NCT00669929

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

Enrollment Period

1.1 years

First QC Date

April 29, 2008

Last Update Submit

February 18, 2009

Conditions

GastroenteritisRotavirus VaccinesCost-Effectiveness

Keywords

Cost effectiveness analysis of rotavirus vaccination

Outcome Measures

Primary Outcomes (1)

  • patients' cost

    one year

Study Arms (3)

1

patients visited to Severance hospital

2

patients visited to Youngdong Severance hospital

3

patients visited to Wonju Christian hospital

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

patients to visit assigned hospital

You may qualify if:

  • children aged under 5 years and diagnosed as acute gastroenteritis

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wonju Christian Hospital

Wŏnju, Gangwon-do, South Korea

RECRUITING

Yonsei University Health System Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Youngdong Severance Hospital

Seoul, South Korea

RECRUITING

Related 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. doi: 10.1128/JCM.01505-07. Epub 2007 Aug 29.

    PMID: 17728473BACKGROUND

  • 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.

    PMID: 18174862BACKGROUND

  • 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.

    PMID: 17173677BACKGROUND

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Dong Soo Kim, MD, PhD

    professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Soo Kim, MD, PhD

CONTACT

82-2-2228-2005dskim6634@yuhs.ac

Ki Hwan Kim, MD

CONTACT

82-2-2227-4188khkim99@yuhs.ac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 1, 2008

Study Start

May 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 19, 2009

Record last verified: 2009-02

Locations

KR(3)