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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2006-003650-20-IT |
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Date of registration:
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15/05/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process - ND
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Scientific title:
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A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process - ND |
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Date of first enrolment:
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26/03/2007 |
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Target sample size:
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276 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003650-20 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Italy
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Male and female predialysis patients (defined as having a creatinine clearance <=30 mL/min as calculated according to the Cockroft-Gault formula) or patients currently receiving either hemodialysis or peritoneal dialysis. 2. Visit 1 (screening visit) blood sample with laboratory confirmed negative result for HBsAg, anti-HBc and anti-HBs. 3. At least 18 years of age. 4. For women, a negative urine pregnancy test just prior to vaccination on visit 2 (day 1)
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:
1. History of previous hepatitis B infection. 2. History of vaccination with any hepatitis B vaccine either alone or in combination. 3. Recent (<72 hours) history of febrile illness (oral temperature >=37.8?C/>=100.0?F). 4. Known or suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (e.g., aluminum, yeast). 5. Recent administration (within 3 months prior to first injection with the study vaccine)of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood derived product or plans to receive such products within the study period. 6. Receipt of licensed inactivated vaccines within 14 days prior to vaccination with the study vaccine. Receipt of licensed live virus vaccines within the 30 days prior to vaccination with the study vaccine or plans to receive licensed vaccines within 30 days following each dose of study vaccine. 7. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine or plans to receive investigational drugs or vaccines within the study period. 8. Known or suspected impairment of immunologic function (other than from renal disease) (e.g., HIV positivity, end-stage liver disease). 9. Recent use (within 3 months prior to first injection with the study vaccine) of systemic immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids. 10. Pregnant women, nursing mothers, and women planning to become pregnant within the study period. 11. Currently abusing IV drugs. 12. Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Prophylactic vaccination against infection with hepatitis B virus in renal predialysis and dialysis patients
MedDRA version: 9.1
Level: LLT
Classification code 10038474
Term: Renal insufficiency
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Intervention(s)
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Product Name: Hepatitis B Vaccine (Recombinant) Modified Process
Pharmaceutical Form: Solution for injection
Current Sponsor code: V232
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: ENGERIX B*IM 25F 1ML 20MCG+SIR
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Hepatitis B, purified antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
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Primary Outcome(s)
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Primary end point(s): The primary purpose of this study is to estimate the SPR (percent of patients with an anti-HBs titer >= 10 mIU/mL) at 1 month after the third and fourth doses for the modified process hepatitis B vaccine and ENGERIX B
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Secondary Objective: - Among dialysis patients and predialysis patients who receive 4 doses of either modified process hepatitis B vaccine or ENGERIX-B, to describe (1 month after the fourth dose of the vaccine) the SPR for the modified process hepatitis B vaccine and ENGERIX-B. - To describe the safety and tolerability of the modified process hepatitis B vaccine in dialysis and predialysis patients.
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Main Objective: Among dialysis patients and predialysis patients who receive 3 doses of either modified process hepatitis B vaccine or ENGERIX-B, to describe (1 month after the third dose of vaccine) the seroprotection rate (SPR) for the modified process hepatitis B vaccine and ENGERIX-B.
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Secondary ID(s)
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2006-003650-20-GB
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V232-060-02
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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