CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,715 enrolled
Drug / intervention
rLP2086 vaccine +1 morebiological
Likely dose
rLP2086 vaccine 120 mcgfrom 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/NCT01352793
NCT01352793Phase 3Completed
CompareCT.gov

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

Pfizer·interventional·Posted May 12, 2011·Updated Mar 11, 2015

In Brief

A Phase 3 clinical trial evaluating rLP2086 vaccine and control for Meningitis, Meningococcal. Completed, enrolled 5,715 participants across 86 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningitis, Meningococcal
CountriesAustralia, Chile, Czechia, Denmark, Estonia, Finland, Germany, Lithuania, Poland, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 12, 2011
Enrollment StartNov 1, 2012
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.1 years ago

Interventions

rLP2086 vaccinebiological

120 mcg, 3 doses, at month 0, 2, and 6.

controlbiological

HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.