At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 2,000 enrolled

Drug / intervention

Hepatitis E vaccine, recombinant (Sar 56 kDa) +1 morebiological

Likely dose

Hepatitis E vaccine, recombinant (Sar 56 kDa) 20mcgfrom 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/NCT00287469

NCT00287469Phase 2Completed

Compare CT.gov

A Phase II, Prospective, Randomized, Double-blind, Placebo Controlled, Field Efficacy Trial of a Candidate Hepatitis E Vaccine in Nepal.

U.S. Army Medical Research and Development Command·interventional·Posted Feb 6, 2006·Updated May 29, 2019

In Brief

A Phase 2 clinical trial evaluating Hepatitis E vaccine, recombinant (Sar 56 kDa) and Placebo for Hepatitis. Completed, enrolled 2,000 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if a hepatitis E vaccine is safe and able to prevent symptomatic liver disease due to the hepatitis E virus.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis

CountriesNepal

CollaboratorsGlaxoSmithKline, National Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished

200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2001

Primary CompletionJan 2004

Study CompletionJan 2005

First PostedFeb 2006

TodayJul 2026

First PostedFeb 6, 2006

Enrollment StartJul 9, 2001

Primary CompletionJan 19, 2004

Study CompletionJan 1, 2005

TodayJul 2, 2026

Enrollment to primary: 2.5 yearsPosted 20.4 years ago

Interventions

Hepatitis E vaccine, recombinant (Sar 56 kDa)biological

20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)

Placeboother

PBS buffer placebo containing alum