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A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.

NCT00287469 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2019-05-29

Study results available
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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.

Conditions

  • Hepatitis

Interventions

BIOLOGICAL

Hepatitis E vaccine, recombinant (Sar 56 kDa)

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

OTHER

Placebo

PBS buffer placebo containing alum

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Mrigendra P Shrestha, MD · Armed Forces Research Institute of Medical Sciences, Thailand

  • Robert M Scott, MD · Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-07-09
Primary Completion
2004-01-19
Completion
2005-01-31
FDA Drug
Yes

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00287469 on ClinicalTrials.gov