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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00511914 | Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008 | PHASE3 | COMPLETED | 135 | — | — | Jul 1, 2007 | Aug 1, 2007 | Jan 24, 2013 | 2 | Germany |
Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.
Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by hemagglutination inhibition (HI)assay using egg derived antigen in adults and elderly subjects. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22 / Day1) in HI antibody titer is \>2.5 for adults and \>2.0 for elderly subjects.
HI titer as assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects. This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is \>70% for adults and \>60% for elderly subjects.
Proportion of subjects with either seroconversion (antibody increase from \< 10 pre vaccination to ≥40 post vaccination) or significant increase (antibody titer of ≥10 pre vaccination and 4-fold antibody increase post vaccination). According to the CHMP criteria, the percentages of subjects achieving seroconversion or significant increase should be \>40% for adults and \>30% for elderly subjects.
| Arm | Type | Description |
|---|---|---|
| cTIV (Adults) | EXPERIMENTAL | Received one dose of cell-culture derived trivalent influenza vaccine (cTIV). |
| cTIV (Elderly) | EXPERIMENTAL | Received one dose of cell-culture derived trivalent influenza vaccine (cTIV). |
| Name | Type | Description |
|---|---|---|
| cTIV | BIOLOGICAL | One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle |
Inclusion Criteria: Subjects eligible for enrollment into this study are male and female adults who were: 1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry 2. available for all the visits scheduled in the study and able to comply with all stud...