At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 475 enrolled
Drug / intervention
Recombinant Hepatitis E Vaccine (Escherichia Coli)biological
Likely dose
Not stated in 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.
An Open, Pared Trial of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® in the Chronic Hepatitis B Patients on the Clinical Stability .( Aged 30 Years or Over)
In Brief
A Phase 4 clinical trial evaluating Recombinant Hepatitis E Vaccine (Escherichia Coli) for Hepatitis E. Completed, enrolled 475 participants across 1 site.
Detailed Summary
This phase IV clinical study was designed to evaluate the immunogenicity and safety of Hecolin® in the chronic Hepatitis B patients on the clinical stability.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis E
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartAug 2016
First PostedNov 2016
Primary CompletionAug 2017
Study CompletionDec 2017
TodayJul 2026
First PostedNov 16, 2016
Enrollment StartAug 1, 2016
Primary CompletionAug 1, 2017
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 9.6 years ago
Interventions
Recombinant Hepatitis E Vaccine (Escherichia Coli)biological
Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.