drugset / Trial / NCT01008813

Clinical Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)

NCT01008813 ↗

RandomizedParallel-groupSingle-blindPrevention

Summary

A 1-year multicenter, randomized, single-blinded, phase II trial, stratified on HAART. The purpose of this trial is to evaluate the immunogenicity and safety of a A(H1N1)French National Agency for Research on AIDS and Viral Hepatitis influenza vaccine, administered with or without adjuvant, in HIV-infected patients after one or two injections.

Timeline

Start
2009-10
Primary completion
2010-02
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject FLU D-PAN H1N1 Vaccine 3.8 ug Intramuscular
Subject FLU D-PAN H1N1 Vaccine 15 ug Intramuscular