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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016226-13 | EudraCT Number |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adjuvanted A(H1N1)v influenza vaccine | Experimental | Two injections at day 0 and day 21 |
|
| non-adjuvanted A(H1N1)v influenza vaccine | Experimental | Two injection at day 0 and day 21 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjuvanted A(H1N1)v influenza vaccine | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunogenicity and safety of a A(H1N1)v influenza vaccine, administered with or without adjuvant, in HIV-infected patients after two injections. | Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety (local and general adverse events) between the two study vaccines | From week 0 to week 48 | |
| To evaluate the immunogenicity of a A(H1N1)v influenza vaccine, administered with or without adjuvant, in HIV-infected patients receiving antiretroviral therapy or not |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Odile Launay, MD | Centre d'investigation clinique de vaccinologie Cochin-Pasteur, Hôpital Cochin, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor | Créteil | 94010 | France | |||
| Hopital du Kremlin Bicêtre Service de médecine interne |
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| Label | URL |
|---|---|
| legal sponsor's website | View source |
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|
| non-adjuvanted A(H1N1)v influenza vaccine | Biological | Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 [A/California/7/2009 (H1N1)v] (15 microgram) |
|
| Day 21 and Day 42 |
| To describe the factors influencing the response to the vaccine (such as age, sex, tobacco use, HAART, CD4 count and nadir, HIV viral load, ...) | From week 0 to week 48 |
| To compare the sustainability of the immune response induced by two injections of the study | Day 21 and Day 42 |
| To explore the post-vaccinal cellular immune response of the two study vaccines | Day 42 |
| To compare the consequences of the A(H1N1)v influenza vaccine, with or without adjuvant, on the HIV infection parameters (CD4 count, HIV viral load) | Week 48 |
| To assess vaccination failures and describe the clinical presentation of influenza in the study population | Week 48 |
| Kremlin Bicëtre |
| 94275 |
| France |
| Hôpital Saint-Louis | Paris | 75010 | France |
| Service des Maladies Infectieuses et Tropicales, Hopital Tenon | Paris | 75020 | France |
| CIC de Vaccinologie Cochin Pasteur, hôpital Cochin | Paris | 75679 | France |
| Hôpital Gustave Dron, Service Maladies Infectieuses | Tourcoing | 59208 | France |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C556153 | pandemrix |
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