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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00478816 | Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With Adjuvanted or Non-adjuvanted Influenza Vaccines | PHASE2 | COMPLETED | 58 | — | — | May 1, 2007 | Feb 1, 2009 | Dec 1, 2016 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Group 1 | ACTIVE_COMPARATOR | Primed subject with pandemic Vaccine |
| Group 2 | ACTIVE_COMPARATOR | Non Primed subject with pandemic Vaccine |
| Name | Type | Description |
|---|---|---|
| Fluad H5N1 Pandemic Influenza Vaccine | BIOLOGICAL | Two 0.5 mL doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) hemagglutinin (HA) subvirion influenza vaccine, containing 7.5 μg of H5N1 antigen,administered 3 weeks apart, IM in the deltoid muscle, preferably of the non-dominant arm. |
Inclusion Criteria: 1. Subjects aged 18 to 65 years of age, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol; 2. In good health as determined by: 1. medical history, 2. physical examination, 3. clinical judgmen...