Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam

Learn more about:
Related Clinical Trial
Non-inferiority Trial of Locally Manufactured Typhoid Conjugate Vaccine ‘Typhocon’ in Bangladesh Effectiveness of a Typhoid Conjugate Vaccine in DRC Transcriptomic Responses for the Identification of Pathogens Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants Commercial Typhoid Tests Validation Trial Commercial Typhoid Tests Validation WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial) Phase 4 Study To Assess The Safety Of Vivotif At Different Release Titers Among Travelers Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old) Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old) Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Safety and Immunogenicity of Typhax, a Typhoid Vaccine Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III) Investigating Enteric Fever – Salmonella Typhi and Paratyphi Challenge Study Induction of Gut Permeability by an Oral Vaccine Studies of Immune Responses to Orally Administered Vaccines in Developing Country Long Term Protection by and Persistence of Vi Antibodies Induced by Vi-rEPA Conjugate Vaccines in Vietnamese Children Injected at 2-5 Years or at 5-8 Years of Age Salmonella Typhi Vi O-Acetyl Pectin-rEPA Conjugate Vaccine Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants Typhoid Fever: Combined vs. Single Antibiotic Therapy Vaccines Against Salmonella Typhi Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults CVD 909 Vi Prime Boost Study Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine Typhoid Conjugate Vaccine Introduction in Navi Mumbai, India Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso Understanding Typhoid Disease After Vaccination Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood Global Genomic and Proteomic Profiling of African Children With Typhoid Fever

Brief Title

Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam

Official Title

Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam. An Evaluation of Feasibility, Public Acceptability, Effectiveness and Cost-Effectiveness in Students

Brief Summary

      This study is part of International Vaccine Institutes (IVI)'s typhoid Vi demonstration
      project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic
      countries. The primary objectives of the study are to evaluate the logistic feasibility of a
      mass typhoid fever immunization campaign program targeting school age children in Hue City,
      Vietnam and to assess the knowledge, attitudes, beliefs, and practices of parents and
      healthcare providers in Hue City regarding typhoid fever prevention and treatment.

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. A cluster-randomized trial involving the Vi polysaccharide
      vaccine and an active control (Hepatitis A) was designed to determine the logistic
      feasibility of providing Vi vaccine under actual programmatic conditions among school
      students in Hue City. The vaccines used in this study are internationally produced and
      locally licensed.

      Secondary objectives of this trial are:

        -  To estimate the cost-effectiveness (cost of illness, willingness to pay, vaccine
           delivery costs, private vaccine costs, etc) of Vi vaccination

        -  To determine the effectiveness of the Vi polysaccharide vaccine following routine
           administration of a 1-dose schedule to school students (aged >=6 years)

        -  To determine the safety and immunogenicity of the Vi vaccine

        -  To study typhoid risk factors among students

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

Study Phase

Phase 4

Study Type


Primary Outcome

Logistic feasibility of mass typhoid immunization campaign

Secondary Outcome

 Cost-effectiveness of vaccine




Typhoid Vi vaccine


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

December 2001

Completion Date

January 2007

Primary Completion Date

January 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Local students whose parents/guardians provide written consent to receive Vi vaccine

          -  Attending any of the 66 registered schools in Hue

          -  Registered in the project census

          -  Lives in Hue City

        Exclusion Criteria:

          -  Fever (>37.5 degrees Celsius, axillary)

          -  Pregnancy

          -  Lactating




5 Years - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Canh G Do, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Study Sponsor

International Vaccine Institute


 National Institute of Hygiene and Epidemiology, Vietnam

Study Sponsor

Canh G Do, MD, Principal Investigator, National Institute of Hygiene and Epidemiology, Vietnam

Verification Date

March 2008