Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam

NCT00131820 | Completed Phase 4

• 1 other identifier: T-14
• Study Type: interventional
• Target: 100,742
• Locations: 1 country
• Sites: 1

Brief Summary

This study is part of International Vaccine Institutes (IVI)'s typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries. The primary objectives of the study are to evaluate the logistic feasibility of a mass typhoid fever immunization campaign program targeting school age children in Hue City, Vietnam and to assess the knowledge, attitudes, beliefs, and practices of parents and healthcare providers in Hue City regarding typhoid fever prevention and treatment.

Conditions

Typhoid; Paratyphoid Fever

Keywords

Salmonella; typhoid vaccine; enteric fever; socioeconomic costs

Outcome Measures

Primary Outcomes (2)

• Logistic feasibility of mass typhoid immunization campaign

• Knowledge attitudes, beliefs and practices of parents and health care providers on typhoid fever prevention and treatment

Secondary Outcomes (4)

• Cost-effectiveness of vaccine

• Vaccine effectiveness

• Adverse events

• Typhoid risk factors

Interventions

Typhoid Vi vaccine BIOLOGICAL

Hepatitis A (control) BIOLOGICAL

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Local students whose parents/guardians provide written consent to receive Vi vaccine
• Attending any of the 66 registered schools in Hue
• Registered in the project census
• Lives in Hue City

You may not qualify if:

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

Sponsors & Collaborators

• International Vaccine Institute: lead
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator
• Hue Preventive Medicine Center, Vietnam: collaborator
• Wellcome Trust: collaborator
• University of Western Ontario, Canada: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

National Institute of Hygiene and Epidemiology

Hanoi, Vietnam

Location

Related Publications (1)

• 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

Interventions

Vi polysaccharide vaccine, typhoid; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Salmonella Infections; 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

• Canh G Do, MD

  National Institute of Hygiene and Epidemiology, Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2005
• First Posted: August 19, 2005
• Study Start: December 1, 2001
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: March 13, 2008

Record last verified: 2008-03

Locations

VN (1)