NCT02491541

A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects

A Single-centre, Randomized, Double-blind, Parallel Control, Phase 3 Study to Evaluate the Safety and Immunogenicity of a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects Aged 10-60 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1) vaccination.

Detailed description

There will be two immunization arms. 1200 healthy subjects will be randomly assigned (1:1) to receive an experimental vaccine or a parallel comparator vaccine. All of them will be received five doses of rabies vaccine at day 0,3,7,14,28 according to the traditional Essen methods (1-1-1-1-1) vaccination.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Changchun Werersai	A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd. 1.0 ml experimental vaccine on day 0,3,7,14,28
BIOLOGICAL	Jilin Maifeng	A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd. 1.0 ml comparator vaccine on day 0,3,7,14,28

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-12-01
• Completion: 2013-12-01
• First posted: 2015-07-08
• Last updated: 2015-07-09

Locations

1 site across 1 country: China