Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Lifespan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Lifespan
ClinicalTrials.gov Identifier:
NCT01026779
First received: December 2, 2009
Last updated: December 3, 2009
Last verified: December 2009
  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.


Condition
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

Resource links provided by NLM:


Further study details as provided by Lifespan:

Primary Outcome Measures:
  • Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions [ Time Frame: 2007-2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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.
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.

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
Study Population

Residents of Rhode Island

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026779

Locations
United States, Rhode Island
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Lifespan
Merck Sharp & Dohme Corp.
Investigators
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:
rotavirus
gastroenteritis
vaccine
case-control study
serotype

Additional relevant MeSH terms:
Gastroenteritis
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014