At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Controlled, Observer-blinded Study To Describe The Immunogenicity, Safety, And Tolerability Of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent Rlp2086) In Healthy Subjects Aged >/= 24 Months To <10 Years
In Brief
A Phase 2 clinical trial evaluating Bivalent rLP2086 Vaccine, Licensed pediatric hepatits A vaccine, and 1 other intervention for MENINGOCOCCAL INFECTION. Completed, enrolled 400 participants across 15 sites in 2 countries.
Detailed Summary
This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young children. The study will also look at the safety of the new vaccine as well as how it is tolerated.
Study Details
Timeline
Interventions
1 dose of 120 μg of bivalent rLP2086 by intramuscular injection at Months 0, 2, and 6 into the upper deltoid muscle of the arm.
1 0.5 mL dose by intramuscular injection at Months 0 and 6 into the upper deltoid muscle of the arm.
Sterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose at Month 2.