Effectiveness of Monovalent Rotavirus Vaccine (RV1)

Completed

Conditions studied: Rotavirus, Acute Gastroenteritis

In brief

To determine the effectiveness of rotavirus vaccines, active surveillance will be conducted at two sites, Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati, Ohio and the Medical University of South Carolina (MUSC) in Charleston, South Carolina. Children born on or after April 1, 2006 presenting to CCHMC as an inpatient or for a short-stay or Emergency Department (ED) visit with acute gastroenteritis (AGE) and/or fever will be approached for enrollment. Children will be eligible if they have vomiting and/or diarrhea less than or equal to 10 days duration. Data including demographic information, illness characteristics and socio-economic status will be collected from each patient. A sample of the patient's stool will be collected within 14 days of the onset of symptoms. Stool specimens will be tested for rotavirus antigen by Rotaclone at CCHMC. All rotavirus positive stool specimens will be typed for common G and P serotypes. Using the children identified with rotavirus as our cases and the children who were rotavirus negative as our controls, we will conduct a case control study to assess the effectiveness of rotavirus vaccines, in particular Rotarix.

Key facts

Study ID

NCT01871038

Run by

Children's Hospital Medical Center, Cincinnati

People needed

362

Starts

2009-07-01

Expected to finish

2012-06-01

Last updated by the study team

2026-01-26

Who can join

Age: any, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• the child is < 6 years of age
• for the vaccine effectiveness analysis using the Minimum Age Model, the child was included if born on or after 8/10/2008 at MUSC and on or after 12/1/2008 at CCHMC.
• for the vaccine effectiveness analysis using the Maximum Age Model, the child was included if >=8 months of age.
• the child is being evaluated at Cincinnati Children's Hospital Medical Center (CCHMC) or the Medical University of South Carolina (MUSC) as an inpatient, short-stay visit or in the emergency department
• the child has acute gastroenteritis defined as
• diarrhea (>3 loose stools in a 24 hour period) OR
• -vomiting (>1 episodes in a 24 hour period)
• the child's illness is of <10 days duration
• written consent is obtained from the child's parent or legal guardian

You may not qualify if…

• the child is >6 year of age
• the child had onset of fever or gastroenteritis symptoms > 10 days prior to admission
• the child has a non-infectious or other identifiable cause of their symptoms, such as head trauma, pyelonephritis, pyloric stenosis, or prolonged coughing
• the child is immunocompromised
• there is no parent or guardian available
• the parent/guardian is non-English speaking
• previously enrolled for the same episode of gastroenteritis
• for the vaccine effectiveness analysis using the Minimum Age Model, the child was excluded if born prior to 8/10/2008 at MUSC and prior to 12/1/2008 at CCHMC.
• for the vaccine effectiveness analysis using the Maximum Age Model, the child was excluded if <8 months of age.

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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