An observational study in Rotavirus Gastroenteritis, sponsored by Lifespan. Completed at 1 site in United States. Open to participants aged 2 Months to 5 Years. Per ClinicalTrials.gov, last updated 2019-11-14.
Sponsored by Lifespan · Observational
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.
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.
243 studies on the registry are indexed under Gastroenteritis; 15 are open to participants now.
This study's enrollment of 803 is above the median of 611 across 71 observational studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →Lifespan is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Residents of Rhode Island
Exclusion Criteria:
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.
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.
Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations
Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions
Time frame: 2007-2009
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
Time frame: 2007-2009
Risk factors for non-receipt of rotavirus vaccine
Identification of risk factors for non-receipt of rotavirus vaccine
Time frame: 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
Time frame: 2002-2009
Assess rotavirus vaccine coverage
Assess rotavirus vaccine coverage in Rhode Island
Time frame: 2007-2009
Plan to share: No — There is no plan to share IPD since the study uses a deidentified dataset and deidentified stool specimens for serotype analysis
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Lifespan