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Completed

NCT Number: NCT00131833

Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China

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.

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Key information

Conditions

Typhoid Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infections Paratyphoid Fever Salmonella Infections Typhoid Fever

Age range

5 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hechi City Center for Disease Control

Hechi, Guangxi, 54700, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Registered in the project census

Exclusion criteria

  • Pregnant
  • Lactating
  • Fever > 37.5 degrees Celsius, axillary

Treatment and study plan

Typhoid Vi vaccine

Biological

Meningococcal A (control)

Biological

Primary outcomes

  1. vaccine effectiveness

  2. cost effectiveness of typhoid Vi immunization

  3. adverse events

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

International Vaccine Institute

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Hechi City Center for Disease Centrol
  • University of Western Ontario, Canada
  • Wellcome Trust

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Aug 19, 2005
Registry last updated
Mar 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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