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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01821911
First received: March 27, 2013
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Rabies Vaccine Allergy
Vaccination Adverse Event
Anti-D Antibodies
Biological: Zagreb2-1-1
Biological: Essen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 4 Study of Speeda® Rabies Vaccine for Human Use

Resource links provided by NLM:


Further study details as provided by Beijing Center for Disease Control and Prevention:

Primary Outcome Measures:
  • Incidence Rate of Adverse Events of the rabies vaccine each injection [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antibody titre of the subject on 0、7、14、42、180、365 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 10500
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01821911     History of Changes
Other Study ID Numbers: BJCDPC-5
Study First Received: March 27, 2013
Last Updated: April 11, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014