Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Aga Khan University
Wellcome Trust
University of Western Ontario, Canada
GlaxoSmithKline
Information provided by:
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT00125047
First received: July 28, 2005
Last updated: August 25, 2008
Last verified: August 2008

July 28, 2005
August 25, 2008
October 2001
August 2007   (final data collection date for primary outcome measure)
Total protection against S. typhi [ Time Frame: 2 years from zero time ] [ Designated as safety issue: No ]
  • Vaccine effectiveness
  • Cost-effectiveness of typhoid Vi immunization
  • Logistic feasibility of mass typhoid immunization campaign
Complete list of historical versions of study NCT00125047 on ClinicalTrials.gov Archive Site
  • Indirect protection against s. typhi [ Time Frame: two years from zero time ] [ Designated as safety issue: No ]
  • Overall protection against s. typhi [ Time Frame: 2 years from zero time ] [ Designated as safety issue: No ]
  • Adverse event(s) following immunization [ Time Frame: 30 days from vaccination ] [ Designated as safety issue: Yes ]
  • Adverse events
  • Anti-Vi antibody response
Not Provided
Not Provided
 
Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood
Effectiveness of a Combined Vi Vaccination and Health Education Program on Reducing the Burden of Typhoid During Childhood: A Demonstration Project in Karachi

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Typhoid
  • Paratyphoid Fever
  • Biological: Typhoid Vi vaccine
    Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.
    Other Name: Typherix
  • Biological: Hepatitis A vaccine
    single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen
    Other Name: Havrix
  • Experimental: 1
    Typhoid Vi polysaccharide vaccine
    Intervention: Biological: Typhoid Vi vaccine
  • Active Comparator: 2
    Inactivated Hepatitis A vaccine
    Intervention: Biological: Hepatitis A vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27231
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Registered in the project census
  • Age: 2-16 years

Exclusion Criteria:

  • Fever >37.5 degrees Celsius, axillary
  • Pregnancy
  • Lactating
Both
2 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT00125047
T-7
Yes
Mr. Leon Ochiai, International Vaccine Institute
International Vaccine Institute
  • Aga Khan University
  • Wellcome Trust
  • University of Western Ontario, Canada
  • GlaxoSmithKline
Principal Investigator: Zulfiqar A Bhutta, MBBS, PhD Aga Khan University
International Vaccine Institute
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP