A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

August 31, 2003

Primary Completion Date

May 31, 2004

Study Completion Date

May 31, 2004

Conditions
Dengue Fever
Interventions
BIOLOGICAL

Dengue Vaccine Formulation 17

Tetravalent live attenuated DEN vaccine candidate. Containing dengue serotypes 1,2, and 3 vaccines produced at the Salk Institute and dengue serotype 4 produced at the WRAIR Pilot Bioproduction Facility. Dosage 1 mL administered via injection at Day 0 and Day 60.

BIOLOGICAL

Licensed Japanese Encephalitis (JE) Vaccine

Produced by the Thailand GPO using a Beijing strain of JE in liquid form; dosed at 0.5 mL ot 7 and 7.5 months.

Trial Locations (1)

10400

Department of Pediatrics, Pharamongkutklao Hospital, Bangkok

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

U.S. Army Medical Research and Development Command

FED