CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
rLP2086biological
Likely dose
rLP2086 0.5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01768117
NCT01768117Phase 2Completed

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

Pfizer·interventional·Posted Jan 15, 2013·Updated Dec 20, 2018

In Brief

A Phase 2 clinical trial evaluating rLP2086 for Meningitis, Meningococcal, Serogroup B. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2013
Enrollment StartFeb 1, 2013
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.5 years ago

Interventions

rLP2086biological

0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months