drugset / Trial / NCT00611663
Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus
Phase 2/3
Completed
47 enrolled
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prevnar 13 | Vaccine | — | — |
| Background | Pneumovax 23 | Vaccine | — | — |