Safety and Immunogenicity of Various Formulations of Live Attenuated Tetravalent Dengue Vaccine in Healthy US Adults

PHASE2CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

April 5, 2006

Primary Completion Date

June 20, 2007

Study Completion Date

March 13, 2008

Conditions
Dengue
Interventions
BIOLOGICAL

Pre-transfection F17

Dengue tetravalent Vaccine F17 Pre transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection

BIOLOGICAL

Post-transfection F17

Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.

BIOLOGICAL

Post-transfection F19

Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.

OTHER

Placebo

Sterile solution of buffered water (0.9% NaCl), U.S. FDA accepted vaccine excipient, phenol red dye(phenolsulfonphthalein, used in vaccines as a pH indicator); 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection

Trial Locations (1)

20910

Walter Reed Army Institute of Research, Silver Spring

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

lead

U.S. Army Medical Research and Development Command

FED