Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island

Rotavirus Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026779
• Other study ID #: HCH-001
• Status: Completed
• Start date: July 2009
• Est. completion date: November 1, 2019

Study information

• Verified date: November 2019
• Source: Lifespan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 803
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

Locations

Country	Name	City	State
United States	Hasbro Children's Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Lifespan	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations	Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions	2007-2009
Secondary	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
Secondary	Risk factors for non-receipt of rotavirus vaccine	Identification of risk factors for non-receipt of rotavirus vaccine	2007-2009
Secondary	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
Secondary	Assess rotavirus vaccine coverage	Assess rotavirus vaccine coverage in Rhode Island	2007-2009