Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island



Status:Active, not recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any - 5
Updated:4/21/2016
Start Date:July 2009
End Date:October 2016

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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.

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.

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
We found this trial at
1
site
Providence, Rhode Island 02903
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mi
from
Providence, RI
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