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
  Purpose

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.


Condition Intervention Phase
Typhoid
Paratyphoid Fever
Biological: Typhoid Vi vaccine
Biological: Hepatitis A vaccine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:
  • Total protection against S. typhi [ Time Frame: 2 years from zero time ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27231
Study Start Date: October 2001
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Typhoid Vi polysaccharide vaccine
Biological: Typhoid Vi vaccine
Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.
Other Name: Typherix
Active Comparator: 2
Inactivated Hepatitis A vaccine
Biological: Hepatitis A vaccine
single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen
Other Name: Havrix

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.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Fever >37.5 degrees Celsius, axillary
  • Pregnancy
  • Lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125047

Locations
Pakistan
Aga Khan University
Karachi, Pakistan
Sponsors and Collaborators
International Vaccine Institute
Aga Khan University
Wellcome Trust
University of Western Ontario, Canada
GlaxoSmithKline
Investigators
Principal Investigator: Zulfiqar A Bhutta, MBBS, PhD Aga Khan University
  More Information

Publications:
Responsible Party: Mr. Leon Ochiai, International Vaccine Institute
ClinicalTrials.gov Identifier: NCT00125047     History of Changes
Other Study ID Numbers: T-7
Study First Received: July 28, 2005
Last Updated: August 25, 2008
Health Authority: Pakistan: Ministry of Health

Keywords provided by International Vaccine Institute:
Salmonellosis
typhoid vaccine
enteric fever

Additional relevant MeSH terms:
Fever
Paratyphoid Fever
Typhoid Fever
Body Temperature Changes
Signs and Symptoms
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 14, 2014