Clinical trial NCT00131820: Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam
Official title: Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam. An Evaluation of Feasibility, Public Acceptability, Effectiveness and Cost-Effectiveness in Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Typhoid
Paratyphoid Fever
Keywords: Salmonella
typhoid vaccine
enteric fever
socioeconomic costs
Lead sponsor: International Vaccine Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Hygiene and Epidemiology, Vietnam
name: Hue Preventive Medicine Center, Vietnam
name: Wellcome Trust
name: University of Western Ontario, Canada
name: GlaxoSmithKline
First posted: 2005-08-19
Enrollment: 100742
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 logistic feasibility of providing Vi vaccine under actual programmatic conditions among school students in Hue City. The vaccines used in this study are internationally produced and locally licensed.

Secondary objectives of this trial are:

* To estimate the cost-effectiveness (cost of illness, willingness to pay, vaccine delivery costs, private vaccine costs, etc) of Vi vaccination
* To determine the effectiveness of the Vi polysaccharide vaccine following routine administration of a 1-dose schedule to school students (aged \>=6 years)
* To determine the safety and immunogenicity of the Vi vaccine
* To study typhoid risk factors among students

A nested, prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in Hue City.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Logistic feasibility of mass typhoid immunization campaign
measure: Knowledge attitudes, beliefs and practices of parents and health care providers on typhoid fever prevention and treatment
Secondary outcomes:
measure: Cost-effectiveness of vaccine
measure: Vaccine effectiveness
measure: Adverse events
measure: Typhoid risk factors
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Institute of Hygiene and Epidemiology
Study officials:
affiliation: National Institute of Hygiene and Epidemiology, Vietnam
name: Canh G Do, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.