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Completed

NCT Number: NCT01821911

The Post-Marketing Safety and Immunogenicity Research of Speeda® Rabies Vaccine for Human Use

The objective of this study was to achieve the post-marketing safety and immunogenicity research of Speeda® rabies vaccine for human use from Chengda Bio

Completed

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guangdong Centers for Disease Control and Prevention, Zhaoqing, Guangdong, China

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About this study

The aim of the research is to compare the two immune procedures. The investigators plan to enroll 10500 participants signed the informed consent who separately inject by Zagreb or Essen procedure.

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
  • Participant body temperature ≤ 37.0℃
  • Participant without preventive inoculation of rabies vaccine(only limited in immunogenicity subgroup)

Exclusion criteria

  • Three-level exposure
  • Known allergy to any constituent of the vaccine
  • Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
  • Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
  • Participation in any other interventional clinical trial
  • An acute illness with or without fever (temperature > 37.0℃) in the latest week preceding enrollment in the trial
  • Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study
  • Reported clearly the infection of the upper respiratory tract with 6 months Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Treatment and study plan

Zagreb2-1-1

Biological

Injection on day 0、7、21

Essen

Biological

Injection on day 0、3、7、14、28

Primary outcomes

  1. Incidence Rate of Adverse Events of the rabies vaccine each injection

    Time frame: 2 years

Secondary outcomes

  1. Antibody titre of the subject on 0、7、14、42、180、365

    Time frame: 3 years

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 Vaccine for Human Use

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Apr 1, 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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