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

NCT01031966 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-03-29

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

MF59 adjuvanted H1N1 influenza monovalent vaccine

One/two single administration

DRUG

Thymosin alpha 1

1.6 mg, 3.2 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)

DRUG

Thymosin alpha 1

1.6 mg, 6.4 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)

Sponsors & Collaborators

  • sigma-tau i.f.r. S.p.A.

    lead INDUSTRY

Principal Investigators

  • Agostino Naso, MD · Second Division of Nephrology and Dialysis - Padua Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-05-31
Completion
2010-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01031966 on ClinicalTrials.gov