ZADAXIN ENHANCING EFFECT IN PATIENTS ON CHRONIC DIALYSIS WITH END STAGE RENAL DISEASE (ESRD) TREATED WITH EGG-DERIVED H1N1sw MONOVALENT INFLUENZA VACCINE MedDRA version: 12.1 Level: LLT Classification code 10014647 Term: End stage renal failure
Conditions
Interventions
Trade Name: ZADAXIN
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: thymalfasin
CAS Number: 62304-98-7
Current Sponsor code: ST1472
Concentration unit: mg milli
Sponsors
SIGMA-TAU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed written informed consent. Age > 18 . Chronic dialysis for ESRD. Life expectancy of at least 6 months. Total bilirubin 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect preliminary data on the activity of thymosin alpha 1 administered at different doses as enhancer of the egg-derived H1N1sw monovalent vaccine immunogenicity in adults with ESRD on chronic dialysis, based on CHMP criteria.;Secondary Objective: To evaluate the safety and tolerability of Thymosin alpha 1 in combination with H1N1sw monovalent vaccine produced by Novartis and approved by EMEA;Primary end point(s): The immunogenicity criteria for success, as determined by HI, related to the EMEA/CPMP/VEG/4717/2003-Rev.1 (pandemic guideline) and EMEA/CHMP/VWP/263499/2006 (pre-pandemic guideline) are: For adults subjects aged 18-60 years: The percentage of subjects with seroconversion in HI antibody is > 40% The percentage of subjects achieving seroprotection > 70% The GMR is >2.5 For Elderly subject 61 years and over : The percentage of subjects with seroconversion in HI antibody is > 30% The percentage of subjects achieving seroprotection > 60% The GMR is >2.0 All three criteria should be met at Day 21 (after vaccination) within each risk category group to fulfill regulatory requirements. Results collected after Day 21 will also be evaluated against the CHMP criteria as presented above. The number of successes in accordance with these criteria will be computed within each treatment group, together with the percentage of patients who met the criteria for the second vaccination. | — |
Countries
Italy
Outcome results
None listed