NCT00875524

Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This trial evaluated the use of a tetravalent vaccine against dengue. Primary objectives: * To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children. * To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age cohorts. * To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with tetravalent dengue vaccine in the 4 age cohorts.

Detailed description

Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.

Conditions

• Dengue Virus
• Dengue Fever
• Dengue Hemorrhagic Fever
• Dengue Disease

Interventions

Type	Name	Description
BIOLOGICAL	CYD dengue vaccine serotypes (1, 2, 3, 4).	0.5 mL, Subcutaneous
BIOLOGICAL	Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide	Each at 0.5 mL, Subcutaneous, respectively

Timeline

• Start date: 2009-03-01
• Primary completion: 2014-08-01
• Completion: 2014-12-01
• First posted: 2009-04-03
• Last updated: 2022-04-05
• Results posted: 2019-07-24

Locations

1 site across 1 country: Vietnam