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

Registry ID

EUCTR2006-003650-20

Source registry

EUCTR

Status

Completed

Phase

PHASE3

Sponsor

Merck & Co Inc.,

Start date

2007-01-31

Completion date

2008-05-05

Last update

2026-08-16

Conditions

• Hepatitis B
• Prophylactic vaccination against infection with hepatitis B virus in renal predialysis and dialysis patients

Summary

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™.

Locations

• , , Spain
• , , Italy
• , , UK

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