The Protection Effect of Speeda® Rabies Vaccine for Human Use

NCT01827917 | Completed Phase 4

• 1 other identifier: BJCDPC-6
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to achieve the post-marketing protective effect research of Speeda® rabies vaccine for human use from Chengda Bio.

Conditions

Rabies Vaccine Allergy

Outcome Measures

Primary Outcomes (1)

• Observation of the subject after injured by the animals carrying the virus

  Whether or when would the patients develop symptoms after injured by the animals carrying the virus

  2 years

Study Arms (1)

rabies vaccine

EXPERIMENTAL

When injured by the animal who carries the rabies virus, the patient after standard treatment would survive or die

Biological: rabies vaccine

Interventions

rabies vaccine BIOLOGICAL

Injection on day 0、7、21

rabies vaccine

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 before injured
• The man-killer could found and detect whether it carries the virus

You may not qualify if:

• Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
• Apply passive immunity preparation

Sponsors & Collaborators

• Beijing Center for Disease Control and Prevention: lead

Study Sites (1)

Hunan Centers for Disease Control and Prevention

Changsha, Hunan, 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

MeSH Terms

Interventions

Rabies Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Nianmin Shi

  Beijing Chaoyang District Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 10, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 20, 2016

Record last verified: 2013-04

Locations

CN (1)