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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00841763 | Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects | PHASE3 | COMPLETED | 3,647 | — | — | Oct 1, 2008 | Nov 1, 2009 | Apr 23, 2021 | 2 | Finland, Germany |
To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 pandemic influenza vaccine (aH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 6 days after each vaccination per vaccination group.
To report safety data from a large enough number of subjects exposed to adjuvanted pandemic influenza vaccine aH5N1 capable of detecting rare adverse events (AEs), i.e. events occurring at a frequency of \<=0.1%, \& uncommon AEs in elderly, i.e. occurring at a frequency of \<=1% of subjects.
| Arm | Type | Description |
|---|---|---|
| TIV + aH5N1 | EXPERIMENTAL | First dose of the non-adjuvanted trivalent influenza virus vaccine (TIV) followed by two doses of the adjuvanted monovalent influenza virus vaccine (aH5N1). |
| PL + aTIV | ACTIVE_COMPARATOR | First dose of placebo (PL-saline) followed by two doses of the adjuvanted trivalent influenza virus vaccine (aTIV). |
| Name | Type | Description |
|---|---|---|
| Placebo (PL) | BIOLOGICAL | One dose of 0.5 ml IM injection of isotonic saline solution was administered in the deltoid muscle, preferably of the non-dominant arm. |
| Trivalent influenza virus vaccine (TIV) | BIOLOGICAL | A single IM injection of a 0.5 ml dose of non-adjuvanted trivalent influenza virus vaccine administered in the deltoid muscle, preferably of the non-dominant arm. |
| Adjuvanted monovalent influenza virus vaccine (aH5N1) | BIOLOGICAL | Two intramuscular (IM) injections of a 0.5 ml dose administered three weeks apart in the deltoid muscle. |
| Adjuvanted trivalent influenza virus vaccine (aTIV) | BIOLOGICAL | Two IM injections of a 0.5 ml dose of adjuvanted trivalent influenza virus vaccine administered three weeks apart, in the deltoid muscle. |
Inclusion Criteria: * Subjects 18 years of age and older who were mentally competent and who had signed an informed consent form after having received a detailed explanation of the study protocol; * In good health as determined by: 1. medical history, 2. physical examination, 3. clinical jud...