Effectiveness of Monovalent Rotavirus Vaccine (RV1)

NCT01871038 | Completed Results

• 1 other identifier: 111725
• Study Type: observational
• Target: 362
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Rotavirus; Acute Gastroenteritis

Keywords

vaccine effectiveness; rotavirus; acute gastroenteritis

Outcome Measures

Primary Outcomes (4)

• Matched VE Participants in the Minimum Age Model

  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.

  14 days from the date of enrollment

• Vaccine Effectiveness of RV1 in the Minmum Age Model

  RV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were age-eligible to receive at least the first dose of RV1 vaccine. Only valid RV1 vaccinations were considered. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses. VE was estimated as (1 - exposure odds ratio) x 100.

  14 days from the date of enrollment

• Matched VE Participants in the Maximum Age Model

  RV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were at least 8 months of age, the maximum recommend age for completion of 2 doses of RV1. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses.

  14 days from the date of enrollment

• Vaccine Effectiveness of RV1 in the Maximum Age Model

  RV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were greater than or equal to 8 months of age, the maximum recommended age for completion of two doses of RV1 vaccine. Only valid RV1 vaccinations were considered. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses. VE was estimated as (1 - exposure odds ratio) x 100.

  14 days from the date of enrollment

Study Arms (2)

Rotavirus Positive Cases

This group includes all participants who submitted a stool specimen that tested positive for Rotavirus.

Rotavirus Negative Controls

This group includes all participants who submitted a stool specimen that tested negative for Rotavirus.

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children who are an inpatient or a patient of the Emergency Department with symptoms of acute gastroenteritis.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• GlaxoSmithKline: collaborator
• Medical University of South Carolina: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool specimen

Limitations and Caveats

Limitations of the study include very low numbers of rotavirus cases and temporary halt in use of Rotarix vaccine due to presence of porcine virus in the vaccine which resulted in several children receiving mixed doses of vaccine and a delayed uptake in Rotarix vaccine.

Results Point of Contact

• Title: Dr. Mary Allen Staat
• Organization: Cincinnati Childrens Hospital Medical Center

mary.staat@cchmc.org

513-636-7083

Study Officials

• Mary A Staat, MD, MPH

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: June 6, 2013
• Study Start: July 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2026-01

Locations

US (1)