Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island: Active Hospital-Based Surveillance, Serotype Surveillance and a Case-Control Study

Conditions
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Rotavirus Gastroenteritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: rotavirus gastroenteritis requiring hospitalization immunocompetent born after April 15, 2006 greater than 2 months of age on the day of admission Exclusion Criteria: rotavirus vaccine contraindicated for that child based on ACIP/AAP recommendations an immunization record cannot be obtained through the KIDSNET database

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases of rotavirus gastroenteritis<br>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<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations | Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions | 2007-2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2007-2009 | 
| Risk factors for non-receipt of rotavirus vaccine | Identification of risk factors for non-receipt of rotavirus vaccine | 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 | 2002-2009 | 
| Assess rotavirus vaccine coverage | Assess rotavirus vaccine coverage in Rhode Island | 2007-2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotavirus, gastroenteritis, vaccine, case-control study, serotype