NCT01008813View on ClinicalTrials.gov

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)

PHASE2CompletedINTERVENTIONAL
Enrollment

306

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

February 28, 2010

Study Completion Date

December 31, 2010

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)

Trial Locations (6)

59208

Hôpital Gustave Dron, Service Maladies Infectieuses, Tourcoing

75010

Hôpital Saint-Louis, Paris

75020

Service des Maladies Infectieuses et Tropicales, Hopital Tenon, Paris

75679

CIC de Vaccinologie Cochin Pasteur, hôpital Cochin, Paris

94010

Hôpital Henri Mondor, Créteil

94275

Hopital du Kremlin Bicêtre Service de médecine interne, Kremlin Bicëtre

Sponsors

Collaborators (1)

GlaxoSmithKline
All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

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) | Biotech Hunter | Biotech Hunter