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OpenTrials
Completed

NCT Number: NCT01827917

The Protection Effect of Speeda® Rabies Vaccine for Human Use

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hunan Centers for Disease Control and Prevention

Changsha, Hunan, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rabies vaccine

Biological

Injection on day 0、7、21

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Beijing Center for Disease Control and Prevention

Other Gov

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Apr 10, 2013
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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