NCT01352793

A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,715 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Accepted

Summary

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2. All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

Conditions

• Meningitis, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	rLP2086 vaccine	120 mcg, 3 doses, at month 0, 2, and 6.
BIOLOGICAL	control	HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2011-05-12
• Last updated: 2015-03-11
• Results posted: 2015-03-11

Locations

86 sites across 12 countries: United States, Australia, Chile, Czechia, Denmark, Estonia, Finland, Germany, Lithuania, Poland, Spain, Sweden