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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
244
Booster vaccination with MenACWY-CRM
Booster vaccination with MenACWY-DT
Booster vaccination with MenACWY-TT
Children's Hospital Research Institute, University of Calgary
Calgary, Alberta, Canada
Vaccine Evaluation Center, BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada
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
Time frame: 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
Time frame: 1 year following MenACWY adolescent booster
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
Time frame: 1 month following MenACWY booster
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
Time frame: 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
Time frame: 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
Time frame: 1 month and 1 year following MenACWY booster
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Confirm safety of MenACWY conjugate vaccines
Adverse events as reported by study participants
Time frame: Up to 1 month post-vaccine