NCT01768117

Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age

A Single-arm, Open-label Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers >=18 To < =65 Years Of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086 vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6 schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program. The study will provide descriptive safety and immunogenicity data following vaccination of these individuals with bivalent rLP2086 vaccine.

Conditions

• Meningitis, Meningococcal, Serogroup B

Interventions

Type	Name	Description
BIOLOGICAL	rLP2086	0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-01-15
• Last updated: 2018-12-20
• Results posted: 2015-03-09

Locations

1 site across 1 country: United States