At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
rMenB +1 morebiological
Likely dose
rMenB 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, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, When Administered to Healthy Infants 6-8 Months Old
In Brief
A Phase 2 clinical trial evaluating rMenB and rMenB+OMV for Meningococcal Disease. Completed, enrolled 60 participants across 1 site.
Detailed Summary
To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
First PostedFeb 2007
Primary CompletionDec 2007
Study CompletionJul 2008
TodayJul 2026
First PostedFeb 12, 2007
Enrollment StartFeb 1, 2007
Primary CompletionDec 1, 2007
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.4 years ago
Interventions
rMenBbiological
One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
rMenB+OMVbiological
One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.