CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 19,460 enrolled
Drug / intervention
Hecolin +1 moredrug
Likely dose
Hecolin 0.6mlfrom 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/NCT02759991
NCT02759991Phase 4Completed
CompareCT.gov

An Effectiveness Trial (Phase IV) to Evaluate Protection of Pregnant Women by Hepatitis E Virus (HEV) Vaccine in Bangladesh and Risk Factors for Severe HEV Infection.

Norwegian Institute of Public Health·interventional·Posted May 3, 2016·Updated Aug 15, 2024

In Brief

A Phase 4 clinical trial evaluating Hecolin and Hepa-B for Hepatitis E Infection. Completed, enrolled 19,460 participants across 1 site.

Detailed Summary

The aim of the study is to determine the effectiveness of hepatitis E virus vaccine given in women of child bearing age in preventing HEV disease during pregnancy among women in rural Bangladesh.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis E Infection
CountriesBangladesh
CollaboratorsInternational Centre for Diarrhoeal Disease Research, Bangladesh, Sykehuset Innlandet HF

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 3, 2016
Enrollment StartOct 2, 2017
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.2 years ago

Interventions

Hecolindrug

0.6ml Hecolin vaccine im. on day 0, 1 month and 6 months.

Hepa-Bdrug

1ml Hepa-B vaccine im. on day 0, 1 month and 6 months.