Phase II Trial to Evaluate Safety and Immunogenicity of a Dengue 1,2,3,4 (Attenuated) Vaccine

PHASE2UnknownINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

April 30, 2016

Study Completion Date

December 31, 2020

Conditions
Dengue
Interventions
BIOLOGICAL

Dengue 1,2,3,4 (attenuated) vaccine

Dose 1000 PFU per virus (1,2,3,4) Route:subcutaneous

BIOLOGICAL

TetraVax-DV Vaccine - Admixture TV003

Dose 1000 PFU per virus (1,2,3,4) Route: subcutaneous

OTHER

Placebo

Route:subcutaneous

Trial Locations (2)

01246- 903

Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo

05403-010

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Banco Nacional de Desenvolvimento Economico e Social

UNKNOWN

collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

collaborator

Butantan Foundation

UNKNOWN

lead

Butantan Institute

OTHER_GOV