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

Primary Purpose

Typhoid, Paratyphoid Fever

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Typhoid Vi vaccine
Hepatitis A vaccine
Sponsored by
International Vaccine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Typhoid focused on measuring Salmonellosis, typhoid vaccine, enteric fever

Eligibility Criteria

2 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Registered in the project census Age: 2-16 years Exclusion Criteria: Fever >37.5 degrees Celsius, axillary Pregnancy Lactating

Sites / Locations

  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Typhoid Vi polysaccharide vaccine

Inactivated Hepatitis A vaccine

Outcomes

Primary Outcome Measures

Total protection against S. typhi

Secondary Outcome Measures

Indirect protection against s. typhi
Overall protection against s. typhi
Adverse event(s) following immunization

Full Information

First Posted
July 28, 2005
Last Updated
August 25, 2008
Sponsor
International Vaccine Institute
Collaborators
Aga Khan University, Wellcome Trust, University of Western Ontario, Canada, GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00125047
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
International Vaccine Institute
Collaborators
Aga Khan University, Wellcome Trust, University of Western Ontario, Canada, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typhoid, Paratyphoid Fever
Keywords
Salmonellosis, typhoid vaccine, enteric fever

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Typhoid Vi polysaccharide vaccine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Inactivated Hepatitis A vaccine
Intervention Type
Biological
Intervention Name(s)
Typhoid Vi vaccine
Other Intervention Name(s)
Typherix
Intervention Description
Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.
Intervention Type
Biological
Intervention Name(s)
Hepatitis A vaccine
Other Intervention Name(s)
Havrix
Intervention Description
single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen
Primary Outcome Measure Information:
Title
Total protection against S. typhi
Time Frame
2 years from zero time
Secondary Outcome Measure Information:
Title
Indirect protection against s. typhi
Time Frame
two years from zero time
Title
Overall protection against s. typhi
Time Frame
2 years from zero time
Title
Adverse event(s) following immunization
Time Frame
30 days from vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Registered in the project census Age: 2-16 years Exclusion Criteria: Fever >37.5 degrees Celsius, axillary Pregnancy Lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zulfiqar A Bhutta, MBBS, PhD
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
15450121
Citation
Ali M, Rasool S, Park JK, Saeed S, Ochiai RL, Nizami Q, Acosta CJ, Bhutta Z. Use of satellite imagery in constructing a household GIS database for health studies in Karachi, Pakistan. Int J Health Geogr. 2004 Sep 28;3(1):20. doi: 10.1186/1476-072X-3-20.
Results Reference
background
PubMed Identifier
15609776
Citation
Acosta CJ, Galindo CM, Ochiai RL, Danovaro-Holliday MC, Page AL, Thiem VD, Park JK, Park E, Koo H, Wang XY, Abu-Elyazeed R, Ali M, Albert MJ, Ivanoff B, Pang T, Xu ZY, Clemens JD. The role of epidemiology in the introduction of vi polysaccharide typhoid fever vaccines in Asia. J Health Popul Nutr. 2004 Sep;22(3):240-5.
Results Reference
background

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

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