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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01342796 | Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects | PHASE2 | COMPLETED | 84 | — | — | May 1, 2011 | Feb 1, 2012 | Apr 19, 2021 | 2 | Belgium |
The CMI responses were determined by intracellular staining/Fluorescence-Activated Cell Sorting(ICS/FACS) after in-vitro restimulation of PBMC with vaccine antigens on day 0 and day 50.
The number of subjects reporting unsolicited AEs between Day 1 and the study termination i.e., Day 50, after receiving two doses of aTIV and TIV. Data are reported based on the Safety Set.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MF59C.1-adjuvanted subunit influenza vaccine | BIOLOGICAL | 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm |
| Sub unit, Inactivated, Influenza vaccine | BIOLOGICAL | 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm |
Inclusion Criteria: * Male and female previously unvaccinated healthy children aged 6 to \<36 months. Exclusion Criteria: * Any known or suspected impairment of the immune system, any serious disease. * Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks ...