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

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Disease Information

Descriptive Information
Brief Title † A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects
Official Title † 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
Brief 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.
Study Phase Phase 3
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary Outcome Measure † Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination
Secondary Outcome Measure † Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 42 days after full vaccination
Condition † Rabies
Intervention † BiologicalChangchun Werersai
Study Arms / Comparison Groups Changchun Werersai A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd. Jilin Maifeng A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 1200
Start Date † August 2012
Completion Date December 2013
Primary Completion Date December 2012
Eligibility Criteria † Inclusion Criteria: - Aged from 10 to 60 years old - Subjects or legal guardians can and will comply with the requirements of the protocol - Subjects or legal guardians are able to understand and sign the informed consent - Healthy subjects judged from medical history after investigator's inquiry - Subjects with temperature
Gender Both
Ages 10 Years - 60 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † China
Administrative Information
NCT ID † NCT02491541
Organization ID 20120002
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Jiangsu Province Centers for Disease Control and Prevention
Collaborators ††
Investigators † Principal Investigator: Yuemei Hu, Jiangsu Provincial Center for Diseases Control and Prevention
Information Provided By
Verification Date July 2015
First Received Date † July 3, 2015
Last Updated Date July 8, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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