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Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island

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ClinicalTrials.gov Identifier: NCT01026779
Recruitment Status : Active, not recruiting
First Posted : December 4, 2009
Last Update Posted : August 24, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Penelope H. Dennehy, 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.

Condition or disease
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
Estimated Enrollment : 560 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island: Active Hospital-Based Surveillance, Serotype Surveillance and a Case-Control Study
Study Start Date : July 2009
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions [ Time Frame: 2007-2009 ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 2007-2009 ]
  2. Identification of risk factors for non-receipt of rotavirus vaccine [ Time Frame: 2007-2009 ]
  3. Characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine [ Time Frame: 2002-2009 ]
  4. Assess rotavirus vaccine coverage [ Time Frame: 2007-2009 ]

Biospecimen Retention:   Samples Without DNA
Stools


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Residents of Rhode Island
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026779


Locations
United States, Rhode Island
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Lifespan
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Penelope H Dennehy, MD Rhode Island Hospital

Responsible Party: Penelope H. Dennehy, Principal Investigator, Lifespan
ClinicalTrials.gov Identifier: NCT01026779     History of Changes
Other Study ID Numbers: HCH-001
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD since the study uses a deidentified dataset and deidentified stool specimens for serotype analysis

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Penelope H. Dennehy, Lifespan:
rotavirus
gastroenteritis
vaccine
case-control study
serotype

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs