NCT01187433

Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America

Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Years – 16 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America. Primary Objectives: * To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine. * To evaluate the safety of each vaccination with CYD dengue vaccine.

Detailed description

Participants in the Dengue Vaccine Group will receive 3 vaccinations with CYD Dengue vaccine. Participants in the Control Group will receive placebo vaccinations for the first 2 vaccinations, followed by tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (ADACEL®) (in Venezuela) or Meningococcal A+C vaccine (in Brazil) as a way of providing therapeutic benefit to the participants in the control group.

Conditions

• Dengue
• Dengue Hemorrhagic Fever

Interventions

Type	Name	Description
BIOLOGICAL	Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus	0.5 mL, Subcutaneous (SC)
BIOLOGICAL	NaCl 0.9%	0.5 mL, Subcutaneous
BIOLOGICAL	Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed	0.5 mL, Intramuscular
BIOLOGICAL	Meningococcal A+C vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2010-08-24
• Last updated: 2022-03-21
• Results posted: 2016-11-11

Locations

1 site across 1 country: Brazil