drugset / Trial / NCT01031966
A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine
RandomizedParallel-groupOpen-labelSupportive care
Summary
The purpose of this explorative trial is to collect preliminary data on efficacy and safety of thymosin alpha 1 given at different doses as an adjuvant to egg-derived H1N1sw monovalent influenza vaccine in hemodialysis patients. The final aim is that of gathering information needed for planning a following confirmatory study on the efficacy and safety of Thymosin alpha 1 in the same indication.
Timeline
- Start
- 2009-11
- Primary completion
- 2010-05
- Completion
- 2010-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | MF59 adjuvanted H1N1 influenza monovalent vaccine | Vaccine | — | — |
| Subject | Thymosin alpha 1 | Peptide | 1.6 mg | — |
| Subject | Thymosin alpha 1 | Peptide | 3.2 mg | — |