MenACWY-CRM
BiologicalBooster vaccination with MenACWY-CRM
Other names: Menveo
NCT Number: NCT03694405
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.
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Notify Me11 year–15 year
All sexes
Interventional
Phase 4
Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Booster vaccination with MenACWY-CRM
Other names: Menveo
Booster vaccination with MenACWY-DT
Other names: Menactra
Booster vaccination with MenACWY-TT
Other names: Nimenrix
Time frame: 1 year following MenACWY adolescent booster
N. meningitidis capsular group C serum bactericidal antibody titer
Time frame: 1 year following MenACWY adolescent booster
N. meningitidis capsular group C serum bactericidal antibody titer
Time frame: 1 month following MenACWY booster
N. meningitidis capsular group C serum bactericidal antibody titer
Time frame: 1 month following MenACWY booster
N. meningitidis capsular group C serum bactericidal antibody titer
Time frame: 1 month and 1 year following MenACWY booster
N. meningitidis capsular group C serum bactericidal antibody titer
Time frame: 1 month and 1 year following MenACWY booster
N. meningitidis capsular group C serum bactericidal antibody titer
Time frame: Up to 1 month post-vaccine
Adverse events as reported by study participants
Canadian Immunization Research Network
Network
A Randomized, Controlled Trial to Compare Protection in Adolescents Between Different Meningococcal Immunization Schedules Used in Canada; a Canadian Immunization Research Network (CIRN) Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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