At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 54 enrolled
Drug / intervention
Men ACWY CRM +1 morebiological
Likely dose
Men ACWY CRM 0.5 mLfrom 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 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Age
In Brief
A Phase 2 clinical trial evaluating Men ACWY CRM and 4CMenB for Meningococcal Disease. Completed, enrolled 54 participants across 1 site.
Detailed Summary
This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease
CountriesItaly
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2007
First PostedNov 2007
Primary CompletionNov 2009
TodayJul 2026
First PostedNov 19, 2007
Enrollment StartJul 1, 2007
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.6 years ago
Interventions
Men ACWY CRMbiological
A single dose of a 0.5 mL injectable solution
4CMenBbiological
All subjects received the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.