A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured with a Modified Process - Hepatitis B Vaccine (Recombinant) Dialysis Study

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2006-003650-20-GB
• Date of registration: 17/12/2006
• Prospective Registration: Yes
• Primary sponsor: Merck & Co Inc.,
• Public title: A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured with a Modified Process - Hepatitis B Vaccine (Recombinant) Dialysis Study
• Scientific title: A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured with a Modified Process - Hepatitis B Vaccine (Recombinant) Dialysis Study
• Date of first enrolment: 19/02/2007
• Target sample size: 276
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003650-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Engerix-B™
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

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.

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 =37.8ºC/=100.0ºF).
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

Health Condition(s) or Problem(s) studied

Hepatitis B
MedDRA version: 8.1 Level: LLT Classification code 10019731 Term: Hepatitis B

Intervention(s)

Product Name: Hepatitis B Vaccine (Recombinant) Modified Process
Pharmaceutical Form: Suspension for injection
Other descriptive name: Hepatitis B Vaccine (Recombinant) Modified Process
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Trade Name: ENGERIX-B
Product Name: Hepatitis B Vaccine (Recombinant)
Pharmaceutical Form: Suspension for injection
Other descriptive name: Hepatitis B vaccine (Recombinant)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Main Objective: Main objective :

1a: 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™.

1b: 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™.

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 BTM

Secondary Objective: Secondary objectives : To describe the safety and tolerability of the modified process hepatitis B vaccine in dialysis and predialysis patients.

Secondary ID(s)

V232-060-02