Cost-Effectiveness Analysis of Rotavirus Vaccination for Children in Korea

Gastroenteritis Clinical Trial

Official title:

Cost-Effectiveness Analysis of Rotavirus Vaccination for Children in Korea

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00669929
• Other study ID #: rota-001
• Secondary ID: yonsei-rota
• Status: Unknown status
• Phase: N/A
• First received: April 29, 2008
• Last updated: February 18, 2009
• Start date: May 2008
• Est. completion date: June 2009

Study information

• Verified date: February 2009
• Source: Yonsei University
• Contact: Dong Soo Kim, MD, PhD
• Phone: 82-2-2228-2005
• Email: dskim6634[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 200
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• children aged under 5 years and diagnosed as acute gastroenteritis

Exclusion Criteria:

Related Conditions & MeSH terms

• Cost-Effectiveness
• Gastroenteritis
• Rotavirus Vaccines

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System Severance Hospital	Seoul
Korea, Republic of	Youngdong Severance Hospital	Seoul
Korea, Republic of	Wonju Christian Hospital	Wonju	Kangwon-do

Sponsors (3)

Lead Sponsor	Collaborator
Yonsei University	Merck Sharp & Dohme Corp., Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. Epub 2007 Aug 29. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients' cost		one year