NCT02305446

Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.

Phase 3b, Open Label, Uncontrolled, Single-arm, Single-centre Study to Evaluate the Safety of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Healthy Adults From 18 to 50 Years of Age and to Collect Blood Donations to Develop Vaccines Against Neisseria Meningitidis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.

Conditions

• Meningitis, Meningococcal, Serogroup B

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (group B) multicomponent recombinant adsorbed vaccine	One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-12-02
• Last updated: 2016-01-05
• Results posted: 2015-11-02

Locations

1 site across 1 country: Poland