Status:
COMPLETED
Rotarix Vaccine Effectiveness
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
GlaxoSmithKline
Medical University of South Carolina
Conditions:
Rotavirus
Acute Gastroenteritis
Eligibility:
All Genders
Up to 5 years
Brief 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 Univ...
Detailed Description
A case-control design will be utilized to assess the effectiveness of RV1 in preventing rotavirus-associated hospitalizations and Emergency Department (ED) visits using cases and controls from the 200...
Eligibility Criteria
Inclusion
- the child is \< 6 years of age
- for vaccine effectiveness analysis, the child was born on or after 8/10/2008
- the child is being evaluated at Cincinnati Children's Hospital Medical Center or the Medical University of South Carolina 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
2268 Patients enrolled
Trial Details
Trial ID
NCT01871038
Start Date
July 1 2009
End Date
June 1 2012
Last Update
June 6 2013
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425