drugset / Trial / NCT01478347
A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant meningococcal B + OMV NZ | Unknown | — | — |