At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 55 enrolled
Drug / intervention
Meningococcal (group B) multicomponent recombinant adsorbed vaccinebiological
Likely dose
Meningococcal (group B) multicomponent recombinant adsorbed vaccine 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.
Phase 3b, Open Label, Uncontrolled, Single-arm, Single-centre Study to Evaluate the Safety of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Healthy Adults From 18 to 50 Years of Age and to Collect Blood Donations to Develop Vaccines Against Neisseria Meningitidis
In Brief
A Phase 3 clinical trial evaluating Meningococcal (group B) multicomponent recombinant adsorbed vaccine for Meningitis, Meningococcal, Serogroup B. Completed, enrolled 55 participants across 1 site.
Detailed Summary
The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningitis, Meningococcal, Serogroup B
CountriesPoland
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedDec 2014
Primary CompletionApr 2015
TodayJul 2026
First PostedDec 2, 2014
Enrollment StartDec 1, 2014
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.6 years ago
Interventions
Meningococcal (group B) multicomponent recombinant adsorbed vaccinebiological
One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.