NCT00825305

Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)

A Phase III, Single Center, Randomized, Open-label Study, Comparing PCECV Administered in the Abbreviated Zagreb Regimen (2-1-1) to the Conventional Essen Regimen (1-1-1-1-1) in Healthy Volunteers in China

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 825 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus abbreviated schedule) in healthy adults 18 to 50 years of age in China

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Abbreviated Zagreb 2-1-1 schedule	Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase.
BIOLOGICAL	Standard Essen 1-1-1-1-1 schedule	Subjects received the standard Essen regimen.

Timeline

• Start date: 2008-11-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2009-01-21
• Last updated: 2011-12-13
• Results posted: 2010-05-19

Locations

1 site across 1 country: China