Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years

PHASE2CompletedINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

November 16, 2011

Primary Completion Date

April 1, 2016

Study Completion Date

April 15, 2016

Conditions
Healthy
Interventions
BIOLOGICAL

TDV

TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\*10\^4 PFU, 5\*10\^4 PFU, 1\*10\^5 PFU, and 3\*10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU.

BIOLOGICAL

Placebo

TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).

Trial Locations (8)

716

Ponce School of Medicine, CAIMED Center, Ponce

909

Latin Clinical Trial Center, San Juan

10270

Faculty of Tropical Medicine, Mahidol University, Bangkok

10400

Phramongkutklao Hospital, Bangkok

119228

National University Hospital, Singapore

529889

Changi General Hospital, Singapore

Unknown

Program For The Study and Control of Tropical Diseases, Medellín

00935

University of Puerto Rico School of Medicine, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY