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Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China

This study has been completed.
Sponsor:
Collaborators:
Hechi City Center for Disease Centrol
Wellcome Trust
University of Western Ontario, Canada
Information provided by:
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT00131833
First received: August 18, 2005
Last updated: March 10, 2008
Last verified: March 2008

August 18, 2005
March 10, 2008
October 2001
November 2006   (final data collection date for primary outcome measure)
  • vaccine effectiveness
  • cost effectiveness of typhoid Vi immunization
  • adverse events
Same as current
Complete list of historical versions of study NCT00131833 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China
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

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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Typhoid
  • Paratyphoid Fever
  • Biological: Typhoid Vi vaccine
  • Biological: Meningococcal A (control)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96468
November 2006
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Registered in the project census

Exclusion Criteria:

  • Pregnant
  • Lactating
  • Fever > 37.5 degrees Celsius, axillary
Both
5 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00131833
T3
Not Provided
Mr. Leon Ochiai, International Vaccine Institute
International Vaccine Institute
  • Centers for Disease Control and Prevention
  • Hechi City Center for Disease Centrol
  • Wellcome Trust
  • University of Western Ontario, Canada
Principal Investigator: Dong Baiqing, MD Guangxi Center for Disease Control and Prevention
International Vaccine Institute
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP