drugset / Trial / NCT02126761
Safety and Immunogenicity of Different Formulations of an Adjuvanted, Trivalent Subunit Influenza Vaccine in Elderly Subjects 65 Years of Age and Above
RandomizedFactorialQuadruple-blindPrevention
Summary
In this study, the safety and immunogenicity of the current formulation of aTIV will be compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be doubled or tripled and/or the dosage of the 3 influenza virus strains will be doubled, in independently-living elderly subjects ≥ 65 years of age.
Timeline
- Start
- 2014-06
- Primary completion
- 2015-11
- Completion
- 2015-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine | Vaccine | — | — |
| Comparator | Adjuvanted, trivalent subunit influenza vaccine | Vaccine | — | — |
| Subject | Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccine | Vaccine | — | — |
| Subject | Antigen level modified adjuvanted, trivalent subunit influenza vaccine | Vaccine | — | — |