At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 277 enrolled
Drug / intervention
Comparator: modified process hepatitis B vaccine +1 morebiological
Likely dose
Comparator: modified process hepatitis B vaccine 1.0 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process
In Brief
A Phase 3 clinical trial evaluating Comparator: modified process hepatitis B vaccine and Comparator: ENGERIX-B™ for Hepatitis B Virus Infection. Completed, enrolled 277 participants.
Detailed Summary
To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B Virus Infection
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedFeb 2007
Primary CompletionMay 2008
TodayJul 2026
First PostedFeb 27, 2007
Enrollment StartDec 1, 2006
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.3 years ago
Interventions
Comparator: modified process hepatitis B vaccinebiological
Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.
Comparator: ENGERIX-B™biological
ENGERIX-B™ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.