NCT01254422

Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia

Safety and Immunogenicity of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the safety and immunogenicity of Phase III lots of the CYD dengue vaccine in a pediatric population in Malaysia. Primary Objectives: * To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD dengue vaccine in all participants after each injection. * To describe the antibody response to each dengue virus serotype post-injection 2 and post-injection 3.

Detailed description

Healthy participants aged 2 to 11 years received 3 vaccinations at pre-determined schedules and were followed-up for at least 6 months after the last vaccination.

Conditions

• Dengue Fever
• Dengue Hemorrhagic Fever

Interventions

Type	Name	Description
BIOLOGICAL	Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus	0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension
BIOLOGICAL	Placebo: NaCl 0.9%	0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension

Timeline

• Start date: 2010-12-02
• Primary completion: 2012-09-28
• Completion: 2013-01-01
• First posted: 2010-12-06
• Last updated: 2022-03-25
• Results posted: 2019-07-29

Locations

4 sites across 1 country: Malaysia