[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100133629":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":29,"locations":35,"responsibleParty":82,"collaborators":84,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":29,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":29,"enrollmentInfo":97,"targetDuration":29,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":111,"whyStopped":29,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"adjuvanted A(H1N1)v influenza vaccine","EXPERIMENTAL","Two injections at day 0 and day 21",[13],"Biological: adjuvanted A(H1N1)v influenza vaccine",{"label":15,"type":10,"description":16,"interventionNames":17},"non-adjuvanted A(H1N1)v influenza vaccine","Two injection at day 0 and day 21",[18],"Biological: non-adjuvanted A(H1N1)v influenza vaccine",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 \\[A\u002FCalifornia\u002F7\u002F2009 (H1N1)v\\] (3,8 microgram) adjuvanted with AS 03A",[9],[25],"Pandemrix",{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 \\[A\u002FCalifornia\u002F7\u002F2009 (H1N1)v\\] (15 microgram)",[15],null,[31],{"name":32,"affiliation":33,"role":34},"Odile Launay, MD","Centre d'investigation clinique de vaccinologie Cochin-Pasteur, Hôpital Cochin, Paris, France","PRINCIPAL_INVESTIGATOR",[36,48,52,61,67,73],{"facility":37,"status":29,"city":38,"state":29,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":29},"Hôpital Henri Mondor","Créteil","94010","France","FR",{"type":43,"coordinates":44},"Point",[45,46],2.46569,48.79266,{"lat":46,"lon":45},{"facility":49,"status":29,"city":50,"state":29,"zip":51,"country":40,"countryCode":41,"cosmosGeoPoint":29,"geoPoint":29,"contacts":29},"Hopital du Kremlin Bicêtre Service de médecine interne","Kremlin Bicëtre","94275",{"facility":53,"status":29,"city":54,"state":29,"zip":55,"country":40,"countryCode":41,"cosmosGeoPoint":56,"geoPoint":60,"contacts":29},"Hôpital Saint-Louis","Paris","75010",{"type":43,"coordinates":57},[58,59],2.3488,48.85341,{"lat":59,"lon":58},{"facility":62,"status":29,"city":54,"state":29,"zip":63,"country":40,"countryCode":41,"cosmosGeoPoint":64,"geoPoint":66,"contacts":29},"Service des Maladies Infectieuses et Tropicales, Hopital Tenon","75020",{"type":43,"coordinates":65},[58,59],{"lat":59,"lon":58},{"facility":68,"status":29,"city":54,"state":29,"zip":69,"country":40,"countryCode":41,"cosmosGeoPoint":70,"geoPoint":72,"contacts":29},"CIC de Vaccinologie Cochin Pasteur, hôpital Cochin","75679",{"type":43,"coordinates":71},[58,59],{"lat":59,"lon":58},{"facility":74,"status":29,"city":75,"state":29,"zip":76,"country":40,"countryCode":41,"cosmosGeoPoint":77,"geoPoint":81,"contacts":29},"Hôpital Gustave Dron, Service Maladies Infectieuses","Tourcoing","59208",{"type":43,"coordinates":78},[79,80],3.16117,50.72391,{"lat":80,"lon":79},{"type":83,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[85],{"name":86,"class":87},"GlaxoSmithKline","INDUSTRY","100133629","phase-2-clinical-trial-to-evaluate-the-immunogenicity-and-safety-of-an-adjuvanted-ah1n1v-influenza-vaccine-and-a-non-adjuvanted-ah1n1v-influenza-vaccine-in-hiv-infected-patients-anrs-151-hifluvac-100133629",false,"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)","A Randomized Phase II 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)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able to give written consent\n* Covered by French Social Security\n* HIV-infected (infection attested by the patient's chart)\n* Patients treated by HAART for at least 6 months, with a viral load inferior to 50 copies\u002FmL on at least 2 last visits\n* Patients without any treatment for HIV for at least 6 months and without any indication to start a treatment in the following 3 months\n* Patients followed for their HIV-infection in an ANRS center and whose home is close to the center in case of influenza-like illness, consultation and hospitalization in the center where he is followed if necessary\n* For women with childbearing potential, using an effective method of contraception, and willing to undergo urine pregnancy tests prior to each vaccination.\n\nExclusion Criteria:\n\n* Pregnancy\n* Receipt of chemotherapy, immunotherapy (IL2, IL7, IV Ig), or corticosteroids within 3 months prior to enrolment\n* Thrombopenia inferior to 20 000\u002Fmm3\n* Febrile episode (at least 38°C rectal or if at least 37,5°C measured orally) within one week prior to vaccination\n* Opportunistic infection (treated for less than 1 month)\n* Co-infection with HCV and treated with IFNa\n* Influenza (clinically or virologically documented) in the last 6 months\n* History of documented auto-immune disease (lupus, systemic inflammatory disease, ...)\n* Child C cirrhosis\n* Solid organ transplant recipient\n* Intolerance to 1 component of the vaccine\n* Other immunization received within 3 weeks prior to inclusion or planned until after the last vaccine injection.","ALL","18 Years",{"count":98,"type":99},306,"ACTUAL","INTERVENTIONAL",[102],"PHASE2","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.",[105],"HIV Infections",[107,108,109,110],"HIV infection","adjuvanted and non-adjuvanted A(H1N1)v influenza vaccine","immunogenicity","safety","COMPLETED","2026-04-02",{"date":114,"type":99},"2026-04-07",{"date":116,"type":29},"2009-10",{"date":118,"type":99},"2010-12",{"name":120,"class":6},"French National Agency for Research on AIDS and Viral Hepatitis",6]