At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 196 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.
Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial
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 196 participants.
Detailed Summary
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 methadone maintenance treatment patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B Vaccine
Countries--
CollaboratorsCenters for Disease Control and Prevention, China
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
Primary CompletionJul 2015
First PostedDec 2016
Study CompletionMay 2018
TodayJul 2026
First PostedDec 13, 2016
Enrollment StartOct 1, 2014
Primary CompletionJul 1, 2015
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 9 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