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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00309647 | Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of Age | PHASE1 | COMPLETED | 400 | — | — | Mar 29, 2006 | Nov 16, 2006 | May 8, 2017 | 9 | Germany |
Geometric mean titers (GMTs) of serum antibodies
| Arm | Type | Description |
|---|---|---|
| H5N1 Formulation 1 Group | EXPERIMENTAL | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval |
| H5N1 Formulation 2 Group | EXPERIMENTAL | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval |
| H5N1 Formulation 3 Group | EXPERIMENTAL | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval |
| H5N1 Formulation 4 Group | EXPERIMENTAL | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval |
| H5N1 Formulation 5 Group | ACTIVE_COMPARATOR | Subjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval |
| H5N1 Formulation 6 Group | ACTIVE_COMPARATOR | Subjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval |
| H5N1 Formulation 7 Group | ACTIVE_COMPARATOR | Subjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval |
| H5N1 Formulation 8 Group | ACTIVE_COMPARATOR | Subjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval |
| Name | Type | Description |
|---|---|---|
| Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine | BIOLOGICAL | 2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21 |
| Influenza Monovalent Whole virus (H5N1) | BIOLOGICAL | 2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21 |
Inclusion criteria: * A male or female between, and including, 18 and 60 years of age at the time of the first vaccination. * Healthy subjects as established by medical history and clinical examination before entering into the study. * If the subject is female, she must be of non-childbearing poten...