At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 18 enrolled
Drug / intervention
Recombinant meningococcal B + OMV NZbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b, Single-Center, Open-label Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-risk Adults
In Brief
A Phase 3 clinical trial evaluating Recombinant meningococcal B + OMV NZ for Meningococcal Disease and Meningococcal Meningitis. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease, Meningococcal Meningitis
CountriesItaly
CollaboratorsNovartis
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartMay 2013
Primary CompletionMar 2014
Study CompletionNov 2014
TodayJul 2026
First PostedNov 23, 2011
Enrollment StartMay 1, 2013
Primary CompletionMar 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.6 years ago
Interventions
Recombinant meningococcal B + OMV NZbiological
2 injections 2 months apart