NCT00621764

Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 5 Years
• Healthy volunteers: Accepted

Summary

Safety: To describe the safety profiles following vaccination. Immunogenicity: To describe the immune response after a single dose of vaccine.

Detailed description

This is a randomized, cross-over, open, active controlled, multi-center trial in toddlers and children in Thailand. Stepwise enrollment of children in 2 age cohorts. Subjects will be followed for 5 years.

Conditions

• Japanese Encephalitis
• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)	≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)
BIOLOGICAL	Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)	0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
BIOLOGICAL	Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)	≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)
BIOLOGICAL	Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)	0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-12-01
• Completion: 2013-05-01
• First posted: 2008-02-22
• Last updated: 2014-10-02
• Results posted: 2014-09-25

Locations

3 sites across 1 country: Thailand