NCT01365494

Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules

A Phase IV, Multi-center, Randomized, Open-label Study of PCECV (Rabipur®) Comparing the Immunogenicity and Safety of Two Different Simulated Post Exposure Schedules (Zagreb 2-1-1 Versus Essen Regimen 1-1-1-1-1) in Healthy Indian Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study was planned to establish the non-inferiority of Rabipur administered as simulated post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult subjects.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Purified Chick Embryo Cell Inactivated Rabies Vaccine	Two group (Zagreb and Essen) will receive Rabipur vaccine IM according to either Zagreb or Essen schedules.

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-06-03
• Last updated: 2014-05-05
• Results posted: 2014-05-05

Locations

3 sites across 1 country: India