The Post-Marketing Safety and Immunogenicity Research of Speeda® Rabies Vaccine for Human Use

Vaccination Adverse Event Clinical Trial

Official title:

Phase 4 Study of Speeda® Rabies Vaccine for Human Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821911
• Other study ID #: BJCDPC-5
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10500
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

• Participant body temperature = 37.0?

• Participant without preventive inoculation of rabies vaccine(only limited in immunogenicity subgroup)

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Anti-D Antibodies
• Rabies
• Rabies Vaccine Allergy
• Vaccination Adverse Event

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