The Protection Effect of Speeda® Rabies Vaccine for Human Use

NCT ID: NCT01827917

Last Updated: 2016-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Rabies Vaccine Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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rabies vaccine

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

Group Type EXPERIMENTAL

rabies vaccine

Intervention Type BIOLOGICAL

Injection on day 0、7、21

Interventions

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rabies vaccine

Injection on day 0、7、21

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nianmin Shi

Role: PRINCIPAL_INVESTIGATOR

Beijing Chaoyang District Centers for Disease Control and Prevention

Locations

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Hunan Centers for Disease Control and Prevention

Changsha, Hunan, China

Site Status

Countries

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China

References

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Li L, Xu J, Zhang J, Wang F, Cai J, Yang L, Zhu Z, Bai Y, Jia B, Ma J, Shi N, Li S. Immunogenicity and immune persistence of Zagreb 2-1-1 regimen of rabies vaccine in Chinese healthy individuals: A randomized, parallel-controlled of homologous vaccine with different immune procedure study. Hum Vaccin Immunother. 2024 Dec 31;20(1):2403177. doi: 10.1080/21645515.2024.2403177. Epub 2024 Oct 2.

Reference Type DERIVED
PMID: 39358206 (View on PubMed)

Shi N, Zhang Y, Zheng H, Zhu Z, Wang D, Li S, Li Y, Yang L, Zhang J, Bai Y, Lu Q, Zhang Z, Luo F, Yu C, Li L. Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-8. doi: 10.1080/21645515.2017.1279770. Epub 2017 Jan 25.

Reference Type DERIVED
PMID: 28121231 (View on PubMed)

Other Identifiers

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BJCDPC-6

Identifier Type: -

Identifier Source: org_study_id

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