NCT00808028

A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug In Healthy Adolescents Aged 11 To 18 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 538 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.

Conditions

• Meningitis, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	meningococcal B rLP2086 vaccine.	vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
BIOLOGICAL	meningococcal B rLP2086 vaccine.	vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
BIOLOGICAL	meningococcal B rLP2086 vaccine.	vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
OTHER	normal saline (placebo)	vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2008-12-15
• Last updated: 2015-04-14
• Results posted: 2015-04-14

Locations

27 sites across 3 countries: Australia, Poland, Spain