Clinical trial NCT01733862: Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis
Official title: A Study to Assess the Impact of Rotavirus Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis (RV GE) in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Rotavirus Vaccines
Keywords: Impact
Vaccination
Hospitalizations
Rotavirus gastroenteritis
Japan
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 5394
Sex: ALL
Maximum age (years): 1824
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.
timeFrame: From Nov 2007 to Oct 2016
Secondary outcomes:
measure: Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.
timeFrame: From Nov 2007 to Oct 2016
measure: Occurrence of RV GE hospitalizations by age group in children less than five years of age.
timeFrame: From Nov 2007 to Oct 2016
measure: Occurrence of AGE hospitalizations among all hospitalized children aged less than five years.
timeFrame: From Nov 2007 to Oct 2016
measure: Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age.
timeFrame: From Nov 2007 to Oct 2016
measure: Occurrence of outpatient visits for RV GE among all outpatient visits in children less than five years of age.
timeFrame: From Nov 2007 to Oct 2016
measure: Occurrence of outpatient visits for RV GE among AGE outpatient visits in children less than five years of age.
timeFrame: From Nov 2007 to Oct 2016
measure: Duration of hospitalizations for RV GE or AGE, overall, for each year, season in children less than five years of age.
timeFrame: From Nov 2007 to Oct 2016
measure: Occurrence of hospitalizations for RV GE among all emergency visits for RV GE in children less than five years of age.
timeFrame: From Nov 2007 to Oct 2016
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Yoshikawa T, Matsuki T, Sato K, Mizuno M, Shibata M, Hasegawa S, Morita M, Iwasa M, Gopala K, Holl K. Impact of rotavirus vaccination on the burden of acute gastroenteritis in Nagoya city, Japan. Vaccine. 2018 Jan 25;36(4):527-534. doi: 10.1016/j.vaccine.2017.12.006. Epub 2017 Dec 13.