Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | PHASE2 | COMPLETED | 306 | — | — | Oct 1, 2009 | Dec 1, 2010 | Apr 7, 2026 | 6 | France |
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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 |
| 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) |
Inclusion Criteria: * Age ≥ 18 years * Able to give written consent * Covered by French Social Security * HIV-infected (infection attested by the patient's chart) * Patients treated by HAART for at least 6 months, with a viral load inferior to 50 copies/mL on at least 2 last visits * Patients witho...