive MenACWY-CRM (Menveo)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Confirm safety of MenACWY conjugate vaccines Up to 1 month post-vaccine Adverse events as reported by study participants
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
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
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
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
Trial Locations
- Locations (3)
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, Canada