Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island

NCT01026779 | Completed

• 1 other identifier: HCH-001
• Study Type: observational
• Target: 803
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotavirus Gastroenteritis

Keywords

rotavirus; gastroenteritis; vaccine; case-control study; serotype

Outcome Measures

Primary Outcomes (1)

• Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations

  Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions

  2007-2009

Secondary Outcomes (4)

• Vaccine use outside the recommended age limits

  2007-2009

• Risk factors for non-receipt of rotavirus vaccine

  2007-2009

• Characterize the strains of rotavirus circulating in the community

  2002-2009

• Assess rotavirus vaccine coverage

  2007-2009

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Residents of Rhode Island

You may qualify if:

• rotavirus gastroenteritis requiring hospitalization
• immunocompetent
• born after April 15, 2006
• greater than 2 months of age on the day of admission

You may not qualify if:

• rotavirus vaccine contraindicated for that child based on ACIP/AAP recommendations
• an immunization record cannot be obtained through the KIDSNET database

Sponsors & Collaborators

• Lifespan: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stools

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Penelope H Dennehy, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 4, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 14, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)