At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 396 enrolled
Drug / intervention
rLP2086 vaccine +1 morebiological
Likely dose
rLP2086 vaccine 60 mcgfrom 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, RANDOMIZED, CONTROLLED, OBSERVER-BLINDED STUDY CONDUCTED TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A NEISSERIA MENINGITIDIS SEROGROUP B BIVALENT RECOMBINANT LIPOPROTEIN 2086 VACCINE (BIVALENT RLP2086) WHEN ADMINISTERED TO HEALTHY TODDLERS AGED 12 TO <18 MONTHS OR 18 TO <24 MONTHS, AND THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT RLP2086
In Brief
A Phase 2 clinical trial evaluating rLP2086 vaccine and Pediatric HAV vaccine for Meningococcal B Disease. Completed, enrolled 396 participants across 25 sites in 4 countries.
Detailed Summary
The purpose of this study is to investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease. The study will be conducted in healthy toddlers aged between 12 and 24 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal B Disease
CountriesAustralia, Czechia, Finland, Poland
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartAug 2015
Primary CompletionAug 2017
Study CompletionMar 2020
TodayJul 2026
First PostedAug 28, 2015
Enrollment StartAug 31, 2015
Primary CompletionAug 21, 2017
Study CompletionMar 17, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.8 years ago
Interventions
rLP2086 vaccinebiological
60 mcg or 120mcg at 0, 2 and 6 months
Pediatric HAV vaccinebiological
0.5-mL dose at months 0 and 6. Normal saline at month 2.