Immunogenicity, Safety and Tolerability of a Trivalent Subunit Inactivated Vaccine in Healthy Subjects 50 Years and Above
Summary
Demonstrate non-inferiority of the post-vaccination (Day 22) Hemagglutination inhibition (HI) Geometric Mean Titers (GMTs) of trivalent, inactivated, subunit influenza vaccine (TIV) over the corresponding GMTs of the comparator vaccine for all three strains, in healthy adults aged 50 years and above. Demonstrate non-inferiority of the percentages of subjects achieving seroconversion in antibody titers at Day 22 in the TIV group over the corresponding percentages of subjects in the comparator group for all three strains, in healthy adults aged 50 years and above.
Timeline
- Start
- 2013-05
- Primary completion
- 2013-12
- Completion
- 2013-12
Outcome
Missed primary endpoint
registry analysis (non-inferiority or equivalence test); Agriflu vs Fluvirin; Ratio of GMTs 1.85 (95% CI 1.66 to 2.06); ANCOVA NCT01867021 ↗
registry analysis (non-inferiority or equivalence test); Agriflu vs Fluvirin; Difference in seroconversion rates 13 (95% CI 10.1 to 16.1); Miettinen and Nurminen NCT01867021 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Agriflu | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Fluvirin | Vaccine | 0.5 ml | Intramuscular |