The Protection Effect of Speeda® Rabies Vaccine for Human Use

Phase 4

Completed

• Conditions: Rabies Vaccine Allergy
• Interventions: Biological: rabies vaccine

• Registration Number: NCT01827917
• Lead Sponsor: Beijing Center for Disease Control and Prevention

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-27
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-10
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rabies vaccine	rabies vaccine	When injured by the animal who carries the rabies virus, the patient after standard treatment would survive or die

Primary Outcome Measures

Name	Time	Method
Observation of the subject after injured by the animals carrying the virus	2 years	Whether or when would the patients develop symptoms after injured by the animals carrying the virus

Trial Locations

Locations (1)

Hunan Centers for Disease Control and Prevention; 🇨🇳 Changsha, Hunan, China