drugset / Trial / NCT01031966

A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine

NCT01031966

Phase 2 Completed 120 enrolled sigma-tau i.f.r. S.p.A.
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

EvaluationDrugModalityDoseRoute
Comparator Focetria Vaccine
Subject Thymalfasin Peptide 1.6 mg
Subject Thymalfasin Peptide 3.2 mg