Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00131833
Other study ID # T3
Secondary ID
Status Completed
Phase Phase 4
First received August 18, 2005
Last updated March 10, 2008
Start date October 2001
Est. completion date November 2006

Study information

Verified date March 2008
Source International Vaccine Institute
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 96468
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 60 Years
Eligibility Inclusion Criteria:

- Registered in the project census

Exclusion Criteria:

- Pregnant

- Lactating

- Fever > 37.5 degrees Celsius, axillary

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Typhoid Vi vaccine

Meningococcal A (control)


Locations

Country Name City State
China Hechi City Center for Disease Control Hechi City Guangxi

Sponsors (5)

Lead Sponsor Collaborator
International Vaccine Institute Centers for Disease Control and Prevention, Hechi City Center for Disease Centrol, University of Western Ontario, Canada, Wellcome Trust

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary vaccine effectiveness
Primary cost effectiveness of typhoid Vi immunization
Primary adverse events
Secondary logistic feasibility of mass typhoid immunization
Secondary anti-Vi antibody response
Secondary knowledge, attitudes, beliefs and practices of parents and health care providers on typhoid fever prevention and treatment
Secondary Typhoid risk factors
See also
  Status Clinical Trial Phase
Completed NCT03312699 - Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Phase 1
Completed NCT01405521 - Understanding Typhoid Disease After Vaccination Phase 2
Completed NCT00125047 - Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood Phase 4
Not yet recruiting NCT05771779 - Co-administration Study of OCV, TCV and MR Phase 3
Completed NCT01466387 - A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults Phase 3
Active, not recruiting NCT03933098 - Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine Phase 3
Completed NCT00679172 - Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults Phase 2
Completed NCT00125008 - Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever Phase 4
Recruiting NCT04878549 - Transcriptomic Responses for the Identification of Pathogens
Completed NCT02645032 - Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine Phase 1
Recruiting NCT05475379 - Non-inferiority Trial of Locally Manufactured Typhoid Conjugate Vaccine 'Typhocon' in Bangladesh Phase 1/Phase 2
Completed NCT04204096 - Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III) Phase 3
Active, not recruiting NCT03299426 - Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi Phase 3
Completed NCT01019083 - Studies of Immune Responses to Orally Administered Vaccines in Developing Country Phase 1/Phase 2
Completed NCT03614533 - Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso Phase 2
Completed NCT00131820 - Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam Phase 4
Completed NCT03527355 - Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine Phase 2