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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01733862
First received: November 21, 2012
Last updated: February 4, 2016
Last verified: February 2016
  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
Infections, Rotavirus
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:


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: From Nov 2007 to Oct 2016 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age. [ Time Frame: From Nov 2007 to Oct 2016 ] [ Designated as safety issue: No ]
  • Occurrence of RV GE hospitalizations by age group in children less than five years of age. [ Time Frame: From Nov 2007 to Oct 2016 ] [ Designated as safety issue: No ]
  • Occurrence of AGE hospitalizations among all hospitalized children aged less than five years. [ Time Frame: From Nov 2007 to Oct 2016 ] [ 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: From Nov 2007 to Oct 2016 ] [ 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: From Nov 2007 to Oct 2016 ] [ 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: From Nov 2007 to Oct 2016 ] [ 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: From Nov 2007 to Oct 2016 ] [ 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: From Nov 2007 to Oct 2016 ] [ Designated as safety issue: No ]

Estimated Enrollment: 13500
Study Start Date: November 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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 2007 and October 2016 (i.e., before and after the introduction of RV vaccination in Japan) in any of the selected hospitals.
Other: Data collection

Data sheet. Data will be collected and is planned to be analysed at the following time points:

Pre-vaccination period: Nov 2007 to Oct 2011, transition period: Nov 2011 to Oct 2012 and post vaccination period: Nov 2012 to Oct 2016.


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 1824 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include 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 2007 and October 2016 (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 2007 to 2016, who live in the study area.

Exclusion Criteria:

- Not applicable.

  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: NCT01733862

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

Locations
Japan
GSK Investigational Site Recruiting
Aichi, Japan, 457-8510
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Aichi, Japan, 457-8511
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Aichi, Japan, 466-8650
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Aichi, Japan, 468-8520
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    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: February 4, 2016
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
Rotavirus Infections
Digestive System Diseases
Gastrointestinal Diseases
RNA Virus Infections
Reoviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 08, 2016