Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
A/H5N1 · 2 trials · 1 indication
Seroconversion is defined as either 1) baseline HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40. FDA/EMEA criterion for seroconversion was to meet or exceed 40%. FDA/EMEA criterion for seroprotection was to meet or exceed 70%.
| Arm | Type | Description |
|---|---|---|
| Group 1: 30 µg HA, no LT patch | EXPERIMENTAL | A/H5N1 Vaccine 30 µg HA i.m. on Day 0 |
| Group 2: 30 µg HA + 50 µg LT patch | EXPERIMENTAL | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 |
| Group 3: 30 µg HA + 100 µg LT patch | EXPERIMENTAL | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 |
| Group 4: 45 µg HA, no LT patch | EXPERIMENTAL | A/H5N1 Vaccine 45 µg HA i.m. on Day 0 |
| Group 5: 45 µg HA + 50 µg LT patch | EXPERIMENTAL | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 |
| Group 6: 45 µg HA + 100 µg LT patch | EXPERIMENTAL | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 |
| Group 1 | EXPERIMENTAL | - |
| Group 2 | EXPERIMENTAL | - |
| Group 3 | EXPERIMENTAL | - |
| Group 4 | EXPERIMENTAL | - |
| Group 5 | EXPERIMENTAL | - |
| Group 6 | EXPERIMENTAL | - |
| Group 7 | EXPERIMENTAL | - |
| Group 8 | EXPERIMENTAL | - |
| Group 9 | EXPERIMENTAL | - |
| Group 10 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| A/H5N1 | BIOLOGICAL | A/H5N1 Low Dose |
| LT Adjuvant Patch | BIOLOGICAL | LT Adjuvant Patch Low Dose |
| Placebo | BIOLOGICAL | Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21 |
Inclusion Criteria: * Healthy adult male or females 18 to 49 years of age (inclusive) * Signed Informed Consent * Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours of vaccination with understanding (through in...
A/H5N1 is an investigational vaccine being developed for pandemic influenza. It is intended for use in healthy adults to protect against the H5N1 influenza strain. The vaccine is currently in clinical development and has not been approved by the FDA.
A/H5N1 is being developed by Valneva SE, a biopharmaceutical company traded on the stock exchange under the ticker VALN. Valneva is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy adult populations.
A/H5N1 is in Phase 2 clinical development. It has completed two clinical trials, including a Phase 1 dose-ranging study and a Phase 2 dose-ranging study. The vaccine has received Fast Track designation from the FDA, indicating it is being developed for a serious condition with unmet medical need.
A/H5N1 has completed two clinical trials: NCT00532792, a Phase 1 dose-ranging study with an adjuvant patch enrolling 501 participants, and NCT00908687, a Phase 2 dose-ranging study enrolling 500 participants. Both trials were conducted in the United States and involved healthy adults aged 18 years and older.
A/H5N1 is a specific vaccine candidate targeting the H5N1 influenza strain, which has pandemic potential. It is being studied for use in healthy adults to prevent pandemic influenza. The vaccine is administered with an adjuvant patch to enhance immune response, as evaluated in clinical trials.