drugset / Trial / NCT00611663

Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus

NCT00611663

RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of this study is to compare the immunological efficacy of two pneumococcal vaccination strategies in patients with systemic lupus erythematosus (SLE) treated with corticosteroids associated or not with other immunosuppressive drugs : 1) a prime-boost strategy using vaccination with conjugate vaccine (Prevenar®) at week 0 and Poly Saccharidic vaccine (Pneumo23®) after 6 months (W24)2) compared to the standard vaccination with Poly Saccharidic vaccine (Pneumo23®) at W24 after placebo at W0

Timeline

Start
2008-05
Primary completion
2014-12
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Prevnar 13 Vaccine
Background Pneumovax 23 Vaccine