Rotavirus Gastroenteritis
Conditions
Keywords
rotavirus, gastroenteritis, vaccine, case-control study, serotype
Brief 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. 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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Lifespan
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations | 2007-2009 | Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine use outside the recommended age limits | 2007-2009 | 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 |
| Risk factors for non-receipt of rotavirus vaccine | 2007-2009 | Identification of risk factors for non-receipt of rotavirus vaccine |
| Characterize the strains of rotavirus circulating in the community | 2002-2009 | Characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine |
| Assess rotavirus vaccine coverage | 2007-2009 | Assess rotavirus vaccine coverage in Rhode Island |
Countries
United States
Outcome results
None listed