NCT01064141

A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines

Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the potential for co-administration of the first dose of CYD Dengue vaccine with childhood vaccination. Primary Objectives: * To describe the safety of CYD Dengue vaccine after each dose; first dose given alone or coadministered with childhood vaccines. Secondary Objectives: * To describe the immunogenicity of CYD Dengue vaccine after each dose; first dose given alone or co-administered with childhood vaccines.

Detailed description

Participants will be enrolled in a 3-step enrollment and randomized to 1 of 4 treatment groups. Groups 1 and 2 will receive 5 vaccinations, and Groups 3 and 4 will received 6 vaccinations (childhood vaccines or placebo co-administered with the first dose of CYD Dengue vaccine in 2 separate arms). All toddlers will receive a pentavalent acellular pertussis combination vaccine or Combo (PENTAXIM®), planned approximately 10 months after enrollment.

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, Subcutaneous
BIOLOGICAL	OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines	0.5 mL, Subcutaneous and 0.5 mL, Intravascular
BIOLOGICAL	Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines	0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous
BIOLOGICAL	Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)	0.5 mL Subcutaneous and 0.5 mL Subcutaneous

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-09-01
• Completion: 2012-11-01
• First posted: 2010-02-08
• Last updated: 2013-02-06

Locations

1 site across 1 country: Philippines