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

NCT00125047 | Completed Phase 4 DMC

• 1 other identifier: T-7
• Study Type: interventional
• Target: 27,231
• Locations: 1 country
• Sites: 1

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.

Conditions

Typhoid; Paratyphoid Fever

Keywords

Salmonellosis; typhoid vaccine; enteric fever

Outcome Measures

Primary Outcomes (1)

• Total protection against S. typhi

  2 years from zero time

Secondary Outcomes (3)

• Indirect protection against s. typhi

  two years from zero time

• Overall protection against s. typhi

  2 years from zero time

• Adverse event(s) following immunization

  30 days from vaccination

Study Arms (2)

1

EXPERIMENTAL

Typhoid Vi polysaccharide vaccine

Biological: Typhoid Vi vaccine

2

ACTIVE COMPARATOR

Inactivated Hepatitis A vaccine

Biological: Hepatitis A vaccine

Interventions

Typhoid Vi vaccine BIOLOGICAL

Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.

Also known as: Typherix

1

Hepatitis A vaccine BIOLOGICAL

single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen

Also known as: Havrix

2

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Fever \>37.5 degrees Celsius, axillary
• Pregnancy
• Lactating

Sponsors & Collaborators

• International Vaccine Institute: lead
• Aga Khan University: collaborator
• Wellcome Trust: collaborator
• University of Western Ontario, Canada: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

Aga Khan University

Karachi, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 15450121 BACKGROUND

• 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.

  PMID: 15609776 BACKGROUND

MeSH Terms

Conditions

Typhoid Fever; Paratyphoid Fever; Salmonella Infections

Interventions

Vi polysaccharide vaccine, typhoid; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Zulfiqar A Bhutta, MBBS, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2005
• First Posted: July 29, 2005
• Study Start: October 1, 2001
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: August 26, 2008

Record last verified: 2008-08

Locations

PA (1)