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Trial record 41 of 76 for:    "Rabies" | "Immunologic Factors"

The Protection Effect of Speeda® Rabies Vaccine for Human Use

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ClinicalTrials.gov Identifier: NCT01827917
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rabies Vaccine Allergy Biological: rabies vaccine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Speeda® Rabies Vaccinia That Use for Protection the Crowd Bitten by Animals to Three-level
Study Start Date : February 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Experimental: rabies vaccine
When injured by the animal who carries the rabies virus, the patient after standard treatment would survive or die
Biological: rabies vaccine
Injection on day 0、7、21




Primary Outcome Measures :
  1. Observation of the subject after injured by the animals carrying the virus [ Time Frame: 2 years ]
    Whether or when would the patients develop symptoms after injured by the animals carrying the virus



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827917


Locations
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China, Hunan
Hunan Centers for Disease Control and Prevention
Changsha, Hunan, China
Sponsors and Collaborators
Beijing Center for Disease Control and Prevention
Investigators
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Principal Investigator: Nianmin Shi Beijing Chaoyang District Centers for Disease Control and Prevention

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01827917     History of Changes
Other Study ID Numbers: BJCDPC-6
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: April 2013

Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs