Clinical Trials Logo

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
Health authority
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:

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01168401 - Bivalent Norovirus Vaccine Study Phase 1
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Completed NCT02473887 - Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting Phase 1
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Not yet recruiting NCT01671137 - Probiotic for the Prevention of Functional Disorders in Childhood N/A
Completed NCT01917461 - Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections N/A
Withdrawn NCT00691275 - Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration N/A
Recruiting NCT06025695 - Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks Phase 3
Completed NCT04463082 - Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound N/A
Completed NCT02497417 - A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients N/A
Active, not recruiting NCT03000296 - Autologous Unselected Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease N/A
Completed NCT01236066 - Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia N/A
Completed NCT01225042 - The Effect of Probiotics on E. Coli Gastroenteritis N/A
Recruiting NCT00987519 - Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age N/A
Terminated NCT01357174 - ROTATEQâ„¢ Post-Marketing Surveillance in the Philippines N/A
Completed NCT01033799 - Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers N/A
Recruiting NCT01363726 - Surveillance of Rotavirus Gastroenteritis in Children <5 Years N/A
Completed NCT00130832 - Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED) Phase 3
Terminated NCT02568189 - Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration N/A
Terminated NCT02165813 - Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children Phase 2/Phase 3