NCT01224639 - Safety and Immunogenicity Study to Assess TDV, a Live Attenuated Tetravalent Vaccine for Prevention of Dengue Fever | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 11, 2010

Primary Completion Date

June 9, 2011

Study Completion Date

November 9, 2011

Conditions

Dengue Fever

Interventions

BIOLOGICAL

TDV - Low Dose

TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8 x 10\^3 PFU, TDV-2: 5 x 10\^3 PFU, TDV-3: 1 x 10\^4 PFU, and TDV-4: 2 x 10\^5 PFU, total virus per dose 2.2 x 10\^5 PFU

BIOLOGICAL

TDV - High Dose

TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2 x 10\^4 PFU, TDV-2: 5 x 10\^4 PFU, TDV-3: 1 x 10\^5 PFU, and TDV-4: 3 x 10\^5 PFU, total virus per dose : 4.7 x 10\^5 PFU. TDV administered intradermally.

BIOLOGICAL

Placebo

Phosphate Buffered Saline (PBS)

Trial Locations (1)

Unknown

Program For The Study and Control of Tropical Diseases, Medellín