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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01821911
Other study ID # BJCDPC-5
Secondary ID
Status Completed
Phase Phase 4
First received March 27, 2013
Last updated January 19, 2016
Start date July 2012
Est. completion date December 2014

Study information

Verified date April 2013
Source Beijing Center for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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


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.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
Zagreb2-1-1
Injection on day 0?7?21
Essen
Injection on day 0?3?7?14?28

Locations

Country Name City State
China Beijing Chaoyang District Centers for Disease Control and Prevention Beijing
China Wuhan Centers for Disease Control and Prevention Wuhan Hubei
China Guangdong Centers for Disease Control and Prevention Zhaoqing Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Beijing Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence Rate of Adverse Events of the rabies vaccine each injection 2 years Yes
Secondary Antibody titre of the subject on 0?7?14?42?180?365 3 years No
See also
  Status Clinical Trial Phase
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Completed NCT02133456 - A Post-marketing Safety Study of Inactivated, Split-virion Influenza Vaccine in Subjects Aged 3 Years and Older N/A
Completed NCT01963338 - A Study to Assess the Acceptability and Usability of a New Device for Intradermal Vaccination N/A