At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Lot Consistency, Safety, Tolerability, And Immunogenicity Of A Meningococcal Serogroup B Bivalent Rlp2086 Vaccine In Healthy Subjects Aged >/=10 To <19 Years
In Brief
A Phase 3 clinical trial evaluating rLP2086, Havrix (HAV), and 1 other intervention for Meningococcal Vaccine. Completed, enrolled 3,596 participants across 99 sites in 8 countries.
Detailed Summary
This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.
Study Details
Timeline
Interventions
0.5 mL dose, given at 0, 2 and 6 months (lot 1)
0.5 mL dose, given at 0, 2 and 6 months (lot 2)
0.5 mL dose, given at 0, 2 and 6 months (lot 3)
0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.
0.5 mL dose of sterile normal saline for injection.