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 being developed for pandemic influenza, targeting the A/H5N1 influenza virus strain. It is an investigational monoclonal antibody from Valneva SE. The program is in Phase 2 clinical development, with two completed trials in healthy adult volunteers.
A/H5N1 is being developed by Valneva SE, which trades under the ticker VALN. The company is advancing the monoclonal antibody candidate for pandemic influenza. Both clinical trials conducted to date have been completed.
A/H5N1 is in Phase 2 clinical development. The program includes two completed trials: a Phase 2 dose ranging study and a Phase 1 dose ranging study with an adjuvant patch. No trials are currently active.
A/H5N1 has been studied in two completed trials. NCT00908687 was a Phase 2 dose ranging study enrolling 500 healthy adult volunteers in the United States. NCT00532792 was a Phase 1 dose ranging study with an adjuvant patch enrolling 501 participants, also in the United States.