NCT03694405

Adolescent MenACWY Booster Study

A Randomized, Controlled Trial to Compare Protection in Adolescents Between Different Meningococcal Immunization Schedules Used in Canada; a Canadian Immunization Research Network (CIRN) Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Canadian Immunization Research Network · Network
• Sex: All
• Age: 11 Years – 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meningococcal Disease, Invasive

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM	Booster vaccination with MenACWY-CRM
BIOLOGICAL	MenACWY-DT	Booster vaccination with MenACWY-DT
BIOLOGICAL	MenACWY-TT	Booster vaccination with MenACWY-TT

Timeline

• Start date: 2018-09-20
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2018-10-03
• Last updated: 2022-03-11

Locations

3 sites across 1 country: Canada