MedTrace Logo

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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

adjuvanted A(H1N1)v influenza vaccine

Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 \[A/California/7/2009 (H1N1)v\] (3,8 microgram) adjuvanted with AS 03A

BIOLOGICAL

non-adjuvanted A(H1N1)v influenza vaccine

Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 \[A/California/7/2009 (H1N1)v\] (15 microgram)

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Odile Launay, MD · Centre d'investigation clinique de vaccinologie Cochin-Pasteur, Hôpital Cochin, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-02-28
Completion
2010-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01008813 on ClinicalTrials.gov