NCT01550289

Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India

Immunogenicity and Safety of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects. Primary Objectives: * To describe the neutralizing antibody response to each dengue virus serotype before the first vaccination and after each vaccination with CYD dengue vaccine in all subjects. * To describe the safety of the CYD dengue vaccine after each dose in all subjects. Secondary Objective: * To detect symptomatic dengue cases occurring at any time in the trial.

Detailed description

Participants will receive 3 doses of their randomized treatment (vaccine or placebo). Flavivirus status will be determined at baseline (before the first dose) and the vaccine immunogenicity assessment will be at 28 days after each vaccination. Reactogenicity data will be collected in all subjects after each dose. Serious adverse events and adverse events of special interest will be collected throughout the study.

Conditions

• Dengue
• Dengue Fever
• Dengue Hemorrhagic Fever

Interventions

Type	Name	Description
BIOLOGICAL	Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus	0.5 mL, Subcutaneous
BIOLOGICAL	Placebo: NaCl 0.9% solution	0.5 ml, Subcutaneous

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-12-01
• Completion: 2014-02-01
• First posted: 2012-03-09
• Last updated: 2022-04-05
• Results posted: 2016-11-03

Locations

5 sites across 1 country: India