At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,507 enrolled
Drug / intervention
Meningococcal B vaccine +7 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 2 Partially Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a New Novartis Meningococcal B Recombinant Vaccine Evaluating the Safety and Immunogenicity When Given Concomitantly With Routine Vaccines in 2-month-old Infants
In Brief
A Phase 2 clinical trial evaluating Meningococcal B vaccine, Control, and 1 other intervention for Meningococcal Meningitis and Meningococcal Infections. Completed, enrolled 1,507 participants across 38 sites in 5 countries.
Detailed Summary
This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Meningitis, Meningococcal Infections
CountriesArgentina, Chile, Czechia, Hungary, Italy
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedJul 2009
Primary CompletionNov 2010
Study CompletionFeb 2012
TodayJul 2026
First PostedJul 13, 2009
Enrollment StartJul 1, 2009
Primary CompletionNov 1, 2010
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.0 years ago
Interventions
Meningococcal B vaccinebiological
Vaccine candidate formulation I
Meningococcal B vaccinebiological
Vaccine candidate formulation II
Meningococcal B vaccinebiological
Vaccine candidate formulation III
Meningococcal B vaccinebiological
Vaccine candidate formulation IV
Meningococcal B vaccinebiological
Vaccine candidate formulation V
Meningococcal B vaccinebiological
Vaccine candidate formulation VI
Controlbiological
Control
Meningococcal B vaccine with antipyreticbiological
Vaccine candidate formulation I with antipyretic