Cost-Effectiveness Analysis of Rotavirus Vaccination for Children in Korea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Severance Hospital
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00669929
First received: April 29, 2008
Last updated: February 18, 2009
Last verified: February 2009
  Purpose

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.


Condition
Gastroenteritis
Rotavirus Vaccines
Cost-Effectiveness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cost-Effectiveness Analysis of Rotavirus Vaccination for Children in Korea

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • patients' cost [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients visited to Severance hospital
2
patients visited to Youngdong Severance hospital
3
patients visited to Wonju Christian hospital

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

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients to visit assigned hospital

Criteria

Inclusion Criteria:

  • children aged under 5 years and diagnosed as acute gastroenteritis

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669929

Contacts
Contact: Dong Soo Kim, MD, PhD 82-2-2228-2005 dskim6634@yuhs.ac
Contact: Ki Hwan Kim, MD 82-2-2227-4188 khkim99@yuhs.ac

Locations
Korea, Republic of
Wonju Christian Hospital Recruiting
Wonju, Kangwon-do, Korea, Republic of
Contact: Hwang Min Kim, MD,PhD       khm9120@wonju.yonsei.ac.kr   
Sub-Investigator: Hwang Min Kim, MD,PhD         
Yonsei University Health System Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Dong Soo Kim, MD, PhD    82-2-2228-2005    dskim6634@yuhs.ac   
Contact: Ki Hwan Kim, MD    82-2-2227-4188    khkim99@yuhs.ac   
Principal Investigator: Dong Soo Kim, MD, PhD         
Sub-Investigator: Hye-Young Kang, PhD         
Sub-Investigator: Ki Hwan Kim, MD         
Youngdong Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ji Hong Kim, MD,PhD       kkkjhd@yuhs.ac   
Sub-Investigator: Ji Hong Kim, MD,PhD         
Sponsors and Collaborators
Yonsei University
Merck Sharp & Dohme Corp.
Severance Hospital
Investigators
Principal Investigator: Dong Soo Kim, MD, PhD professor
  More Information

Publications:
Responsible Party: Yonsei University Health System Severance Hospital, Yonsei University
ClinicalTrials.gov Identifier: NCT00669929     History of Changes
Other Study ID Numbers: rota-001, yonsei-rota
Study First Received: April 29, 2008
Last Updated: February 18, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Cost effectiveness analysis of rotavirus vaccination

Additional relevant MeSH terms:
Gastroenteritis
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 30, 2014