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NCT01871038 · ClinicalTrials.gov registry record
Effectiveness of Monovalent Rotavirus Vaccine (RV1)
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- 362
- Enrollment target
NCT01871038: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01871038 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 362 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01871038 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- 362 participants
- Enrollment target
Study 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.
Primary Outcome
RV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were at least 52 days of age. The recommend age for the first dose is 42 days, but children are considered vaccinated if they receive that dose within 4 days of the recommended age, which lowers the acceptable minimum age to 38 days. We added 14 days to enable them to mount an immune response to arrive at a minimum age of 52 days. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2009-07 |
| Est. Completion | 2012-06 |
What the finished NCT01871038 record still lists
NCT01871038 is an observational study that tracks outcomes without assigning an intervention. The registered 362 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01871038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01871038 about?
NCT01871038 is a clinical study titled "Effectiveness of Monovalent Rotavirus Vaccine (RV1)". 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, 2...
What is the current status of trial NCT01871038?
This trial is currently completed. The enrollment target is 362 participants. The study started on 2009-07. Estimated completion is 2012-06.
Who is sponsoring clinical trial NCT01871038?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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