Effectiveness of Monovalent Rotavirus Vaccine (RV1)
United States362 participantsStarted 2009-07
Plain-language summary
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.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 usi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Matched VE Participants in the Minimum Age Model
Timeframe: 14 days from the date of enrollment
2
Vaccine Effectiveness of RV1 in the Minmum Age Model
Timeframe: 14 days from the date of enrollment
3
Matched VE Participants in the Maximum Age Model
Timeframe: 14 days from the date of enrollment
4
Vaccine Effectiveness of RV1 in the Maximum Age Model
Timeframe: 14 days from the date of enrollment
Trial details
NCT IDNCT01871038
SponsorChildren's Hospital Medical Center, Cincinnati