Rotavirus InfectionERVSNCT02662543
The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children After Introduction of Rotavirus Vaccines
An observational study of Rotavirus Infection, run by University of Tartu at 1 site in Estonia.
Trial summary
This study is designed to estimate the changes in the etiology and epidemiology of acute gastroenteritis in children aged less than 18 years after the implementation of rotavirus vaccine in the Estonian national immunization program in July 2014. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Rotavirus Infection
- How many people
- 2,260 participants
- Where
- 1 siteEstonia
- Study dates
- Feb 2015to Aug 2020
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children less than 18-years-old hospitalized due to acute gastroenteritis to seven Estonian hospitals participating in this study from 02.2015-09.2016
Who may be able to join
- children aged < 18 year
- hospitalized due to acute gastroenteritis
Who cannot join
- children aged > 18 years
- gastroenteritis due to known non-infectious causes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children Aged < 18 Years After Introduction of Rotavirus Vaccines
This study is designed to estimate the changes in the etiology and epidemiology of acute gastroenteritis in children aged less than 18 years after the implementation of rotavirus vaccine in the Estonian national immunization program in July 2014.
Read the detailed description
The two-year study period started in February 2015.
The study population consists of all children less than 18-years-old hospitalized due to acute gastroenteritis (AGE) to seven Estonian hospitals participating in this study. Expected sample size is about 2000 patients.
Hospitals that participate in this study are Tartu University Hospital, West-Tallinn Central Hospital, Tallinn's Children Hospital, Pärnu Central Hospital, South-Estonian Hospital, Kuressaare Hospital and Ida-Viru Central Hospital.
Before enrollment all patients are asked to give an informed consent. After enrollment the study doctor completes electronic questionnaire regarding the patients demographic data, medical history and vaccinations. Specific database for our study has been created by company Vision 5D. After completing electronic questionnaire the doctor collects 2 stool samples each 2 ml of volume into Eppendorf tubes produced by our study laboratory. The samples are transported to our study laboratory where they are tested for rotavirus, norovirus G1, G2, astrovirus, adenovirus and sapovirus with Fast-Track Diagnostics real-time assay kit FTD Viral Gastroenteritis. The samples positive for rotavirus are refrigerated at -70 degrees for further genotyping and sequencing.
- Conditions
- Rotavirus Infection
- Keywords
- rotavirus,, acute gastroenteritis, vaccination, Estonia, impact, severity scales
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized AGE patients | Children less than 18-years-old hospitalized due to acute gastroenteritis to seven Estonian hospitals participating in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis
Evaluate the impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis
Measured: up to 2 years
Secondary outcomes (1)
The severity of disease according to Vesikari and Clark severity scales
Measure the severity of disease according to Vesikari and Clark severity scales
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startFeb 2015
- Primary completionAug 2018 (estimated)
- Study completionAug 2020 (estimated)
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 Rotavirus InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadri Kõivumägi, University of Tartu
- Investigators
- Irja Lutsar, PhD, Study chair, Institute of Microbiology, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662543
- Sponsor's protocol ID
- 224/T-3
- Acronym
- ERVS
- Status last verified
- Dec 2016
- First submitted
- 14 Jan 2016
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Koivumagi K, Soeorg H, Toompere K, Kallas E, Joegeda EL, Lass E, Huik K, Lutsar I; RV Study group. Rotavirus Strain Surveillance in Estonia After Introduction of Rotavirus Universal Mass Vaccination. Pediatr Infect Dis J. 2021 May 1;40(5):489-494. doi: 10.1097/INF.0000000000003039.
PubMed 33847298
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children Aged < 18 Years After Introduction of Rotavirus Vaccines
- ClinicalTrials.gov ID
- NCT02662543
- Acronym / sponsor ID
- ERVS / 224/T-3
- Conditions
- Rotavirus Infection
- Keywords
- rotavirus,, acute gastroenteritis, vaccination, Estonia, impact, severity scales
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,260 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 25 Jan 2016 (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 is designed to estimate the changes in the etiology and epidemiology of acute gastroenteritis in children aged less than 18 years after the implementation of rotavirus vaccine in the Estonian national immunization program in July 2014.
Detailed description
The two-year study period started in February 2015.
The study population consists of all children less than 18-years-old hospitalized due to acute gastroenteritis (AGE) to seven Estonian hospitals participating in this study. Expected sample size is about 2000 patients.
Hospitals that participate in this study are Tartu University Hospital, West-Tallinn Central Hospital, Tallinn's Children Hospital, Pärnu Central Hospital, South-Estonian Hospital, Kuressaare Hospital and Ida-Viru Central Hospital.
Before enrollment all patients are asked to give an informed consent. After enrollment the study doctor completes electronic questionnaire regarding the patients demographic data, medical history and vaccinations. Specific database for our study has been created by company Vision 5D. After completing electronic questionnaire the doctor collects 2 stool samples each 2 ml of volume into Eppendorf tubes produced by our study laboratory. The samples are transported to our study laboratory where they are tested for rotavirus, norovirus G1, G2, astrovirus, adenovirus and sapovirus with Fast-Track Diagnostics real-time assay kit FTD Viral Gastroenteritis. The samples positive for rotavirus are refrigerated at -70 degrees for further genotyping and sequencing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized AGE patients | – | –Children less than 18-years-old hospitalized due to acute gastroenteritis to seven Estonian hospitals participating in this study |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children less than 18-years-old hospitalized due to acute gastroenteritis to seven Estonian hospitals participating in this study from 02.2015-09.2016
Key inclusion criteria (2 listed)
- children aged < 18 year
- hospitalized due to acute gastroenteritis
Key exclusion criteria (2 listed)
- children aged > 18 years
- gastroenteritis due to known non-infectious causes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis
Time frame: up to 2 years
Evaluate the impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis
1 secondary outcome
The severity of disease according to Vesikari and Clark severity scales
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- Derived from this study: PubMed 33847298Koivumagi K, Soeorg H, Toompere K, Kallas E, Joegeda EL, Lass E, Huik K, Lutsar I; RV Study group. Rotavirus Strain Surveillance in Estonia After Introduction of Rotavirus Universal Mass Vaccination. Pediatr Infect Dis J. 2021 May 1;40(5):489-494. doi: 10.1097/INF.0000000000003039.
- Individual participant dataSharing planned: No
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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.
Irja Lutsar, PhD study chair
Institute of Microbiology, University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotavirus Infection, run by University of Tartu at 1 site in Estonia.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. 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?
Results are not available in the source record.
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?
The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis (time frame: up to 2 years). 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 NCT02662543, 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 21 Dec 2016.