Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

20,099

Participants

Timeline

Start Date

September 7, 2016

Primary Completion Date

July 11, 2018

Study Completion Date

August 12, 2024

Conditions
Healthy Volunteers
Interventions
DRUG

Placebo

TDV placebo-matching SC injection.

BIOLOGICAL

Tetravalent Dengue Vaccine (TDV)

TDV SC injection.

Trial Locations (28)

1000

University of the Philippine Manila, Ermita

1781

Research Institute for Tropical Medicine, City of Muntinlupa

4114

Dela Salle Health Sciences Institute, Dasmariñas

6000

Philippines-AFRIMS Virology Research Unit, Cebu City

10204

Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo

10250

Colombo South Teaching Hospital, Dehiwala

10270

The Hospital for Tropical Diseases, Bangkok

10400

Phramongkutklao Hospital, Bangkok

10514

Calle Alexander Fleming No. 90 Esquina 37, Ensanche La Fe, Santo Domingo

10662

Centro De Vacunacion Internacional, S.A. (Cevaxin), Panama City

11010

Colombo North Teaching Hospital, Ragama

11500

Negombo General Hospital, Negombo

40002

Srinagarind Hospital, Khon Kaen

507001

Centro de Atencion e Investigacion Medica S.A. - CAIMED - Acacias - PPDS-PV, Acacías

29040-091

Universidade Federal Do Espirito Santo Hospital Universitario Cassiano Antonio de Moraes HUCAM, Vitória

40415-000

Associacao Obras Sociais Irma Dulce Hospital Santo Antonio, Salvador

79070-900

Universidade Federal de Mato Grosso do Sul, Campo Grande

59025-050

Centro de Estudos e Pesquisa em Molestias Infecciosas LTDA (CPCLIN), Cidade Alta

Unknown

Centro de Atencion e Investigacion Medica S.A - CAIMED - Aguazul - PPDS-PV, Aguazul

Centro de Atencion e Investigacion Medica S.A - CAIMED - Yopal - PPDS-PV, Yopal

Centro de Estudios em Infectologia Pediatrica SAS (CEIP S.A.S), Santiago de Cali

Universidad Nacional Autonoma de Nicaragua, León

Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede 24 de Diciembre, Panama City

Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede Plaza Carolina, Panama City

Centro De Vacunacion Internacional, S.A.(Cevaxin) - La Chorrera, Panama City

Las Pinas Health Center A, Las Piñas

Las Pinas Health Center D, Las Piñas

00800

Lady Ridgeway Hospital for Children, Colombo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY

NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children | Biotech Hunter | Biotech Hunter