Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
cTIV · 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 is an investigational seasonal influenza vaccine being developed by Novartis AG. It is intended for use in adults aged 18 years and older to provide protection against seasonal influenza. The vaccine is currently in Phase 3 clinical development, though it remains investigational and has not been approved by regulatory authorities.
cTIV is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and immunogenicity of this seasonal influenza vaccine candidate.
cTIV is in Phase 3 clinical development as a seasonal influenza vaccine. It is an investigational product and has not yet received regulatory approval. The Phase 3 trial has been completed, and the vaccine is not currently in active clinical trials according to available data.
cTIV has one completed Phase 3 clinical trial registered under 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 and evaluated the vaccine's safety and immune response in healthy adults aged 18 years and older.
cTIV is classified as a monoclonal antibody modality, though it is being developed as a seasonal influenza vaccine. The Phase 3 trial assessed its safety and immunogenicity in healthy adults. As an investigational vaccine, it is designed to elicit an immune response against seasonal influenza strains.