Effectiveness of Human Rotavirus Vaccine, Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00655187
First received: April 1, 2008
Last updated: November 25, 2011
Last verified: November 2011
  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 Intervention
Rotavirus Severe Gastroenteritis
Other: Collection of information
Procedure: Collection of stool samples

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Case-control Study to Evaluate the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children < 5 Years of Age in KK Hospital, Singapore

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To estimate the proportion of acute RV GE hospitalisations in children < 5 years of age. [ Time Frame: At least one year ] [ Designated as safety issue: No ]
  • 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: At least one year ] [ Designated as safety issue: No ]

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: At least one year ] [ Designated as safety issue: No ]
  • To determine the distributions of acute RV GE associated hospital admissions according to subject's age, gender and by month of year. [ Time Frame: At least one year ] [ Designated as safety issue: No ]
  • To estimate the prevalence of RV genotypes in acute RV GE associated hospital admission. [ Time Frame: At least one year ] [ Designated as safety issue: No ]
  • To review the trend of acute RV GE and acute GE admissions over the entire study period. [ Time Frame: At least one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Stool samples


Enrollment: 1270
Study Start Date: April 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
Cases
Other: Collection of information
Information regarding demographic characteristics, medical history, previous participation in rotavirus clinical trials and vaccination history will be collected.
Procedure: Collection of stool samples
Stools samples will be collected during hospitalisation for RV testing and genotyping of RV positive samples.
Group B
Controls
Other: Collection of information
Information regarding demographic characteristics, medical history, previous participation in rotavirus clinical trials and vaccination history will be collected.

Detailed Description:

This Protocol Posting has been updated following an amendment of the Protocol.

  Eligibility

Ages Eligible for Study:   up 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) and whose parents/ guardians are willing to provide informed consent, will be considered as cases.

Cases will be limited to those subjects who are born after 1 November 2005, aged at least 16 weeks and whose stool samples have been tested positive for rotavirus (RV).

For each case, two controls hospitalised for acute disease with non-GE causes in the same hospital during the same period, will be included in the study after matching them by date of birth.

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 cases

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.
  • whose stool samples are tested positive for RV. Selection criteria 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 case , with the closest admission date to the cases.
  • Aged at least 16 weeks at the time of hospital admission.
  • Born 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 cases

In addition to the exclusion criteria for surveillance subjects, 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.
  • Subjects who have been already enrolled in the study.
  • Subjects whose vaccination history could not be ascertained. 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 or had an episode of GE within 14 days prior to the day of interview.
  • Child who has been already enrolled in the study as case or control.
  • The onset of GE occurs after admission at the hospital.
  • Child whose vaccination history could not be ascertained.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655187

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00655187     History of Changes
Other Study ID Numbers: 110467
Study First Received: April 1, 2008
Last Updated: November 25, 2011
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 23, 2014