NCT01830855

A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,596 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meningococcal Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	rLP2086	0.5 mL dose, given at 0, 2 and 6 months (lot 1)
BIOLOGICAL	rLP2086	0.5 mL dose, given at 0, 2 and 6 months (lot 2)
BIOLOGICAL	rLP2086	0.5 mL dose, given at 0, 2 and 6 months (lot 3)
BIOLOGICAL	Havrix (HAV)	0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.
BIOLOGICAL	Saline	0.5 mL dose of sterile normal saline for injection.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2013-04-12
• Last updated: 2016-06-14
• Results posted: 2016-06-14

Locations

99 sites across 8 countries: United States, Canada, Czechia, Finland, Germany, Italy, Poland, United Kingdom