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Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00131833
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : March 13, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Typhoid Paratyphoid Fever Biological: Typhoid Vi vaccine Biological: Meningococcal A (control) Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96468 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
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 Start Date : October 2001
Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. vaccine effectiveness
  2. cost effectiveness of typhoid Vi immunization
  3. adverse events

Secondary Outcome Measures :
  1. logistic feasibility of mass typhoid immunization
  2. anti-Vi antibody response
  3. knowledge, attitudes, beliefs and practices of parents and health care providers on typhoid fever prevention and treatment
  4. Typhoid risk factors

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Registered in the project census

Exclusion Criteria:

  • Pregnant
  • Lactating
  • Fever > 37.5 degrees Celsius, axillary
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131833

China, Guangxi
Hechi City Center for Disease Control
Hechi City, Guangxi, China, 54700
Sponsors and Collaborators
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
More Information

Responsible Party: Mr. Leon Ochiai, International Vaccine Institute
ClinicalTrials.gov Identifier: NCT00131833     History of Changes
Other Study ID Numbers: T3
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008

Keywords provided by International Vaccine Institute:
typhoid vaccine
enteric fever

Additional relevant MeSH terms:
Typhoid Fever
Paratyphoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs