drugset

drugset / Trial / NCT01086904

Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients

NCT01086904 ↗

Phase 2 Completed 122 enrolled French National Institute of Health and Medical Research MCM Vaccines B.V. · collab

NaSingle-groupPrevention

Summary

The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted Influenza A (H1N1) vaccine in renal transplant recipients.

Timeline

Start: 2009-11
Primary completion: 2010-01
Completion: 2010-05

Publications

Results Le Corre N, Thibault F, Pouteil Noble C, Meiffredy V, Daoud S, Cahen R, Charreau I, Bottigioli D, Dollinger C, Aboulker JP, Autran B, Morelon E, Barrou B. Effect of two injections of non-adjuvanted influenza A H1N1pdm2009 vaccine in renal transplant recipients: INSERM C09-32 TRANSFLUVAC trial. Vaccine. 2012 Dec 14;30(52):7522-8. doi: 10.1016/j.vaccine.2012.10.047. Epub 2012 Oct 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	inactivated non adjuvanted pandemic H1N1 vaccine	Vaccine	15 ug	Subcutaneous

Indications