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

January 19, 2016 updated by: Beijing Center for Disease Control and Prevention

Phase 4 Study 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Chaoyang District Centers for Disease Control and Prevention
    • Guangdong
      • Zhaoqing, Guangdong, China
        • Guangdong Centers for Disease Control and Prevention
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan Centers for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence Rate of Adverse Events of the rabies vaccine each injection
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Antibody titre of the subject on 0、7、14、42、180、365
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Center for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

March 29, 2013

First Posted (Estimate)

April 1, 2013

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJCDPC-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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