E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ZADAXIN ENHANCING EFFECT IN PATIENTS ON CHRONIC DIALYSIS WITH END STAGE RENAL DISEASE (ESRD) TREATED WITH EGG-DERIVED H1N1sw MONOVALENT INFLUENZA VACCINE |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014647 |
E.1.2 | Term | End stage renal failure |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of Thymosin alpha 1 in combination with H1N1sw monovalent vaccine produced by Novartis and approved by EMEA |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Nessun farmaco - same IMP used at different dosage |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |