NCT01733862

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,394

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

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

November 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

November 27, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2017

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

4.2 years

First QC Date

November 21, 2012

Last Update Submit

May 29, 2019

Conditions

Infections, RotavirusRotavirus Vaccines

Keywords

ImpactVaccinationHospitalizationsRotavirus gastroenteritisJapan

Outcome Measures

Primary Outcomes (1)

  • Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.

    From Nov 2007 to Oct 2016

Secondary Outcomes (8)

  • Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.

    From Nov 2007 to Oct 2016

  • Occurrence of RV GE hospitalizations by age group in children less than five years of age.

    From Nov 2007 to Oct 2016

  • Occurrence of AGE hospitalizations among all hospitalized children aged less than five years.

    From Nov 2007 to Oct 2016

  • Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age.

    From Nov 2007 to Oct 2016

  • Occurrence of outpatient visits for RV GE among all outpatient visits in children less than five years of age.

    From Nov 2007 to Oct 2016

  • +3 more secondary outcomes

Study Arms (1)

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

Interventions

Data collectionOTHER

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.

Group Japan

Eligibility Criteria

AgeUp to 1824 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • \- Children aged less than five years visiting hospitals for RV GE or AGE from 2007 to 2016, who live in the study area.

You may not qualify if:

  • \- Not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

GSK Investigational Site

Aichi, 457-8510, Japan

Location

GSK Investigational Site

Aichi, 457-8511, Japan

Location

GSK Investigational Site

Aichi, 457-85, Japan

Location

GSK Investigational Site

Aichi, 466-8650, Japan

Location

GSK Investigational Site

Aichi, 466-86, Japan

Location

GSK Investigational Site

Aichi, 468-8520, Japan

Location

GSK Investigational Site

Aichi, 468-85, Japan

Location

Related Publications (1)

  • 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.

    PMID: 29248263BACKGROUND

Related Links

MeSH Terms

Conditions

Rotavirus InfectionsTooth, Impacted

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

  • GSK Clinical Trials

    GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 27, 2012

Study Start

November 27, 2012

Primary Completion

February 8, 2017

Study Completion

February 8, 2017

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

JP(7)