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Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis

This study is not yet open for participant recruitment.
Verified November 2012 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01733862
First received: November 21, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

This study aims at assessing the impact of RV vaccination in hospitals in Nagoya City (administrative district), Japan, where RV vaccines have been introduced since November 2011 and financial support for vaccination costs by Nagoya city, Japan have been implemented from October 2012.


Condition Intervention
Rotavirus Gastroenteritis
 Other: Data collection

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: A Study to Assess the Impact of Rotavirus Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis (RV GE) in Japan

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
  • Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of RV GE hospitalizations by age group in children less than five years of age. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
  • Occurrence of AGE hospitalizations among all hospitalized children aged less than five years. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
  • Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
  • Occurrence of outpatient visits for RV GE among all outpatient visits in children less than five years of age. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
  • Occurrence of outpatient visits for RV GE among AGE outpatient visits in children less than five years of age. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
  • Duration of hospitalizations for RV GE or AGE, overall, for each year, season in children less than five years of age. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
  • Occurrence of hospitalizations for RV GE among all emergency visits for RV GE in children less than five years of age. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group Japan
Children less than five years of age, hospitalized for RV GE or AGE and children with outpatient or emergency room visits for RV GE or AGE, between November 2009 and October 2014 (i.e., before and after the introduction of RV vaccination in Japan) in any of the selected hospitals.
 Other: Data collection
Data sheet.

Detailed Description:

The electronic admission database or any other applicable database of the hospital will be reviewed to identify hospitalized children/children with outpatient visits/emergency room visits, less than five years of age who had been diagnosed with acute gastroenteritis (AGE) or RV GE either by the International Classification of Diseases and Related Health Problems 10th Revision (ICD 10) diagnostic code (AA00-AA09 for intestinal infectious diseases and A08.0 for RV specific GE) or by RV positive rapid diagnosis kit results.

Note: The outcomes for the outpatient and emergency room visits will be assessed only in case the data for outpatient and emergency room visits can be obtained from at least one of the study centers.

  Eligibility

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

Children less than five years of age, hospitalized for RV GE or AGE and children with outpatient or emergency room visits for RV GE or AGE, between November 2009 and October 2014 (i.e., before and after the introduction of RV vaccination in Japan) in any of the selected hospitals.

Criteria

Inclusion Criteria:

- Children aged less than five years visiting hospitals for RV GE or AGE from 2009 to 2014, who live in the study area.

Exclusion Criteria:

- Not applicable.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733862

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01733862     History of Changes
Other Study ID Numbers: 116929
Study First Received: November 21, 2012
Last Updated: November 28, 2012
Health Authority: Japan: MHLW (Ministry of Health, Labour and Welfare)

Keywords provided by GlaxoSmithKline:
Impact
Vaccination
Hospitalizations
Rotavirus gastroenteritis
Japan

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013