Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island
Recruitment status was Active, not recruiting
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Purpose
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.
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Rotavirus Gastroenteritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island: Active Hospital-Based Surveillance, Serotype Surveillance and a Case-Control Study |
- Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions [ Time Frame: 2007-2009 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Identification of risk factors for non-receipt of rotavirus vaccine [ Time Frame: 2007-2009 ] [ Designated as safety issue: No ]
- Characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine [ Time Frame: 2002-2009 ] [ Designated as safety issue: No ]
- Assess rotavirus vaccine coverage [ Time Frame: 2007-2009 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Stools
| Estimated Enrollment: | 560 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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.
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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.
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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.
Eligibility| Ages Eligible for Study: | 2 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Residents of Rhode Island
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
Contacts and Locations| United States, Rhode Island | |
| Hasbro Children's Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| Principal Investigator: | Penelope H Dennehy, MD | Rhode Island Hospital |
More Information
No publications provided
| Responsible Party: | Penelope H. Dennehy, M.D., Lifespan |
| ClinicalTrials.gov Identifier: | NCT01026779 History of Changes |
| Other Study ID Numbers: | HCH-001 |
| Study First Received: | December 2, 2009 |
| Last Updated: | December 3, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Lifespan:
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rotavirus gastroenteritis vaccine case-control study serotype |
Additional relevant MeSH terms:
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Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013