NCT00880893

Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore

Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,198 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Primary Objectives: * To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity. * To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period. * To evaluate the humoral immune response to each CYD Dengue serotype after each vaccination in a subset of participants. Secondary Objectives: * To evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.

Detailed description

This was a multicenter trial involving three vaccinations one each at 0, 6 and 12 months over a period of 1 year, and a 4-year follow-up following the last vaccination.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	CYD Dengue vaccine	0.5 mL, Subcutaneous on Day 0, Months 6 and 12
BIOLOGICAL	NaCl + influenza virus or hepatitis A vaccine	0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)

Timeline

• Start date: 2009-04-07
• Primary completion: 2014-10-01
• Completion: 2014-10-14
• First posted: 2009-04-14
• Last updated: 2022-03-21
• Results posted: 2019-07-29

Locations

5 sites across 1 country: Singapore