NCT02531698

A 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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 24 Months – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• MENINGOCOCCAL INFECTION

Interventions

Type	Name	Description
BIOLOGICAL	Bivalent rLP2086 Vaccine	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.
BIOLOGICAL	Licensed pediatric hepatits A vaccine	1 0.5 mL dose by intramuscular injection at Months 0 and 6 into the upper deltoid muscle of the arm.
OTHER	Normal Saline	Sterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose at Month 2.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-08-24
• Last updated: 2020-10-26
• Results posted: 2018-03-27

Locations

15 sites across 2 countries: Finland, Poland