Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island

NCT ID: NCT01026779

Last Updated: 2019-11-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 803 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2019-11-01

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.

Conditions

Rotavirus Gastroenteritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Lifespan

OTHER

Sponsor Role: lead

Responsible Party

Penelope H. Dennehy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Penelope H Dennehy, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Hasbro Children's Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

HCH-001

Identifier Type: -

Identifier Source: org_study_id