Infections, RotavirusNCT01733862
Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis
An observational study of Infections, Rotavirus and Rotavirus Vaccines, run by GlaxoSmithKline at 7 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1824 days
- Conditions the study is for
- Infections, Rotavirus, Rotavirus Vaccines
- What is being tested?
- Data collection
- Type of treatment
- Vaccines
- How many people
- 5,394 participants
- Where
- 7 sitesJapan
- Study dates
- 27 Nov 2012to 8 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1824 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children aged less than five years visiting hospitals for RV GE or AGE from 2007 to 2016, who live in the study area.
Who cannot join
- Not applicable.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
GSK Investigational Site
Aichi, 457-8510
GSK Investigational Site
Aichi, 457-8511
GSK Investigational Site
Aichi, 457-85
GSK Investigational Site
Aichi, 466-8650
GSK Investigational Site
Aichi, 466-86
GSK Investigational Site
Aichi, 468-8520
GSK Investigational Site
Aichi, 468-85
About this study
Official title: A Study to Assess the Impact of Rotavirus Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis (RV GE) in Japan
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.
Read the 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.
- Conditions
- Infections, Rotavirus, Rotavirus Vaccines
- Being tested
- Data collection
- Keywords
- Impact, Vaccination, Hospitalizations, Rotavirus gastroenteritis, Japan
- Medical subject headings
- Rotavirus Infections, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.
Measured: 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.
Measured: From Nov 2007 to Oct 2016
Occurrence of RV GE hospitalizations by age group in children less than five years of age.
Measured: From Nov 2007 to Oct 2016
Occurrence of AGE hospitalizations among all hospitalized children aged less than five years.
Measured: From Nov 2007 to Oct 2016
Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age.
Measured: 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.
Measured: From Nov 2007 to Oct 2016
Occurrence of outpatient visits for RV GE among AGE outpatient visits in children less than five years of age.
Measured: From Nov 2007 to Oct 2016
Duration of hospitalizations for RV GE or AGE, overall, for each year, season in children less than five years of age.
Measured: From Nov 2007 to Oct 2016
Occurrence of hospitalizations for RV GE among all emergency visits for RV GE in children less than five years of age.
Measured: From Nov 2007 to Oct 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study start27 Nov 2012
- Primary completion8 Feb 2017
- Study completion8 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, RotavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 5,394 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733862
- Sponsor's protocol ID
- 116929
- Status last verified
- May 2019
- First submitted
- 21 Nov 2012
- Last updated
- 30 May 2019
- Results posted
- No
Publications
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.
PubMed 29248263
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Impact of Rotavirus Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis (RV GE) in Japan
- ClinicalTrials.gov ID
- NCT01733862
- Acronym / sponsor ID
- 116929
- Conditions
- Infections, Rotavirus, Rotavirus Vaccines
- Keywords
- Impact, Vaccination, Hospitalizations, Rotavirus gastroenteritis, Japan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,394 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2012 (actual)
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Japan | – | Other: Data collectionChildren 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. |
Who may qualify
- Ages
- Up to 1824 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Children aged less than five years visiting hospitals for RV GE or AGE from 2007 to 2016, who live in the study area.
Key exclusion criteria (1 listed)
- Not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionData 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. | Other | Group Japan |
Primary outcome
Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.
Time frame: From Nov 2007 to Oct 2016
8 secondary outcomes
Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.
Time frame: From Nov 2007 to Oct 2016
Occurrence of RV GE hospitalizations by age group in children less than five years of age.
Time frame: From Nov 2007 to Oct 2016
Occurrence of AGE hospitalizations among all hospitalized children aged less than five years.
Time frame: From Nov 2007 to Oct 2016
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Background: PubMed 29248263Yoshikawa 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.
- Results Summary, Full Protocol and Analysis Plan for study 116929 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Rotavirus and Rotavirus Vaccines, run by GlaxoSmithKline at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years. (time frame: From Nov 2007 to Oct 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01733862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.