At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 239 enrolled
Drug / intervention
rMenB+OMV +2 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 IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Immunocompromised Patients From 2 to 17 Years of Age Who Are at Increased Risk of Meningococcal Disease Because of Complement Deficiency or Asplenia Compared to Matched Healthy Controls.
In Brief
A Phase 3 clinical trial evaluating rMenB+OMV for Meningococcal Disease. Completed, enrolled 239 participants across 20 sites in 5 countries.
Detailed Summary
The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction. A group of healthy age-matched subjects will be enrolled to serve as a descriptive control for immunogenicity and safety.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease
CountriesItaly, Poland, Russia, Spain, United Kingdom
CollaboratorsNovartis Vaccines
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedMay 2014
Primary CompletionMar 2015
TodayJul 2026
First PostedMay 19, 2014
Enrollment StartMay 1, 2014
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.1 years ago
Interventions
rMenB+OMVbiological
2 doses of vaccine 2 months apart
rMenB+OMVbiological
2 doses of vaccine 2 months apart
rMenB+OMVbiological
2 doses of vaccine 2 months apart