At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,631 enrolled
Drug / intervention
rMenB+OMV NZ +1 morebiological
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 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules
In Brief
A Phase 3 clinical trial evaluating rMenB+OMV NZ and Placebo for Meningococcal Disease. Completed, enrolled 1,631 participants across 10 sites.
Detailed Summary
The proposed study is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease
CountriesChile
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartJun 2008
Primary CompletionApr 2010
Study CompletionDec 2010
TodayJul 2026
First PostedApr 18, 2008
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.2 years ago
Interventions
rMenB+OMV NZbiological
Placebobiological