Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose

PHASE3CompletedINTERVENTIONAL
Enrollment

365

Participants

Timeline

Start Date

November 12, 2019

Primary Completion Date

May 25, 2024

Study Completion Date

May 25, 2024

Conditions
Dengue Fever
Interventions
BIOLOGICAL

Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)

TDV subcutaneous injection

BIOLOGICAL

Placebo

Normal Saline (0.9% NaCl) subcutaneous injection

Trial Locations (10)

20850

Optima Research, Rockville

35802

AES - DRS - Optimal Research Alabama - Huntsville, Huntsville

61614

AES - DRS - Optimal Research Illinois - Peoria, Peoria

63141

AES - DRS - Synexus Clinical Research US, Inc. - St. Louis, St Louis

67114

Alliance for Multispecialty Research, LLC - Newton - PPDS, Newton

68046

AES - DRS - Synexus Clinical Research US, Inc. - Omaha, Papillion

55423-2590

AES - DRS - Synexus Clinical Research US, Inc. Minneapolis, Richfield

84088-8865

Advanced Clinical Research/Velocity Clinical Research, West Jordan

04530

Instituto Nacional de Pediatria, Mexico City

06760

CAIMED Investigacion en Salud S.A de C.V., Mexico City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY