Rotarix vaccine shows strong protection against severe rotavirus in kids
NCT ID NCT01871038
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at how effective the Rotarix vaccine is at preventing severe rotavirus infections in children under 6 years old. Researchers enrolled 362 children with acute gastroenteritis at two U.S. hospitals, comparing those who tested positive for rotavirus (cases) with those who tested negative (controls). By analyzing vaccination records, they estimated the vaccine's effectiveness in real-world conditions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rotarix (RV1) vaccine
- What this could lead to
- If successful, this study confirms that Rotarix effectively prevents severe rotavirus infections in young children, supporting continued vaccine use.
- What could go wrong
- This is an observational case-control study, not a randomized trial, so results may be influenced by unmeasured factors. Vaccine effectiveness can vary by region and circulating strains.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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362 people
The number who actually took part.
- Start date
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Jul 2009
- Finished
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Jun 2012
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Children who are an inpatient or a patient of the Emergency Department with symptoms of acute gastroenteritis.
- Ages
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Up to 5 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 using the Maximum Age Model, the child was excluded if \<8 months of age.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.