Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island

Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island: Active Hospital-Based Surveillance, Serotype Surveillance and a Case-Control Study

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.

Study Overview

• Status: Completed
• Conditions: Rotavirus Gastroenteritis

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.

• Study Type: Observational
• Enrollment (Actual): 803

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Hasbro Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Residents of Rhode Island

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations	Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions	2007-2009

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine use outside the recommended age limits	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	2007-2009
Risk factors for non-receipt of rotavirus vaccine	Identification of risk factors for non-receipt of rotavirus vaccine	2007-2009
Characterize the strains of rotavirus circulating in the community	Characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine	2002-2009
Assess rotavirus vaccine coverage	Assess rotavirus vaccine coverage in Rhode Island	2007-2009

Collaborators and Investigators

• Sponsor: Lifespan
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Penelope H Dennehy, MD, Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: December 2, 2009
• First Submitted That Met QC Criteria: December 3, 2009
• First Posted (Estimate): December 4, 2009

Study Record Updates

• Last Update Posted (Actual): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: vaccine; rotavirus; gastroenteritis; case-control study; serotype
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: HCH-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share IPD since the study uses a deidentified dataset and deidentified stool specimens for serotype analysis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No