Back to resultsThe Protection Effect of Speeda® Rabies Vaccine for Human Use
Primary Purpose
Rabies Vaccine Allergy
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
rabies vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Rabies Vaccine Allergy
Eligibility Criteria
Inclusion Criteria:
- Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed
- Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months before injured
- The man-killer could found and detect whether it carries the virus
Exclusion Criteria:
- Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- Apply passive immunity preparation
Sites / Locations
- Hunan Centers for Disease Control and Prevention
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rabies vaccine
Arm Description
When injured by the animal who carries the rabies virus, the patient after standard treatment would survive or die
Outcomes
Primary Outcome Measures
Observation of the subject after injured by the animals carrying the virus
Whether or when would the patients develop symptoms after injured by the animals carrying the virus
Secondary Outcome Measures
Full Information
NCT ID
NCT01827917
First Posted
March 27, 2013
Last Updated
January 19, 2016
Sponsor
Beijing Center for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT01827917
Brief Title
The Protection Effect of Speeda® Rabies Vaccine for Human Use
Official Title
Phase 4 Study of Speeda® Rabies Vaccinia That Use for Protection the Crowd Bitten by Animals to Three-level
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Center for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was to achieve the post-marketing protective effect research of Speeda® rabies vaccine for human use from Chengda Bio.
Detailed Description
When found the injury who is bitten by the animal to three-level, the investigators would enroll the participant after explaining the protection and making him signed the informed consent. The patient would inject rabies vaccine as follow the national regulation, meanwhile the investigators would get the blood samples to detect whether the man-killer carries the rabies virus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies Vaccine Allergy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rabies vaccine
Arm Type
Experimental
Arm Description
When injured by the animal who carries the rabies virus, the patient after standard treatment would survive or die
Intervention Type
Biological
Intervention Name(s)
rabies vaccine
Intervention Description
Injection on day 0、7、21
Primary Outcome Measure Information:
Title
Observation of the subject after injured by the animals carrying the virus
Description
Whether or when would the patients develop symptoms after injured by the animals carrying the virus
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed
Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months before injured
The man-killer could found and detect whether it carries the virus
Exclusion Criteria:
Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
Apply passive immunity preparation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nianmin Shi
Organizational Affiliation
Beijing Chaoyang District Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Centers for Disease Control and Prevention
City
Changsha
State/Province
Hunan
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
28121231
Citation
Shi N, Zhang Y, Zheng H, Zhu Z, Wang D, Li S, Li Y, Yang L, Zhang J, Bai Y, Lu Q, Zhang Z, Luo F, Yu C, Li L. Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-8. doi: 10.1080/21645515.2017.1279770. Epub 2017 Jan 25.
Results Reference
derived
Learn more about this trial
The Protection Effect of Speeda® Rabies Vaccine for Human Use
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