The Protection Effect of Speeda® Rabies Vaccine for Human Use

Rabies Vaccine Allergy Clinical Trial

Official title:

Phase 4 Study of Speeda® Rabies Vaccinia That Use for Protection the Crowd Bitten by Animals to Three-level

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827917
• Other study ID #: BJCDPC-6
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2013
• Last updated: January 19, 2016
• Start date: February 2013
• 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 protective effect research of Speeda® rabies vaccine for human use from Chengda Bio.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• 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 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rabies
• Rabies Vaccine Allergy

Intervention

Biological:
• rabies vaccine
Injection on day 0?7?21

Locations

Country	Name	City	State
China	Hunan Centers for Disease Control and Prevention	Changsha	Hunan

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	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	2 years	No