Clinical trial NCT01026779: Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island
Official title: Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island: Active Hospital-Based Surveillance, Serotype Surveillance and a Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotavirus Gastroenteritis
Keywords: rotavirus
gastroenteritis
vaccine
case-control study
serotype
Lead sponsor: Lifespan
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-12-04
Enrollment: 803
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents of Rhode Island

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations
timeFrame: 2007-2009
Secondary outcomes:
measure: Vaccine use outside the recommended age limits
timeFrame: 2007-2009
measure: Risk factors for non-receipt of rotavirus vaccine
timeFrame: 2007-2009
measure: Characterize the strains of rotavirus circulating in the community
timeFrame: 2002-2009
measure: Assess rotavirus vaccine coverage
timeFrame: 2007-2009
Other outcomes:
Locations:
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Penelope H Dennehy, MD
role: PRINCIPAL_INVESTIGATOR
References: