Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China

NCT00131833 | Completed Phase 4

• 1 other identifier: T3
• Study Type: interventional
• Target: 96,468
• Locations: 1 country
• Sites: 1

Brief Summary

This study is part of International Vaccine Institute (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 Hechi City in the Guangxhi province of China. The cost-effectiveness and safety of Vi vaccination will also be evaluated.

Conditions

Typhoid; Paratyphoid Fever

Keywords

salmonella; typhoid vaccine; enteric fever

Outcome Measures

Primary Outcomes (3)

• vaccine effectiveness

• cost effectiveness of typhoid Vi immunization

• adverse events

Secondary Outcomes (4)

• logistic feasibility of mass typhoid immunization

• anti-Vi antibody response

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

• Typhoid risk factors

Interventions

Typhoid Vi vaccine BIOLOGICAL

Meningococcal A (control) BIOLOGICAL

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Registered in the project census

You may not qualify if:

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

Sponsors & Collaborators

• International Vaccine Institute: lead
• Centers for Disease Control and Prevention: collaborator
• Hechi City Center for Disease Centrol: collaborator
• Wellcome Trust: collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (1)

Hechi City Center for Disease Control

Hechi, Guangxi, 54700, China

Location

Related Publications (3)

• Dong BQ, Yang J, Tang ZZ, Yang HH, Zeng J, Zhang J, Wang ML, Liang GC, Si GA, Li CY, Liang DB, Liao HZ, Ochiai RL, Mohammad A, Acosta CJ, Clemens J. [Application of cluster randomization method on typhoid Vi vaccine trails]. Zhonghua Liu Xing Bing Xue Za Zhi. 2005 Feb;26(2):97-100. Chinese.

  PMID: 15921608 BACKGROUND

• Yang J, Acosta CJ, Si GA, Zeng J, Li CY, Liang DB, Ochiai RL, Page AL, Danovaro-Holliday MC, Zhang J, Zhou BD, Liao HZ, Wang ML, Tan DM, Tang ZZ, Gong J, Park JK, Ali M, Ivanoff B, Liang GC, Yang HH, Pang T, Xu ZY, Donner A, Galindo CM, Dong BQ, Clemens JD. A mass vaccination campaign targeting adults and children to prevent typhoid fever in Hechi; expanding the use of Vi polysaccharide vaccine in southeast China: a cluster-randomized trial. BMC Public Health. 2005 May 18;5:49. doi: 10.1186/1471-2458-5-49.

  PMID: 15904514 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

Interventions

Vi polysaccharide vaccine, typhoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Dong Baiqing, MD

  Guangxi Center for Disease Control and Prevention

  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: October 1, 2001
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: March 13, 2008

Record last verified: 2008-03

Locations

CN (1)