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Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose

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Disease Information

Descriptive Information
Brief Title † Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose
Official Title † Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose
Brief Summary This study is to investigate the persistence of rabies Chinese manufactured antibody 1-5 years after the post-exposure prophylaxis with vero cell antirabies vaccine and antibody response to a single booster dose. A total of 160 subjects would be enrolled. These subjects were all administered ChengDa antirabies vaccine from 2005 to 2009. After informed consent is obtained, these subjects would be tested for their antirabies antibody titer and given a single booster dose. Seven and 14 days later, the investigators would re-evaluate the antibody titer.
Detailed Description
Study Phase Phase 4
Study Type † Interventional
Study Design † Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Primary Outcome Measure † Rabies antibody titer
Secondary Outcome Measure †
Condition † Rabies
Intervention † BiologicalRabies vaccine, manufactured by ChengDa
Study Arms / Comparison Groups Post vaccination All the subjects had been vaccinated with antirabies vaccine.
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 † 160
Start Date † May 2010
Completion Date September 2010
Primary Completion Date August 2010
Eligibility Criteria † Inclusion Criteria: - 20 to 60 years old - Healthy - Given ChengDa rabies vaccine - Good compliance - Obtained informed consent Exclusion Criteria: - Other than inclusion criteria
Gender Both
Ages 20 Years - 60 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † China
Administrative Information
NCT ID † NCT01173302
Organization ID PKUPH-ER-1
Secondary IDs ††
Responsible Party
Study Sponsor † Peking University People's Hospital
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date July 2010
First Received Date † July 19, 2010
Last Updated Date July 30, 2010
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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