Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island

Completed

• Conditions: Rotavirus Gastroenteritis

• Registration Number: NCT01026779
• Lead Sponsor: Lifespan

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Status Verified: 2019-11
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Last Update Submitted: 2019-11-12
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 803

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations	2007-2009	Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hasbro Children's Hospital; 🇺🇸 Providence, Rhode Island, United States