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)
Phase 2
Completed
306 enrolled
French National Agency for Research on AIDS and Viral Hepatitis
GlaxoSmithKline · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FLU D-PAN H1N1 | Vaccine | 3.8 ug | Intramuscular |
| Subject | FLU D-PAN H1N1 | Vaccine | 15 ug | Intramuscular |