NCT00735644

Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 18 Months
• Healthy volunteers: Accepted

Summary

This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months. Primary objective: To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur. Secondary objective: To describe the safety of vaccination in all subjects

Detailed description

This is a Phase III trial in toddlers in Thailand and the Philippines.

Conditions

• Japanese Encephalitis
• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Japanese encephalitis vaccine	0.5 mL, Subcutaneous
BIOLOGICAL	Japanese encephalitis vaccine	0.5 mL, Subcutaneous
BIOLOGICAL	Japanese encephalitis vaccine	0.5 mL, Subcutaneous
BIOLOGICAL	Japanese encephalitis vaccine (Acambis)	0.5 mL, Subcutaneous
BIOLOGICAL	Hepatitis A vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-05-01
• Completion: 2009-08-01
• First posted: 2008-08-15
• Last updated: 2015-04-21
• Results posted: 2014-08-15

Locations

8 sites across 2 countries: Philippines, Thailand