The Protection Effect of Speeda® Rabies Vaccine for Human Use

Beijing Center for Disease Prevention and Control

Status and phase: Completed; Phase 4

Conditions: Rabies Vaccine Allergy

Treatments: Biological: rabies vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01827917

BJCDPC-6

Details and patient eligibility

About

The objective of this study was to achieve the post-marketing protective effect research of Speeda® rabies vaccine for human use from Chengda Bio.

Full 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.

Enrollment: 37 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

rabies vaccine

Experimental group

Description:

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

Treatment:

Biological: rabies vaccine