Overview

This trial is active, not recruiting.

Condition rotavirus gastroenteritis
Sponsor Lifespan
Collaborator Merck Sharp & Dohme Corp.
Start date July 2009
End date December 2016
Trial size 560 participants
Trial identifier NCT01026779, HCH-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective
Arm
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.
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.

Primary Outcomes

Measure
Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions
time frame: 2007-2009

Secondary Outcomes

Measure
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
Identification of risk factors for non-receipt of rotavirus vaccine
time frame: 2007-2009
Characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine
time frame: 2002-2009
Assess rotavirus vaccine coverage
time frame: 2007-2009

Eligibility Criteria

Male or female participants from 2 months up to 5 years old.

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

Additional Information

Official title Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island: Active Hospital-Based Surveillance, Serotype Surveillance and a Case-Control Study
Principal investigator Penelope H Dennehy, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Lifespan.