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

Typhoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125047
• Other study ID #: T-7
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2005
• Last updated: August 25, 2008
• Start date: October 2001
• Est. completion date: August 2007

Study information

• Verified date: August 2008
• Source: International Vaccine Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27231
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

• Registered in the project census

• Age: 2-16 years

Exclusion Criteria:

• Fever >37.5 degrees Celsius, axillary

• Pregnancy

• Lactating

Study Design

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

Related Conditions & MeSH terms

• Paratyphoid Fever
• Typhoid
• Typhoid Fever

Intervention

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

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi

Sponsors (5)

Lead Sponsor	Collaborator
International Vaccine Institute	Aga Khan University, GlaxoSmithKline, University of Western Ontario, Canada, Wellcome Trust

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total protection against S. typhi		2 years from zero time	No
Secondary	Indirect protection against s. typhi		two years from zero time	No
Secondary	Overall protection against s. typhi		2 years from zero time	No
Secondary	Adverse event(s) following immunization		30 days from vaccination	Yes