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

Phase 4

Completed

• Conditions: Rabies Vaccine Allergy; Anti-D Antibodies; Vaccination Adverse Event
• Interventions: Biological: Zagreb2-1-1; Biological: Essen

• Registration Number: NCT01821911
• Lead Sponsor: Beijing Center for Disease Control and Prevention

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-03-29
• Status Verified: 2013-04
• Study First Posted: 2013-04-01
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Essen	Zagreb2-1-1	Injection on day 0、3、7、14、28
Zagreb2-1-1	Essen	Injection on day 0、7、21
Essen	Essen	Injection on day 0、3、7、14、28
Zagreb2-1-1	Zagreb2-1-1	Injection on day 0、7、21

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Adverse Events of the rabies vaccine each injection	2 years

Secondary Outcome Measures

Name	Time	Method
Antibody titre of the subject on 0、7、14、42、180、365	3 years

Trial Locations

Locations (3)

Wuhan Centers for Disease Control and Prevention; 🇨🇳 Wuhan, Hubei, China

Guangdong Centers for Disease Control and Prevention; 🇨🇳 Zhaoqing, Guangdong, China

Beijing Chaoyang District Centers for Disease Control and Prevention; 🇨🇳 Beijing, China