NCT01782066

Dose-finding and Safety of 2 Intradermal MEN-ACYW135-conjugate Vaccines

Dose Finding and Reactogenicity of Reduced-dose Intradermal Administration of Two Quadrivalent Meningococcal Conjugate Vaccines (Menveo® and Nimenrix®) in Healthy Adults (MENID-1).

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Invasive meningococcal disease is a worldwide problem with serious repercussions for those affected. Vaccination is recognized as the best way to combat it. The cost of vaccination is prohibitive in many low-resource settings at home and abroad. By harnessing the special immunologic properties of the skin, a dose reduction may be achieved by intradermal administration of the vaccine. The cost savings associated with dose reduction will increase availability of the vaccine.

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	MEN-ACYW135 reduced-dose intradermal administration	Modified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-02-01
• Last updated: 2014-10-29

Locations

1 site across 1 country: Netherlands