NCT02583412

Pilot Study of the Immunogenicity, Reactogenicity and Tolerability of Two Schedules of a 4CmenB Vaccine in Adolescents and Young Adults

Preparedness for and Response to Meningococcal Outbreaks: a Pilot Study of the Immunogenicity, Reactogenicity and Tolerability of Two Schedules of a 4CmenB Vaccine in Adolescents and Young Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Canadian Immunization Research Network · Network
• Sex: All
• Age: 17 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The overall aim of this study is to determine if an accelerated "Bexsero® (Multicomponent meningococcal B vaccine)" schedule compared to a standard schedule is immunogenic, safe, and tolerable, in order to increase capacity for rapid outbreak control. In this pilot study no formal hypothesis is tested.

Detailed description

A pilot study to evaluate the feasibility of a rapid clinical trial at the time of a meningococcal B outbreak, comparing an accelerated schedule of 4CMen B (0, 3 weeks) to the 0, 2 months schedule, to determine if the more compressed schedule is immunogenic, safe and tolerable. A shorter schedule offers the potential benefit of more rapid direct and indirect protection, and use of fewer public health resources for implementation.

Conditions

• Meningococcal Serogroup B

Interventions

Type	Name	Description
BIOLOGICAL	Bexsero®	Multicomponent meningococcal B vaccine
BIOLOGICAL	Havrix®	Hepatitis A vaccine

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2017-06-30
• First posted: 2015-10-22
• Last updated: 2019-01-31

Locations

1 site across 1 country: Canada