- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01173302
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
July 30, 2010 updated by: Peking University People's Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100044
- Peking University People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 20 to 60 years old
- Healthy
- Given ChengDa rabies vaccine
- Good compliance
- Obtained informed consent
Exclusion Criteria:
- Other than inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Post vaccination
All the subjects had been vaccinated with antirabies vaccine.
|
1 dose before the antibody is tested
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rabies antibody titer
Time Frame: 6 months
|
We test the antirabies antibody titer before and after the single booster dose
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Anticipated)
August 1, 2010
Study Completion (Anticipated)
September 1, 2010
Study Registration Dates
First Submitted
July 19, 2010
First Submitted That Met QC Criteria
July 30, 2010
First Posted (Estimate)
August 2, 2010
Study Record Updates
Last Update Posted (Estimate)
August 2, 2010
Last Update Submitted That Met QC Criteria
July 30, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PKUPH-ER-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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