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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01821911
Recruitment Status : Completed
First Posted : April 1, 2013
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment Phase
Rabies Vaccine Allergy Vaccination Adverse Event Anti-D Antibodies Biological: Zagreb2-1-1 Biological: Essen Phase 4

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Speeda® Rabies Vaccine for Human Use
Study Start Date : July 2012
Primary Completion Date : December 2013
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Zagreb2-1-1
Injection on day 0、7、21
Biological: Zagreb2-1-1
Injection on day 0、7、21
Biological: Essen
Injection on day 0、3、7、14、28
Active Comparator: Essen
Injection on day 0、3、7、14、28
Biological: Zagreb2-1-1
Injection on day 0、7、21
Biological: Essen
Injection on day 0、3、7、14、28


Outcome Measures

Primary Outcome Measures :
  1. Incidence Rate of Adverse Events of the rabies vaccine each injection [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Antibody titre of the subject on 0、7、14、42、180、365 [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
  • 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
Contacts and Locations

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): NCT01821911


Locations
China, Guangdong
Guangdong Centers for Disease Control and Prevention
Zhaoqing, Guangdong, China
China, Hubei
Wuhan Centers for Disease Control and Prevention
Wuhan, Hubei, China
China
Beijing Chaoyang District Centers for Disease Control and Prevention
Beijing, China
Sponsors and Collaborators
Beijing Center for Disease Control and Prevention
Investigators
Principal Investigator: Nianmin Shi Beijing Chaoyang District Centers for Disease Control and Prevention
More Information

Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01821911     History of Changes
Other Study ID Numbers: BJCDPC-5
First Posted: April 1, 2013    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: April 2013

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases