Clinical Trials Logo
  1. Home
  2. Typhoid
  3. NCT00125047

Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood

Typhoid Clinical Trial

Official title:
Effectiveness of a Combined Vi Vaccination and Health Education Program on Reducing the Burden of Typhoid During Childhood: A Demonstration Project in Karachi

Clinical Trial Summary

This study is part of the International Vaccine Institute's (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 Karachi, Pakistan. The cost-effectiveness of Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.

Clinical Trial 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. A cluster-randomized trial involving the Vi polysaccharide vaccine and an active control (hepatitis A) was designed to determine the effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 3 urban slums in Pakistan. The vaccines used in this study are internationally produced and locally licensed. A complimentary, targeted, basic typhoid prevention health education program for the entire population at the initiation of the project will be provided and the actual Vi-demonstration project will be preceded by a 12-month typhoid surveillance activity.

Secondary objectives of this trial are:

- To monitor the adverse events following a routine Vi mass vaccination campaign;

- To assess the knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention; and

- To study typhoid fever risk factors in the population.

A nested, prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in Karachi. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00125047
Study type Interventional
Source International Vaccine Institute
Contact
Status Completed
Phase Phase 4
Start date October 2001
Completion date August 2007
View Details
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 NCT00131833 - Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China 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