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

NCT01821911 | Completed Phase 4

• 1 other identifier: BJCDPC-5
• Study Type: interventional
• Target: 10,500
• Locations: 1 country
• Sites: 3

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of Adverse Events of the rabies vaccine each injection

  2 years

Secondary Outcomes (1)

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

  3 years

Study Arms (2)

Zagreb2-1-1

EXPERIMENTAL

Injection on day 0、7、21

Biological: Zagreb2-1-1; Biological: Essen

Essen

ACTIVE COMPARATOR

Injection on day 0、3、7、14、28

Biological: Zagreb2-1-1; Biological: Essen

Interventions

Zagreb2-1-1 BIOLOGICAL

Injection on day 0、7、21

Essen; Zagreb2-1-1

Essen BIOLOGICAL

Injection on day 0、3、7、14、28

Essen; Zagreb2-1-1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Center for Disease Control and Prevention: lead

Study Sites (3)

Guangdong Centers for Disease Control and Prevention

Zhaoqing, Guangdong, China

Location

Wuhan Centers for Disease Control and Prevention

Wuhan, Hubei, China

Location

Beijing Chaoyang District Centers for Disease Control and Prevention

Beijing, China

Location

Related Publications (2)

• Li L, Xu J, Zhang J, Wang F, Cai J, Yang L, Zhu Z, Bai Y, Jia B, Ma J, Shi N, Li S. Immunogenicity and immune persistence of Zagreb 2-1-1 regimen of rabies vaccine in Chinese healthy individuals: A randomized, parallel-controlled of homologous vaccine with different immune procedure study. Hum Vaccin Immunother. 2024 Dec 31;20(1):2403177. doi: 10.1080/21645515.2024.2403177. Epub 2024 Oct 2.

  PMID: 39358206 DERIVED

• 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.

  PMID: 28121231 DERIVED

Study Officials

• Nianmin Shi

  Beijing Chaoyang District Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 1, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 20, 2016

Record last verified: 2013-04

Locations

CN (3)