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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00819013 | Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults | PHASE1 | COMPLETED | 87 | — | — | Jul 1, 2007 | Feb 1, 2009 | Jan 19, 2012 | 3 | United States |
Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | ACAM-FLU-A low dose + Adjuvant 1 |
| Study Group 2 | EXPERIMENTAL | ACAM-FLU-A low dose + Adjuvant 2 |
| Study Group 3 | EXPERIMENTAL | ACAM-FLU-A low dose |
| Study Group 4 | PLACEBO_COMPARATOR | Saline placebo |
| Name | Type | Description |
|---|---|---|
| Influenza A Vaccine: ACAM FLU-A | BIOLOGICAL | 0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular |
| Saline placebo | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Adult males or females 18 - 40 years of age in good general health Exclusion Criteria: * Known allergies or severe reactions to any of the vaccine components including those to adjuvants * History of severe allergic reactions, including angioedema; * History of asthma or rec...