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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06560151 | Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59 | PHASE2 | COMPLETED | 1,380 | — | — | Aug 21, 2024 | Jun 11, 2025 | Jan 9, 2026 | 20 | United States |
| Arm | Type | Description |
|---|---|---|
| Treatment Group A | EXPERIMENTAL | This treatment group of 60 participants (ages 18-64) in Treatment Group A will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose of AS03A. |
| Treatment Group B | EXPERIMENTAL | This treatment group of 120 participants (60 participants ages 18-64 and 60 participants ages ≥65) in Treatment Group B will receive 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a full dose of AS03A. |
| Treatment Group C | EXPERIMENTAL | This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a full dose of AS03A. |
| Treatment Group D | EXPERIMENTAL | This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a half dose of AS03A. |
| Treatment Group E | EXPERIMENTAL | This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a half dose of AS03A. |
| Treatment Group F | EXPERIMENTAL | This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65 will receive 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a half dose of AS03A. |
| Treatment Group G | EXPERIMENTAL | This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59. |
| Treatment Group H | EXPERIMENTAL | This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59. |
| Treatment Group I | EXPERIMENTAL | This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59. |
| Treatment Group J | EXPERIMENTAL | This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with a full dose of AS03A. |
| Treatment Group K | EXPERIMENTAL | This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with a full dose of AS03A. |
| Treatment Group L | EXPERIMENTAL | This treatment group of 60 participants (ages ≥65) will receive 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with a full dose of AS03A. |
| Treatment Group M | EXPERIMENTAL | This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with MF59. |
| Treatment Group N | EXPERIMENTAL | This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with MF59. |
| Treatment Group O | EXPERIMENTAL | This treatment group of 60 participants (age ≥65) will receive 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with MF59. |
| Name | Type | Description |
|---|---|---|
| 3.75 µg H5N8 antigen plus full dose AS03A | BIOLOGICAL | Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine. |
| 7.5 µg H5N8 antigen plus full dose AS03A | BIOLOGICAL | Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine. |
| 15 µg H5N8 antigen plus full dose AS03A | BIOLOGICAL | Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine. |
| 3.75 µg H5N8 antigen plus half dose AS03A | BIOLOGICAL | Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine. |
| 7.5 µg H5N8 antigen plus half dose AS03A | BIOLOGICAL | Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine. |
| 15 µg H5N8 antigen plus half dose AS03A | BIOLOGICAL | Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine. |
| 3.75 µg H5N8 antigen plus MF59 | BIOLOGICAL | Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine. |
| 7.5 µg H5N8 antigen plus MF59 | BIOLOGICAL | Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine. |
| 15 µg H5N8 antigen plus MF59 | BIOLOGICAL | Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine. |
| 3.75 µg H5N1 antigen plus full dose AS03A | BIOLOGICAL | Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine. |
| 7.5 µg H5N1 antigen plus full dose AS03A | BIOLOGICAL | Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine. |
| 15 µg H5N1 antigen plus full dose AS03A | BIOLOGICAL | Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine. |
| 3.75 µg H5N1 antigen plus MF59 | BIOLOGICAL | Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine. |
| 7.5 µg H5N1 antigen plus MF59 | BIOLOGICAL | Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine. |
| 15 µg H5N1 antigen plus MF59 | BIOLOGICAL | Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine. |
Inclusion Criteria: 1. Male or non-pregnant female, 18 years of age or older at the time of screening and informed consent. 2. Willing and able to provide written informed consent prior to initiation of study procedures. 3. Agrees to have specimens collected during this trial specifically for the p...