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

checkorphan
Learn more about:
Typhoid fever
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

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

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

Brief 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.

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 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 Phase

Phase 4

Study Type

Interventional

Primary Outcome

Total protection against S. typhi

Secondary Outcome

 Indirect protection against s. typhi

Condition

Typhoid

Intervention

Typhoid Vi vaccine

Study Arms / Comparison Groups

 1
Description:  Typhoid Vi polysaccharide vaccine

Publications

* 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

Biological

Estimated Enrollment

27231

Start Date

October 2001

Completion Date

August 2007

Primary Completion Date

August 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Registered in the project census

          -  Age: 2-16 years

        Exclusion Criteria:

          -  Fever >37.5 degrees Celsius, axillary

          -  Pregnancy

          -  Lactating

Gender

All

Ages

2 Years - 16 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Zulfiqar A Bhutta, MBBS, PhD, ,

Location Countries

Pakistan

Location Countries

Pakistan

Administrative Informations

NCT ID

NCT00125047

Organization ID

T-7

Study Sponsor

International Vaccine Institute

Collaborators

 Aga Khan University

Study Sponsor

Zulfiqar A Bhutta, MBBS, PhD, Principal Investigator, Aga Khan University

Verification Date

August 2008