Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as cTIV
cTIV+PV OR eTIV_a+PV · 1 trial · 1 indication
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...
cTIV+PV is a trivalent subunit influenza vaccine candidate developed for seasonal influenza immunization. It is produced in mammalian cell culture and uses the strain composition from the 2007/2008 influenza season. The vaccine is designed for use in adults, with clinical testing conducted in healthy volunteers aged 18 years and older.
cTIV+PV is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis conducted the clinical program for this cell-culture-derived trivalent influenza vaccine candidate.
cTIV+PV has been evaluated in Phase 3 clinical development. The vaccine candidate is investigational and has not been approved by the FDA. Its Phase 3 trial has been completed, and no active trials are currently listed for this asset.
cTIV+PV was studied in one completed Phase 3 trial, NCT00511914, titled Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008. The trial enrolled 135 participants in Germany, included healthy volunteers aged 18 years and older of all sexes, and used a controlled design.
Yes, cTIV+PV is also known as cTIV. Both names refer to the same trivalent subunit influenza vaccine candidate produced in mammalian cell culture and developed by Novartis AG for seasonal influenza.