Status:
COMPLETED
The Post-Marketing Safety and Immunogenicity Research of Speeda® Rabies Vaccine for Human Use
Lead Sponsor:
Beijing Center for Disease Control and Prevention
Conditions:
Rabies Vaccine Allergy
Vaccination Adverse Event
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The objective of this study was to achieve the post-marketing safety and immunogenicity research of Speeda® rabies vaccine for human use from Chengda Bio
Detailed Description
The aim of the research is to compare the two immune procedures. The investigators plan to enroll 10500 participants signed the informed consent who separately inject by Zagreb or Essen procedure.
Eligibility Criteria
Inclusion
- 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
- Participant body temperature ≤ 37.0℃
- Participant without preventive inoculation of rabies vaccine(only limited in immunogenicity subgroup)
Exclusion
- Three-level exposure
- Known allergy to any constituent of the vaccine
- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
- Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- Participation in any other interventional clinical trial
- An acute illness with or without fever (temperature \> 37.0℃) in the latest week preceding enrollment in the trial
- Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study
- Reported clearly the infection of the upper respiratory tract with 6 months Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
10500 Patients enrolled
Trial Details
Trial ID
NCT01821911
Start Date
July 1 2012
End Date
December 1 2014
Last Update
January 20 2016
Active Locations (3)
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1
Guangdong Centers for Disease Control and Prevention
Zhaoqing, Guangdong, China
2
Wuhan Centers for Disease Control and Prevention
Wuhan, Hubei, China
3
Beijing Chaoyang District Centers for Disease Control and Prevention
Beijing, China