drugset / Trial / NCT01478347

A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults

NCT01478347 ↗

Phase 3 Completed 18 enrolled Novartis Vaccines Novartis · collab
Non-randomizedSingle-groupOpen-labelPrevention

Summary

The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers). In the second part of the study additional blood samples of high responding vaccinated subjects will be collected for the purpose of generating a control serum panel for the human serum bactericidal assay (hSBA) tests.

Timeline

Start
2013-05
Primary completion
2014-03
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant meningococcal B + OMV NZ Unknown — —