Rotavirus GastroenteritisNCT01026779
Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island
An observational study of Rotavirus Gastroenteritis, run by Lifespan at 1 site in United States.
Trial summary
The goals of this study are to see what effects the introduction of RV5(RotaTeq) vaccine has had in the community both on the number of rotavirus-associated hospitalizations and on the strains of rotavirus circulating in the community. Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- Conditions the study is for
- Rotavirus Gastroenteritis
- How many people
- 803 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to 1 Nov 2019
- 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 2 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Residents of Rhode Island
Who may be able to join
- rotavirus gastroenteritis requiring hospitalization
- immunocompetent
- born after April 15, 2006
- greater than 2 months of age on the day of admission
Who cannot join
- rotavirus vaccine contraindicated for that child based on ACIP/AAP recommendations
- an immunization record cannot be obtained through the KIDSNET database
Trial locations and contacts
1 site in 1 country.
United States1 site
Hasbro Children's Hospital
Providence, Rhode Island, 02903
About this study
Official title: Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island: Active Hospital-Based Surveillance, Serotype Surveillance and a Case-Control Study
The goals of this study are to see what effects the introduction of RV5(RotaTeq) vaccine has had in the community both on the number of rotavirus-associated hospitalizations and on the strains of rotavirus circulating in the community. The investigators will use cases of rotavirus gastroenteritis identified on the wards at Hasbro Children's Hospital during the 2007-2009 rotavirus seasons for a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations. The investigators plan to assess rotavirus vaccine coverage in Rhode Island using the state vaccine registry and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island. Finally using the state child health database, KIDSNET the investigators plan to investigate the reasons that children may not have received rotavirus vaccine in order to better target educational efforts for parents and health care providers.
Read the detailed description
The goals of this study, conducted after the introduction of RV5 (RotaTeq) vaccine in the community, are: 1) to use a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions, 2) to assess rotavirus vaccine coverage and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island and 3) to investigate risk factors for non-receipt of rotavirus vaccine to inform educational efforts for parents and providers, and 4) to characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine to determine if serotype replacement is occurring.
- Conditions
- Rotavirus Gastroenteritis
- Keywords
- rotavirus, gastroenteritis, vaccine, case-control study, serotype
- Medical subject headings
- Gastroenteritis
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 |
|---|---|---|
| Cases of rotavirus gastroenteritis | Patients will be eligible as cases if they have been identified by the investigator's ongoing rotavirus surveillance studies as having been hospitalized with laboratory-confirmed rotavirus gastroenteritis between January 1, 2007 and June 31, 2009. To be eligible as a case, the child must meet the following criteria: 1) immunocompetent; 2) born after April 15, 2006 (to select a population that would have been in the age group eligible for at least 1 dose of RV5 (RotaTeq); and 3) > 2 months of age on the day of admission. | |
| Control Subjects | Three controls for each case will be identified using KIDSNET, the state child health registry. Controls will be matched to cases by age and county of residence at birth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations
Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions
Measured: 2007-2009
Secondary outcomes (4)
Vaccine use outside the recommended age limits
The extent to which rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island
Measured: 2007-2009
Risk factors for non-receipt of rotavirus vaccine
Identification of risk factors for non-receipt of rotavirus vaccine
Measured: 2007-2009
Characterize the strains of rotavirus circulating in the community
Characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine
Measured: 2002-2009
Assess rotavirus vaccine coverage
Assess rotavirus vaccine coverage in Rhode Island
Measured: 2007-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startJul 2009
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus GastroenteritisStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Penelope H. Dennehy, Lifespan
- Investigators
- Penelope H Dennehy, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026779
- Sponsor's protocol ID
- HCH-001
- Status last verified
- Nov 2019
- First submitted
- 2 Dec 2009
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD since the study uses a deidentified dataset and deidentified stool specimens for serotype analysis
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island: Active Hospital-Based Surveillance, Serotype Surveillance and a Case-Control Study
- ClinicalTrials.gov ID
- NCT01026779
- Acronym / sponsor ID
- HCH-001
- Conditions
- Rotavirus Gastroenteritis
- Keywords
- rotavirus, gastroenteritis, vaccine, case-control study, serotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- LifespanUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2009 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 4 Dec 2009 (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.
The goals of this study are to see what effects the introduction of RV5(RotaTeq) vaccine has had in the community both on the number of rotavirus-associated hospitalizations and on the strains of rotavirus circulating in the community. The investigators will use cases of rotavirus gastroenteritis identified on the wards at Hasbro Children's Hospital during the 2007-2009 rotavirus seasons for a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations. The investigators plan to assess rotavirus vaccine coverage in Rhode Island using the state vaccine registry and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island. Finally using the state child health database, KIDSNET the investigators plan to investigate the reasons that children may not have received rotavirus vaccine in order to better target educational efforts for parents and health care providers.
Detailed description
The goals of this study, conducted after the introduction of RV5 (RotaTeq) vaccine in the community, are: 1) to use a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions, 2) to assess rotavirus vaccine coverage and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island and 3) to investigate risk factors for non-receipt of rotavirus vaccine to inform educational efforts for parents and providers, and 4) to characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine to determine if serotype replacement is occurring.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases of rotavirus gastroenteritis | – | –Patients will be eligible as cases if they have been identified by the investigator's ongoing rotavirus surveillance studies as having been hospitalized with laboratory-confirmed rotavirus gastroenteritis between January 1, 2007 and June 31, 2009. To be eligible as a case, the child must meet the following criteria: 1) immunocompetent; 2) born after April 15, 2006 (to select a population that would have been in the age group eligible for at least 1 dose of RV5 (RotaTeq); and 3) > 2 months of age on the day of admission. |
| Control Subjects | – | –Three controls for each case will be identified using KIDSNET, the state child health registry. Controls will be matched to cases by age and county of residence at birth. |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Residents of Rhode Island
Key inclusion criteria (4 listed)
- rotavirus gastroenteritis requiring hospitalization
- immunocompetent
- born after April 15, 2006
- greater than 2 months of age on the day of admission
Key exclusion criteria (2 listed)
- rotavirus vaccine contraindicated for that child based on ACIP/AAP recommendations
- an immunization record cannot be obtained through the KIDSNET database
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
Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations
Time frame: 2007-2009
Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions
4 secondary outcomes
Vaccine use outside the recommended age limits
Time frame: 2007-2009
Risk factors for non-receipt of rotavirus vaccine
Time frame: 2007-2009
Characterize the strains of rotavirus circulating in the community
Time frame: 2002-2009
Assess rotavirus vaccine coverage
Time frame: 2007-2009
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 14 Nov 2019.
- Individual participant dataSharing planned: No. There is no plan to share IPD since the study uses a deidentified dataset and deidentified stool specimens for serotype analysis
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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.
Penelope H Dennehy, MD principal investigator
Rhode Island Hospital
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 Gastroenteritis, run by Lifespan at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 14 Nov 2019. 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 United States. 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?
Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations (time frame: 2007-2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2019.