NCT00287469View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

2,000

Participants

Timeline

Start Date

July 9, 2001

Primary Completion Date

January 19, 2004

Study Completion Date

January 31, 2005

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

Trial Locations (1)

Unknown

Shree Birendra Hospital, Kathmandu

Sponsors

Collaborators (1)

GlaxoSmithKline
All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

U.S. Army Medical Research and Development Command

FED