Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood - Full Text View

Sponsor:	International Vaccine Institute
Collaborators:	Aga Khan University Wellcome Trust University of Western Ontario, Canada GlaxoSmithKline
Information provided by:	International Vaccine Institute
ClinicalTrials.gov Identifier:	NCT00125047

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Childhood Immunization Fever Hepatitis Hepatitis A

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

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
1: Experimental Typhoid Vi polysaccharide vaccine	Biological: Typhoid Vi vaccine Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.
2: Active Comparator Inactivated Hepatitis A vaccine	Biological: Hepatitis A vaccine single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen

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

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:

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.

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.

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

Keywords provided by International Vaccine Institute:

Salmonellosis
typhoid vaccine
enteric fever

Additional relevant MeSH terms:

Bacterial Infections
Enterobacteriaceae Infections
Salmonella Infections

Typhoid Fever
Paratyphoid Fever
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on February 08, 2010