NCT00788151

Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years

Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years Previously Vaccinated Against Yellow Fever in Peru

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Accepted

Summary

The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease. Primary Objectives: * To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine. * To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years). * To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).

Detailed description

Participants were randomized to receive either three injections of CYD dengue vaccine or two injections of placebo, and one injection of a pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	CYD Dengue Vaccine Serotypes 1, 2, 3, and 4	0.5 mL, Subcutaneous (SC)
BIOLOGICAL	Pneumococcal polysaccharide vaccine	0.5 mL, SC

Timeline

• Start date: 2008-09-26
• Primary completion: 2010-02-16
• Completion: 2010-08-16
• First posted: 2008-11-10
• Last updated: 2022-04-05
• Results posted: 2019-07-29

Locations

1 site across 1 country: Peru