CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 352 enrolled
Drug / intervention
60 µg dose hepatitis B vaccine +1 morebiological
Likely dose
60 µg dose hepatitis B vaccinefrom 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.

Search/NCT02963714
NCT02963714Phase 4Completed
CompareCT.gov

Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Hemodialysis Patients in China: a Multicenter Randomized Controlled Trial

Suping Wang·interventional·Posted Nov 15, 2016·Updated Feb 14, 2022

In Brief

A Phase 4 clinical trial evaluating 60 µg dose hepatitis B vaccine and 20 µg dose hepatitis B vaccine for Hepatitis B Vaccine. Completed, enrolled 352 participants.

Detailed Summary

Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge. This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in hemodialysis patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B Vaccine
Countries--
CollaboratorsCenters for Disease Control and Prevention, China

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 15, 2016
Enrollment StartDec 1, 2014
Primary CompletionJul 1, 2015
Study CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.6 years ago

Interventions

60 µg dose hepatitis B vaccinebiological

three-dose, 60 µg per dose

20 µg dose hepatitis B vaccinebiological

three-dose, 20 µg per dose