Clinical trial NCT00669929: Cost-Effectiveness Analysis of Rotavirus Vaccination for Children in Korea
Official title: Cost-Effectiveness Analysis of Rotavirus Vaccination for Children in Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroenteritis
Rotavirus Vaccines
Cost-Effectiveness
Keywords: Cost effectiveness analysis of rotavirus vaccination
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Severance Hospital
First posted: 2008-05-01
Enrollment: 200
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients to visit assigned hospital

Brief summary: The primary objective of the proposed project is to estimate the economic impact of a national rotavirus immunization program in preventing rotavirus diarrhea among Korean children.

Detailed description: Rotavirus is the leading cause of severe acute diarrhea or gastroenteritis among young children worldwide. In the first 5 years of life, about 90% of children experience at least one episode of rotavirus infection.Each year, rotavirus diarrhea is responsible for 440,000 deaths, 2 million hospitalizations, and 25 million outpatient visits among children younger than 5 years worldwide. In South Korea, rotavirus diarrhea rarely causes mortality, but it cause significant morbidity. A recent population-based study in Korea has estimated that the annual incidence of rotavirus diarrhea accounts for 56.9 cases per 1,000 children less than 5 years old. Oral, live pentavalent human-bovine reassortant rotavirus vaccine has been developed and licensed for the use of preventing rotavirus disease in many countries. Yet, there has been no research done to assess the impact of national rotavirus immunization program in Korea. It is expected that systematic appraisal on the national burden of rotavirus infection and potential public health and economic benefits of rotavirus vaccination for children in Korea will assists health policy makers to set a priority for the prevention of this disease.

Eligibility criteria: Inclusion Criteria:

* children aged under 5 years and diagnosed as acute gastroenteritis

Exclusion Criteria:

* none

Primary outcomes:
measure: patients' cost
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
state: Kangwon-do
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Youngdong Severance Hospital
Study officials:
affiliation: professor
name: Dong Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong SK, Lee SG, Lee SA, Kang JH, Lee JH, Kim JH, Kim DS, Kim HM, Jang YT, Ma SH, Kim SY, Paik SY. Characterization of a G11,P[4] strain of human rotavirus isolated in South Korea. J Clin Microbiol. 2007 Nov;45(11):3759-61. doi: 10.1128/JCM.01505-07. Epub 2007 Aug 29.
citation: Kim DS, Lee TJ, Kang JH, Kim JH, Lee JH, Ma SH, Kim SY, Kim HM, Shin SM. Immunogenicity and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy infants in Korea. Pediatr Infect Dis J. 2008 Feb;27(2):177-8. doi: 10.1097/INF.0b013e31815aba79.
citation: Lu CY, Lauderdale TL, Fang YH, Wang CY, Ho YH, Hung CL, Chang LY, Lee CY, Huang LM. Disease burden and related medical costs of rotavirus infections in Taiwan. BMC Infect Dis. 2006 Dec 15;6:176. doi: 10.1186/1471-2334-6-176.