A PILOT, RANDOMIZED, SINGLE SITE, 3 PARALLEL ARMS, OPEN-LABEL STUDY IN PATIENTS ON CHRONIC DIALYSIS WITH END STAGE RENAL DISEASE (ESRD) TO EVALUATE THE ENHANCING EFFECT OF TWO DOSES OF THYMOSIN ALPHA 1 ON THE IMMUNOGENICITY OF EGG-DERIVED H1N1sw MONOVALENT INFLUENZA VACCINE - ND

• Conditions: ZADAXIN ENHANCING EFFECT IN PATIENTS ON CHRONIC DIALYSIS WITH END STAGE RENAL DISEASE (ESRD) TREATED WITH EGG-DERIVED H1N1sw MONOVALENT INFLUENZA VACCINE; MedDRA version: 12.1Level: LLTClassification code 10014647Term: End stage renal failure

• Registration Number: EUCTR2009-016362-85-IT
• Lead Sponsor: SIGMA-TA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Signed written informed consent. Age > 18 . Chronic dialysis for ESRD. Life expectancy of at least 6 months. Total bilirubin < 2 mg/dl, and no history of hepatic encephalopathy, bleeding oesophageal varices or ascites. Haematocrit > 30%, platelet count > 75 x 103/mm3, WBC > 2.5 x 103/mm3, total neutrophil granulocytes count > 1.5 x 103/mm3, and haemoglobin > 11 g/dl for women and > 12 g/dl for men. All women of childbearing potential must agree to practice abstinence from sexual intercourses or use of two reliable forms of effective contraception (combined) during the treatment period. Negative pregnancy test prior (no more than 48 hours) to first study medication dose.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

They have any serious disease such as: cancer; autoimmune disease; chronic obstructive pulmonary disease (COPD) that requires oxygen therapy; acute or progressive hepatic disease. They are hypersensitive to eggs, chicken protein, or any other component of the vaccine. They have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine. They have a known or suspected (or have a high risk of developing) impairment/ alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from: receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months; suspected or known HIV infection or HIV-related disease. Women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial. Within the past 4 weeks they have received: another vaccine; any investigational agent. Within the past 3 days, they have experienced fever (i.e., axillary temperature _ 38C). They are taking part in another clinical study. They have surgery planned during the study period. They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified