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Cost-Effectiveness Analysis of Rotavirus Vaccination for Children in Korea

NCT ID: NCT00669929

Last Updated: 2009-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastroenteritis Rotavirus Vaccines Cost-Effectiveness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

patients visited to Severance hospital

No interventions assigned to this group

2

patients visited to Youngdong Severance hospital

No interventions assigned to this group

3

patients visited to Wonju Christian hospital

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* children aged under 5 years and diagnosed as acute gastroenteritis

Exclusion Criteria

* none
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Yonsei University

Principal Investigators

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Dong Soo Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

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Wonju Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status RECRUITING

Yonsei University Health System Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Youngdong Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Soo Kim, MD, PhD

Role: CONTACT

[email protected]
82-2-2228-2005

Ki Hwan Kim, MD

Role: CONTACT

[email protected]
82-2-2227-4188

Facility Contacts

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Hwang Min Kim, MD,PhD

Role: primary

[email protected]

Dong Soo Kim, MD, PhD

Role: primary

[email protected]
82-2-2228-2005

Ki Hwan Kim, MD

Role: backup

[email protected]
82-2-2227-4188

Ji Hong Kim, MD,PhD

Role: primary

[email protected]

References

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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.

Reference Type BACKGROUND
PMID: 17728473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18174862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17173677 (View on PubMed)

Other Identifiers

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yonsei-rota

Identifier Type: -

Identifier Source: secondary_id

rota-001

Identifier Type: -

Identifier Source: org_study_id

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