Clinical trial NCT01821911: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rabies Vaccine Allergy
Vaccination Adverse Event
Anti-D Antibodies
Lead sponsor: Beijing Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
First posted: 2013-04-01
Enrollment: 10500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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

Primary outcomes:
measure: Incidence Rate of Adverse Events of the rabies vaccine each injection
timeFrame: 2 years
Secondary outcomes:
measure: Antibody titre of the subject on 0、7、14、42、180、365
timeFrame: 3 years
Other outcomes:
Locations:
city: Zhaoqing
country: China
facility: Guangdong Centers for Disease Control and Prevention
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Centers for Disease Control and Prevention
state: Hubei
city: Beijing
country: China
facility: Beijing Chaoyang District Centers for Disease Control and Prevention
Study officials:
affiliation: Beijing Chaoyang District Centers for Disease Control and Prevention
name: Nianmin Shi
role: PRINCIPAL_INVESTIGATOR
References:
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.