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

Primary Purpose

Rabies Vaccine Allergy, Vaccination Adverse Event, Anti-D Antibodies

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Zagreb2-1-1
Essen
Sponsored by
Beijing Center for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rabies Vaccine Allergy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Guangdong Centers for Disease Control and Prevention
  • Wuhan Centers for Disease Control and Prevention
  • Beijing Chaoyang District Centers for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zagreb2-1-1

Essen

Arm Description

Injection on day 0、7、21

Injection on day 0、3、7、14、28

Outcomes

Primary Outcome Measures

Incidence Rate of Adverse Events of the rabies vaccine each injection

Secondary Outcome Measures

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

Full Information

First Posted
March 27, 2013
Last Updated
January 19, 2016
Sponsor
Beijing Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01821911
Brief Title
The Post-Marketing Safety and Immunogenicity Research of Speeda® Rabies Vaccine for Human Use
Official Title
Phase 4 Study of Speeda® Rabies Vaccine for Human Use
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Center for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies Vaccine Allergy, Vaccination Adverse Event, Anti-D Antibodies

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zagreb2-1-1
Arm Type
Experimental
Arm Description
Injection on day 0、7、21
Arm Title
Essen
Arm Type
Active Comparator
Arm Description
Injection on day 0、3、7、14、28
Intervention Type
Biological
Intervention Name(s)
Zagreb2-1-1
Intervention Description
Injection on day 0、7、21
Intervention Type
Biological
Intervention Name(s)
Essen
Intervention Description
Injection on day 0、3、7、14、28
Primary Outcome Measure Information:
Title
Incidence Rate of Adverse Events of the rabies vaccine each injection
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Antibody titre of the subject on 0、7、14、42、180、365
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nianmin Shi
Organizational Affiliation
Beijing Chaoyang District Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Centers for Disease Control and Prevention
City
Zhaoqing
State/Province
Guangdong
Country
China
Facility Name
Wuhan Centers for Disease Control and Prevention
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Beijing Chaoyang District Centers for Disease Control and Prevention
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28121231
Citation
Shi N, Zhang Y, Zheng H, Zhu Z, Wang D, Li S, Li Y, Yang L, Zhang J, Bai Y, Lu Q, Zhang Z, Luo F, Yu C, Li L. Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-8. doi: 10.1080/21645515.2017.1279770. Epub 2017 Jan 25.
Results Reference
derived

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

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