Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China
Primary Purpose
Typhoid, Paratyphoid Fever
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Typhoid Vi vaccine
Meningococcal A (control)
Sponsored by
About this trial
This is an interventional prevention trial for Typhoid focused on measuring salmonella, typhoid vaccine, enteric fever
Eligibility Criteria
Inclusion Criteria: Registered in the project census Exclusion Criteria: Pregnant Lactating Fever > 37.5 degrees Celsius, axillary
Sites / Locations
- Hechi City Center for Disease Control
Outcomes
Primary Outcome Measures
vaccine effectiveness
cost effectiveness of typhoid Vi immunization
adverse events
Secondary Outcome Measures
logistic feasibility of mass typhoid immunization
anti-Vi antibody response
knowledge, attitudes, beliefs and practices of parents and health care providers on typhoid fever prevention and treatment
Typhoid risk factors
Full Information
NCT ID
NCT00131833
First Posted
August 18, 2005
Last Updated
March 10, 2008
Sponsor
International Vaccine Institute
Collaborators
Centers for Disease Control and Prevention, Hechi City Center for Disease Centrol, Wellcome Trust, University of Western Ontario, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00131833
Brief Title
Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China
Official Title
Typhoid Vi Vaccine Effectiveness in a Population Older Than 5 Years of Age Living in an Endemic Area in Hechi, Guangxi, P.R. China: A Group-Randomized Controlled Demonstration Project
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
International Vaccine Institute
Collaborators
Centers for Disease Control and Prevention, Hechi City Center for Disease Centrol, Wellcome Trust, University of Western Ontario, Canada
4. Oversight
5. Study Description
Brief Summary
This study is part of International Vaccine Institute (IVI)'s typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries. The purpose of this study is to determine the effectiveness of the Vi vaccine following a mass typhoid immunization campaign in an endemic area in Hechi City in the Guangxhi province of China. The cost-effectiveness and safety of Vi vaccination will also be evaluated.
Detailed Description
Typhoid fever is a major cause of morbidity worldwide. The disease predominantly affects school-aged children, is more prevalent in urban areas, may last for several weeks and can lead to serious complications. Management of this disease is further complicated by the emergence of multi-drug resistant strains. Vaccination of high risk populations is considered the most promising strategy for the control of typhoid fever. The Vi polysaccharide vaccine has been targeted for accelerated introduction into public health programs due to the following reasons: it has been shown to have consistent efficacy results even in areas of high typhoid incidence, is given as a single dose, lacks patent protection and requires less strict cold chain requirements.
This project attempts to evaluate a new vaccination strategy for residents of endemic areas. A cluster-randomized trial involving the Vi polysaccharide vaccine and an active control (meningococcal A vaccine) was designed to determine the effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 2 populous townships of Hechi City. The vaccines used in this study are locally produced and licensed in China. A 1 year pilot phase will precede the actual Vi-demonstration project. Surveillance for typhoid fever cases will continue after the mass immunization campaign. A passive surveillance system to evaluate adverse events following immunization will be implemented. Socio-economic studies will be conducted in parallel to the effectiveness evaluation. The knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention will be assessed. Logistic, feasibility and vaccine costs will also be determined.
Secondary objectives of this trial are:
To estimate the logistic feasibility of a mass typhoid immunization campaign
To assess the knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention
To study typhoid fever risk factors in the population
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typhoid, Paratyphoid Fever
Keywords
salmonella, typhoid vaccine, enteric fever
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
96468 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Typhoid Vi vaccine
Intervention Type
Biological
Intervention Name(s)
Meningococcal A (control)
Primary Outcome Measure Information:
Title
vaccine effectiveness
Title
cost effectiveness of typhoid Vi immunization
Title
adverse events
Secondary Outcome Measure Information:
Title
logistic feasibility of mass typhoid immunization
Title
anti-Vi antibody response
Title
knowledge, attitudes, beliefs and practices of parents and health care providers on typhoid fever prevention and treatment
Title
Typhoid risk factors
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Registered in the project census
Exclusion Criteria:
Pregnant
Lactating
Fever > 37.5 degrees Celsius, axillary
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Baiqing, MD
Organizational Affiliation
Guangxi Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hechi City Center for Disease Control
City
Hechi City
State/Province
Guangxi
ZIP/Postal Code
54700
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
15921608
Citation
Dong BQ, Yang J, Tang ZZ, Yang HH, Zeng J, Zhang J, Wang ML, Liang GC, Si GA, Li CY, Liang DB, Liao HZ, Ochiai RL, Mohammad A, Acosta CJ, Clemens J. [Application of cluster randomization method on typhoid Vi vaccine trails]. Zhonghua Liu Xing Bing Xue Za Zhi. 2005 Feb;26(2):97-100. Chinese.
Results Reference
background
PubMed Identifier
15904514
Citation
Yang J, Acosta CJ, Si GA, Zeng J, Li CY, Liang DB, Ochiai RL, Page AL, Danovaro-Holliday MC, Zhang J, Zhou BD, Liao HZ, Wang ML, Tan DM, Tang ZZ, Gong J, Park JK, Ali M, Ivanoff B, Liang GC, Yang HH, Pang T, Xu ZY, Donner A, Galindo CM, Dong BQ, Clemens JD. A mass vaccination campaign targeting adults and children to prevent typhoid fever in Hechi; expanding the use of Vi polysaccharide vaccine in southeast China: a cluster-randomized trial. BMC Public Health. 2005 May 18;5:49. doi: 10.1186/1471-2458-5-49.
Results Reference
background
PubMed Identifier
15609776
Citation
Acosta CJ, Galindo CM, Ochiai RL, Danovaro-Holliday MC, Page AL, Thiem VD, Park JK, Park E, Koo H, Wang XY, Abu-Elyazeed R, Ali M, Albert MJ, Ivanoff B, Pang T, Xu ZY, Clemens JD. The role of epidemiology in the introduction of vi polysaccharide typhoid fever vaccines in Asia. J Health Popul Nutr. 2004 Sep;22(3):240-5.
Results Reference
background
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Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China
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