NCT00993447

Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America

Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Years – 16 Years
• Healthy volunteers: Accepted

Summary

Primary objectives: * To describe the immune response to each dengue serotype before and after each vaccination with sanofi pasteur's CYD dengue vaccine. * To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.

Detailed description

The antibody levels against each serotype will be measured before and after each vaccination. The subjects will be followed for 28 days after each vaccination for solicited and unsolicited safety parameters. Serious adverse events (SAEs) will be collected throughout the study.

Conditions

• Dengue
• Dengue Hemorrhagic Fever
• Dengue Virus
• Dengue Fever

Interventions

Type	Name	Description
BIOLOGICAL	CYD Dengue Vaccine	0.5 mL, Subcutaneous at Day 0, 6 and 12 months
BIOLOGICAL	Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis	NaCl: 0.5 mL, Intramuscular at Day 0 and 6 months; Adacel®: 0.5 mL, Intramuscular at 12 months

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-09-01
• Completion: 2012-03-01
• First posted: 2009-10-12
• Last updated: 2022-03-24
• Results posted: 2016-11-29

Locations

4 sites across 4 countries: Colombia, Honduras, Mexico, Puerto Rico