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Effectiveness of Human Rotavirus Vaccine, Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants.
This study is currently recruiting participants.
Verified by GlaxoSmithKline, October 2008
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00655187
  Purpose

This study aims to evaluate the effectiveness of Rotarix™ vaccine in the general population in Singapore by monitoring the overall reduction in RV SGE and also by assessing the direct protection offered by the vaccine in hospitalised infants through a case-control study.


Condition
Rotavirus Severe Gastroenteritis

MedlinePlus related topics: Gastroenteritis
Drug Information available for: RotaTeq
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Hospital-Based, Case-Control Study to Assess the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children < 5 Years of Age in KK Hospital, Singapore.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis (RV SGE) among children born after 1 November 2005 and aged at least 16 weeks. [ Time Frame: 2 years ]
  • To estimate the proportion of acute RV GE hospitalisations in children < 5 years of age. [ Time Frame: 2 years. ]

Secondary Outcome Measures:
  • To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing hospitalisation for acute RV GE among children born after 1 November 2005 and aged at least 16 weeks. [ Time Frame: 2 years ]
  • To determine the distributions of acute RV GE associated hospital admissions according to subject's age, gender and by month of year. [ Time Frame: 2 years. ]
  • To estimate the prevalence of RV genotypes in acute RV GE associated hospital admission. [ Time Frame: 2 years. ]
  • To review the trend of acute RV GE and acute GE admissions over the entire study period. [ Time Frame: 2 years. ]
  • To assess the costs of hospitalisation and loss of working days, due to RV SGE and SGE. [ Time Frame: 2 years. ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Stool samples


Estimated Enrollment: 960
Study Start Date: April 2008
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Weeks to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children less than 5 years of age, hospitalised with acute GE, living in Singapore served by the hospital participating in the study (KK Hospital) (cases) and children who were born after 1 November 2005, aged at least 16 weeks and hospitalised for acute disease with non-GE causes in the same hospital, will be included in the study after matching them by date of birth (controls).

Criteria

Inclusion Criteria:

Inclusion criteria for surveillance subjects

  • A male or female child aged < 60 months at the time of admission (a child becomes ineligible on the day of its fifth birthday).
  • Subject admitted with acute GE as an inpatient to the study site during the study period.
  • Written informed consent obtained from the parent or guardian of the subject.

Selection criteria

For potential cases

Potential cases will be limited to those surveillance subjects:

  • who are born after 1 November 2005 (date of availability of Rotarix™ vaccination in Singapore),
  • who are aged at least 16 weeks at the time of hospital admission.

For confirmed cases

Confirmed cases will be limited to those potential cases

  • whose stool samples are tested positive for RV by immunochromatographic test.

For controls

All controls must satisfy the following criteria at study entry:

  • Admitted for acute disease with non-GE causes in the same hospital as the potential case.
  • Born after 1 November 2005 (corresponding to the date of availability of Rotarix™ vaccination in Singapore).
  • Aged at least 16 weeks at the time of hospital admission and matched with acute GE cases (potential cases) progressively by date of birth, within a range of ± 2 weeks from the date of birth of cases. In case there is no suitable match, then the range would be extended to ± 4 weeks.
  • Written informed consent obtained from the subject's parents/guardians.

Exclusion Criteria:

For enrolment of surveillance subjects

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

  • The diagnoses at admission to the study site do not include acute GE.
  • Children for whom stool samples are not available up to 48 hours after admission.
  • The onset of GE is after 48 hours of admission to the hospital (i.e. nosocomial GE).
  • Children with a history of chronic and genetic diseases.

For selection of potential cases

In addition to the exclusion criteria for surveillance subjects, potential cases will not be selected if the following criterion applies:

  • Subjects who had a previous episode of acute GE less than a week back i.e. recurrent GE episode.

For selection of controls

The following criteria should be checked at the time of study entry. If any apply, the controls must not be included in the study:

  • Child who has symptoms of GE on the day of interview of his/her parent or guardian.
  • The onset of GE occurs after admission at the hospital.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655187

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
Singapore
GSK Investigational Site Recruiting
Singapore, Singapore, 229899
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: 110467
Study First Received: April 1, 2008
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00655187  
Health Authority: Singapore: Health Sciences Authority

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on January 16, 2009