N/A
N=362
Effectiveness of Monovalent Rotavirus Vaccine (RV1)
Rotavirus · Acute Gastroenteritis
Bottom Line
View on ClinicalTrials.gov: NCT01871038 ↗Enrolled (actual)
362
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Matched VE Participants in the Minimum Age Model — 31; 70; 6; 31 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Matched VE Participants in the Minimum Age Model |
31; 70; 6; 31; 12; 81 | — |
| PRIMARY Vaccine Effectiveness of RV1 in the Minmum Age Model |
69; 59 | — |
| PRIMARY Matched VE Participants in the Maximum Age Model |
24; 83; 3; 29; 11; 171 | — |
| PRIMARY Vaccine Effectiveness of RV1 in the Maximum Age Model |
82; 77 | — |
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.
Eligibility Criteria
Inclusion Criteria
- the child is =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 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.
Data sourced from ClinicalTrials.gov (NCT01871038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.